Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: The purpose of this job is to support BDM infrastructure committees, vendor oversight, provide project management activities, interface with technical study teams and other departments on BDM and cross R&D or cross Business Unit initiatives. Responsibilities: - Serve as Project Manager for BDM initiatives and BDM Functional Excellence. Create and maintain tracking logs for Infrastructure Committees, drive expected follow-up activities per the action log, and become the point person for status updates - Coordinate and chair meetings for BDM or cross departmental non-project related initiatives and/or brainstorming sessions - Develop BDM or cross-RD/Business Unit information bulletins or training to support continuous reinforcement of decisions from the BDM Governance committees - Remain current with HA Regulation/Guidelines, ICH, and Literature to provide broad basis of information to support/challenge proposals submitted to the BDM Governance committees. Summarize and disseminate impact of guidance changes to BDM across all functions. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university); - Master's Degree in life sciences or related field preferred - Bachelor's Degree in life sciences or related field preferred Experience Qualifications - 7 or More Years Training in Lean/six sigma, brainstorming, or Quality Engineering preferred - 7 or More Years with Bachelor's degree (or Master's degree with minimum of 5 years) experience within pharmaceutical industry or CROs. preferred Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

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Associate Director, BDM Planning and Functional Excellence

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: This position supports early phase oncology development and leads complex studies in study design, statistical analysis and interpretation of results with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted to Health Authorities globally with some supervision. This position also guides contract research organization (CRO) programmers and statisticians in preparing analysis files and performing statistical analyses. Additionally, this position interacts with study teams, as well as statisticians and programmers at CROs. This position works under some supervision to solve complex study problems. Responsibilities:<ul><li>Protocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies including study design, protocol development, CRF review, SAP development, analysis files development, statistical analysis accuracy validation, results interpretation and CSR input and review. Acts as main statistical contact for the assigned studies and projects. Provides guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data.</li><li>Drug Development Strategy: Provides input to multiple aspects of the development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.</li><li>CRO / Vendor Oversight: Review CRO/vendor proposal and budget. Establishes procedures through regular interaction, setting expectation on deliverables and timelines to guide CRO biostatistician and statistical programmers on complex studies. Ensures deliverables are accurate and delivered according to the timelines.</li><li>Global Health Authority Interaction / Negotiation: Contributes to documents submitted to Health Authorities globally by providing input for the interaction or by writing the interaction document. May participate in meeting or teleconferences with Health Authorities</li><li>Global BDO Strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex initiatives, with some level of supervision, to improve the harmonization and efficiency of drug development which leads to cost savings and shortened timelines for the company.</li></ul>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education:<ul><li>Master's Degree in statistics or biostatistics required</li><li>PhD in statistics or biostatistics preferred Experience Qualifications</li><li>8+ Years of relevant experience in the pharmaceutical industry with a masters degree required</li><li>5+ Years of relevant experience in the pharmaceutical industry with a PhD preferred</li></ul>Travel:<ul><li>Ability to travel up to 10%</li></ul>Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Associate Director, Biostatistics - Early Development

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: Position leads complex studies in study design, statistical analysis and interpretation of results with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted to Health Authorities globally with some supervision. This position also guides contract research organization (CRO) programmers and statisticians in preparing analysis files and performing statistical analyses. Additionally, this position interacts with study teams, as well as statisticians and programmers at CROs. This position works under some supervision to solve complex study problems. Responsibilities:<ul><li>Protocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies including study design, protocol development, CRF review, SAP development, analysis files development, statistical analysis accuracy validation, results interpretation and CSR input and review. Acts as main statistical contact for the assigned studies and projects. Provides guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data.</li><li>Drug Development Strategy: Provides input to multiple aspects of the development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.</li><li>CRO / Vendor Oversight: Review CRO/vendor proposal and budget. Establishes procedures through regular interaction, setting expectation on deliverables and timelines to guide CRO biostatistician and statistical programmers on complex studies. Ensures deliverables are accurate and delivered according to the timelines.</li><li>Global Health Authority Interaction / Negotiation: Contributes to documents submitted to Health Authorities globally by providing input for the interaction or by writing the interaction document. May participate in meeting or teleconferences with Health Authorities</li><li>Global BDO Strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex initiatives, with some level of supervision, to improve the harmonization and efficiency of drug development which leads to cost savings and shortened timelines for the company.</li></ul>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education:<ul><li>Master's Degree in statistics or biostatistics required</li><li>PhD in statistics or biostatistics preferred experience</li></ul>Qualifications:<ul><li>8+ Years of relevant experience in the pharmaceutical industry with a master's degree required</li><li>5+ Years of relevant experience in the pharmaceutical industry with a PhD preferred</li></ul>Travel: <ul><li>Ability to travel up to 10%</li></ul>Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Associate Director, Biostatistics - Oncology

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: The Associate Director, Data Management Processes, Training and Inspection Readiness, is accountable for the end-to-end delivery of data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs and other vendors to ensure high quality of deliverables to support drug development processes and global submissions. This position provides leadership within Data Management by partnering with internal and external stakeholders to optimize processes, technology, and standards. This position ensures quality delivery of data for clinical trials, clinical development, and regulatory submissions. This position develops and proposes strategies for ensuring all clinical trials meets quality requirements and best practices. This position serves as a subject matter expert for internal data management resources in operating processes, department training, and inspection readiness. This position requires an excellent knowledge of Data Management services and scope, training requirements and provision, as well as inspection readiness and regulatory requirements. This position requires excellent verbal/written skills, analytical, organizational, and interpersonal skills and works effectively with people at different levels and from different disciplines and cultures. Additionally, this position possesses advanced knowledge of medical terminology capture and reporting of safety data, pharmacovigilance, industry best practices, and relevant regulatory requirements. This position has experience working within the medical device and/or pharmaceutical industry across complex disease areas, and experience with regulatory submissions and inspections. This position requires skills in working in a fast-paced environment, continuous improvement, project management, change management, and risk management. Responsibilities: Leadership, Direction, and Strategy: Leads development and implementation of Data Management departmental strategy and solutions related to process development, improvement, and training. Lead and coordinate development of DM processes and templates and ensure consistent execution of tasks and activities across programs. Identifies opportunities for process and workflow improvements and collaborates with Data Management SMEs in review and improvement to ensure department procedures are streamlined to meet quality and efficiency goals. Collaborate with multifunctional teams within BDM operations to understand requirements and recommend training needs, processes, standards, and governance across the department. Participate in and contribute to BDM-led committees [CRO governance, standards, systems] to assess and/or implement any changes that are required to department training, compliance, or operations. Ensure appropriate Data Management representation and contribute to cross-functional SOPs, development, and revisions. Coordinate and manage updates to cross-functional SOPs. Champions and facilitates change management through providing rationales, describing improved outcomes and increased efficiency to achieve regulatory compliance and/or operational excellence. Models and reinforces adherence to Daiichi Sankyo standards to Daiichi Sankyo program teams, ensures consistency in understanding and implementation of standards across Daiichi Sankyo programs. Promotes Daiichi Sankyo values and quality workplace culture, collaboration in cross-functional and multicultural settings, and builds and maintains positive relationships with internal/external stakeholders/vendors/partners. Project Management: Track and coordinate periodic review and renewal of Daiichi Sankyo Data Management SOPs/SOIs, along with associated templates, with appropriate departmental SMEs. Support SMEs and DM Leadership Team quality improvement initiatives within Data Management while also representing the department in multi-function Daiichi Sankyo initiatives. Organize frequent department drop-in sessions to review various processes, gather feedback, and provide additional training/guidance. Review available role-specific Data Management training modules and identify any gaps or areas for improvement. Functional Expertise: Prepares internal teams for audits and compliance. Develops a framework for preparation, participation, and follow-ups or corrective actions. Participates in external audits and inspections as a DM representative. Collaborate with departmental SMEs to identify gaps in knowledge and prepare training materials accordingly if necessary. Ensures adherence to data processes, methodologies, data standards, and technologies for quality delivery of DM services. Serve as a SME to DM data standards team and represents function to standards team as an extended part of committee. Organize and perform mock inspections of DM activity execution on clinical trials and review of the study TMF. Perform root cause analysis based on the findings from the inspections, and present findings and propose solutions to the leadership team for consideration of quality and process improvements. Operational Efficiency / Continuous Improvement: Lead knowledge sharing, training sessions, and facilitate lessons learned discussions within the department. Leverages comprehensive Data Management and procedure compliance expertise to promote and implement best practices across the Clinical Trial lifecycle. Remains current with and disseminates information about compliance updates and advancements, regulatory requirements, and emerging technology innovations. Develops and maintains networks with thought leaders in data management.10% Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) - Bachelor's Degree in life sciences or related field required - Master's Degree in life sciences or related field preferred Experience Qualifications: - 7 or more years training and compliance background and strong knowledge of FDA and EU regulatory requirements, industry audit processes, and Data Management best practices required. - Additionally, strong knowledge of GCP, GDP, and 21 CFR preferred - 7 or more years' experience in clinical data management experience in a medical device, pharmaceutical company, or similar environment (e.g., CRO); oncology, immunology, or complex disease preferred - 7 or more years of working knowledge of Clinical trial data systems and/or EDC lab management tools is a preferred Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Associate Director, Data Management Processes, Training, and Inspection Readiness

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary:<ul><li>This position is responsible for providing project management and operational expertise as part of the Project Management Office and Business Excellence (PMOBE) sub-function within Clinical Safety and Pharmacovigilance (CSPV).</li><li>PMOBE the strategic planning and implementation group within CSPV. The Associate Director PMOBE manages CSPV strategic projects, supports business process optimization initiatives, and directs operational structures and oversight.</li><li>This position collaborates within global CSPV and cross-functional teams.</li><li>As a project manager this position is accountable for partnering with the business lead to ensure effective team operations through meeting management, development plan/timeline management, scope management, stakeholder management, risk/issue management, finance and resource management, and conflict resolution.</li><li>As a member of the CSPV function this position is also accountable for supporting divisional and departmental level objectives and may also participate on a non-project initiative in support of these objectives. This position will report to the Sr. Director, Management Office & Business Excellence in CSPV.</li></ul>Responsibilities: Project Management: <ul><li>Responsible for planning, managing, and coordinating projects within DSI CSPV and global clinical safety and epidemiology function.</li><li>Deliver the project according to plan within contracted time frame and budget, meeting quality standards.</li><li>Determine the critical success factors for the engagement in collaboration with the business lead, and report progress against budget, resources, and time frames to CSPV Leadership.</li><li>Manages meetings communications strategies, including developing agendas and documenting decisions and action items.</li><li>Follows through on assignments and ensures team members deliver on action items.</li><li>Identifies organizational gaps and influences the project environment to address gaps that impact the expected business outcome.</li><li>Identifies and recommends PM best practices for the broader CSPV organization.</li></ul> Business Excellence: <ul><li>Develop and implement operational best practices in partnership with CSPV Leadership based on business need.</li><li>Support process mapping and design workshops.</li><li>Provide oversight and support for operational groups, related processes, and metrics in CSPV.</li><li>Conduct impact analysis of process redesign on existing organization roles, principles, and technical infrastructure in collaboration with business SMEs and CSPV Leadership.</li></ul>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) <ul><li>Bachelor's Degree within a scientific discipline required; a post graduate degree such as MBA, MS or PhD along with additional relevant experience preferred.</li></ul> Experience Qualifications <ul><li>7 or More Years Experience in the pharmaceutical industry required</li><li>4 or More Years Experience in Project Management required</li><li>Prior experience in patient safety and pharmacovigilance preferred</li><li>Experience in process design preferred Licenses and Certifications</li><li>Project Management Professional (PMP) Certification and/or training in project management is preferred</li><li>Ability to travel up to 10%</li></ul> Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Associate Director, Project Management & Business Excellence, CSPV

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: The purpose of this job is to provide statistical programming technical support to DSI project teams on all statistical programming deliverables and programming submission. It will also improve Daiichi Sankyo programming efficiency by developing tools and macros and build up standard on SDTM/ADaM datasets, and TFLs. Responsibilities: - Supporting project lead on outsourced projects, act as statistical programming subject matter expert (SME) to support outsourced programming activities and be responsible for the programming technical decision. By guiding other internal programmer or by self, perform programmatic review of Study Date Tabulation Model (SDTM) and analysis (including Analysis Data Model (ADaM)) datasets as well as TLFs generated by statistical vendor, ensure correct and effective vendor programming implementation, and expedite the preparation of regulatory submissions. Responsibilities include: make strategic programming decision and planning, review Case Report Form (CRF) annotation and SDTM dataset, identify data inconsistencies and support data review, review analysis dataset specifications and ensure correct interpretation of SAP, develop independent programs to validate stud level analysis dataset and TLFs generated by vendor, ensure analysis dataset in compliance with CDISC and submission requirement, review study submission data package and ensure its quality and integrity. - Provide hands-on statistical programming support to regulatory submission and help submission team in quick turnaround in response to regulatory agencies. Responsibilities include: develop programming submission strategy, perform integrated analysis of efficacy and safety, generate submission data package, create TLFs to support submission QAs, perform ad-hoc and exploratory analysis requested by clinical team, and support agency response or potential Advisory Committee Meeting - Develop DSI programming standard template on datasets and TFLs to improve efficiency and quality. Responsibilities include: contribute to CRF and SDTM standard development, develop, implement, and maintain SDTM, ADaM dataset and TLF standard, develop sample programs to generate and validate SDTM, ADaM dataset and TLFs, support technical training and ensure effective implementation of SDTM, ADaM and TLFs standard in clinical trial data analysis - Develop and maintain necessary programming macros or tools to effectively support all programming needs. Responsibilities include: identify the macros or tools that will facilitate programing efficiency, lead the macro or tool development by working with contractors or by self, and support the macro or tool implementation and maintenance - Evaluate, assess and enhance DSI computing environment system. Responsibilities include: continue assessing DSI new computing environment system for programming and analysis efficiency, identify system bug/issue and lead the activity to enhance the system, develop system training materials and work as the SME to support implementation, evaluate, request and approve system upgrades, and propose/develop system utilities Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) - Bachelor's Degree an accredited institution in a science or in a technical field preferred - Master's Degree preferred Experience Qualifications - 10 or More Years proven experience within pharmaceutical industry, or CROs supporting statistical analysis of clinical trials programming preferred - 7 or More Years proven experience within pharmaceutical industry, or CROs supporting statistical analysis of clinical trials programming with Masters degree preferred - Previous experience supporting SAS macro and/or system utility development preferred - Advanced working knowledge of all aspects of the SAS programming language used in clinical trials programming preferred - Advanced working knowledge of CDISC SDTM and ADaM, and extensive experiences of their implementation in clinical trials analysis preferred - Advanced understanding of statistical concepts in support of analyses and reporting of clinical trials preferred - Knowledge of all phases of drug development, including early and late phase clinical development and submission preferred - Solid background in applied statistics preferred - Solid knowledge of new advanced statistical methods using SAS and R preferred - Advanced knowledge in database structures and set-up preferred Travel: Ability to travel 10% Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Associate Director, Statistical Programming

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Individual will be responsible to develop and lead the Global Oncology Congress strategy and objectives for the organization. This person will have strategic oversight planning and execution for global oncology congresses and branding activities. Individual will lead the coordination and collaboration across global and regional cross-functional teams and agency partners to ensure the successful organization of global congresses to meet corporate goals and strengthen perceptions of the DS Oncology Portfolio. Responsibilities - Lead Global Oncology CongressesResponsible for the overall Global Oncology Congress annual strategy, innovation and execution of all key global oncology congress-related activities across multi-disciplinary teams (e.g. Corporate Programs and Events, RD, Medical, Marketing and global colleagues) to ensure alignment and maximization of activities in support of the Oncology franchise. - Chair the Joint Steering Committee (JSC) for Global Oncology Congresses to ensure alignment on overall congress presence, strategic priorities, and budget investments. - Lead global planning with functional leads to coordinate strategic alignment of all key elements of global congress planning and execution such as sponsorship activities, booth design and logistics, communications, registration badges and housing, on-site preconference and other key meetings, scientific exchange, media events and competitive intelligence. - Leverage post-congress activities to evaluate impact, innovate and enhance DS global oncology congress presence. These inputs include key communication follow-up, post congress survey, post congress logistic debrief, exhibit metrics and leads captured, and competitive intelligence. - Oversee overall congress communication plan throughout the organization. - Congress Content and Asset ManagementOversee the global congress oncology development and management of pipeline content and related assets to showcase the breadth and depth of the DS oncology pipeline. Responsible for ensuring all congress related sponsorship marketing tactics align with the global congress strategic imperatives and individual congress meeting priorities. - Ensure the global oncology pipeline content and related assets are updated regularly to align with RD and global corporate communications approved schedule, guidance, and criteria. - Oversee the creation, approval and execution of all sponsorship corporate branded advertisements and promotional activities at global congresses. - Ensure all congress materials are global, region and/or local approved by legal and compliance authorities based on the location of the congress. - Relationship ManagementCo-lead association relationship with Global Medical Affairs - Support all Programs Grants Committee (PGC) sponsorship submission approvals. - Oversee charitable contribution approvals in partnership with global advocacy as it relates to global oncology congresses. -Full oversight and management of the creative agency - Budget management and control - Evaluation of individual congress projects - DXd ADC Technology Brand - Lead the development and implementation of the DXd ADC Technology brand campaign. This includes the global strategy, tactics, and budget management. Responsible for content creation including key messaging, external awareness and education tactics such as website development, media initiatives and coordination with corporate communications, global medical affairs and regional implementation teams. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) - Bachelor's Degree required, preferably with an emphasis in health sciences - MBA or advanced scientific degree preferred Experience Qualifications - 10 or More Years in pharmaceutical/biotech commercial industry experience including established competency in global congress planning or global brand marketing required - Oncology therapeutic area experience preferred Travel Ability to travel up to 40% Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Director Global Oncology Congress Strategy & Branding

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: Position leads very complex studies or entire drug project in study design, data analysis and interpretation of results independently with minimal supervision. This position provides input to entire drug development plans with minimal supervision and authors regulatory responses and other documents with minimal supervision. This position interacts with global project teams and global Health Authorities, as well as contract research organization (CRO) programmers and statisticians. Additionally, this position works under minimal supervision to solve complex project problems. Responsibilities: - Protocol Development, Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and Clinical Study Report (CSR): Leads statistical activities for very complex studies or an entire project. Act as statistical expert in the assigned projects. Guides the project team in using the most efficient or innovative study design by considering the regulatory agencies' requirements for the country and Regions the compound will be submitted, and helps to maximize the success of the drug product.Serves as project statistician and ensures the study designs are scientifically sound, the efficacy and safety information meets regulatory requirements of the countries and Regions the drugs will be submitted. Ensures consistency in data collection, derived data definition, analysis file structure, statistical analysis and result interpretation throughout the drug project; Leads the planning and analysis of integrated efficacy and safety data; Review the relevant sections of the electronic common technical document (eCTD). - Drug Development Strategy: Provides input to the entire development plan to ensure the overall strategy can deliver the pre-specified product profile, is logical, scientifically sound, proposed studies have appropriate designs, efficacy and safety information to be collected meet regulatory agencies' requirements for countries and regions the drug is to be submitted.Research statistical methodologies and addresses specific statistical issues in the design of clinical studies from preclinical through Phase 3 and 4. - CRO / Vendor Oversight: Participates in drafting request for proposal for CRO selection. Reviews and negotiates baseline budget and timelines; Guides CRO biostatistician and statistical programmers on assigned projects to ensure consistency in derived data definition, analysis files structure, analysis methodologies, and accuracy of analysis results. Ensures timely delivery of high quality deliverables. - Global Health Authority Interaction / Negotiation: Authors documents and responses submitted to Health Authorities globally with some guidance from supervisor. Represents statistics function to Health Authorities meetings as needed. - Global BDO Strategy to Improve Drug Development: Leads global BDO initiatives to improve the harmonization and efficiency of drug development which leads to cost savings with minimal supervision. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) - Master's Degree in statistics or biostatistics required - PhD in statistics or biostatistics preferred Experience Qualifications - 10+ Years of relevant experience in the pharmaceutical industry with a masters degree required - 7+ Years of relevant experience in the pharmaceutical industry with a PhD preferred Travel: Ability to travel up to 20% International travel required Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Director, Biostatistics - Oncology

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The Director, Clinical Safety, will be a product safety lead or part of a product safety team, and be responsible for overall product safety strategy or specific areas of safety surveillance and risk management, and provide safety leadership including but not limited to clinical studies, post-marketing surveillance, signal detection and management, important safety topics, and regulatory submissions. This individual will ensure proactive safety monitoring and risk management through the Safety Management Team framework. This individual will use strong leadership and communication skills to ensure effective collaboration across development functions and sites. The individual assuming this role may function as a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology, and other departments to strategically manage benefit-risk throughout the lifecycle of the drug. Specific responsibilities will vary depending on the stage of development of assigned projects (i.e., Phase I through commercialization). Responsibilities - Depending on the status of development of the compound, lead and medical-scientifically direct a team of junior physicians and scientists responsible for a compound/product safety, including project-specific training and coaching of team members and review of team output cross-functionally. - Effectively represent the CSPV on the Global Product Team or specific sub-teams such as clinical study team and submission team, providing the safety leadership and serving as the primary point of contact. - Review and analyze data from clinical trials, post-marketing and other relevant sources for the prompt identification of safety signals. Review and evaluate serious adverse event reports from clinical trials or post-marketing for completeness, accuracy, expectedness and relatedness. - Lead internal and external (especially regulatory, but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of assigned projects/products. - Define and implement strategies and action plans for identifying and managing risks throughout the product life cycle. - Effectively coordinate and manage available resources in developing and delivering high-quality safety evaluation related documents/deliverables on time. - Coordinate and participate actively in safety-related regulatory interactions (e.g., regulatory meetings, post-approval commitments). Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) - MD Board certification or eligibility required Experience Qualifications - Must have 4+ years of professional clinical safety expertise from pharmaceutical industry, regulatory agency or academia, with exposure to drug development, clinical pharmacology, and/or epidemiology. Expertise in Oncology highly preferred. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Director, Clinical Safety MD

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data Management Operations for the Data Validation and Reporting function by collaborating with internal and external stakeholders to oversee the development and delivery of clinical data programming, reporting, data visualizations, external data acquisition and validation, and tools to support project portfolio across drug programs. This role is responsible for ensuring the quality and timely delivery of programming deliverables, including integrated data review plan (IDRP), study data listings and exception reports, sample data reconciliation, external data acquisition, validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to programming standards and specifications across clinical studies. This position involves managing direct reports and/or leading multidisciplinary teams, as well as overseeing functional service providers to achieve business objectives. It requires extensive knowledge of clinical data programming, external data handling, techniques, standards, methodologies, and skills in working with internal and external systems, CROs, and vendors. Excellent verbal/written communication, analytical, organizational, and interpersonal skills are essential for effective collaboration with individuals at different levels and from diverse disciplines and cultures. Line management experience, the ability to manage and coach people, and the capability to lead multiple projects concurrently are crucial for this role. Advanced knowledge of Data Management, Biostatistics, Clinical Operations, Pharmacovigilance, handling and processing of raw data and external data, CDASH/SDTM, industry best practices, and relevant regulatory requirements is essential. This position demands significant skills in working in fast-paced environment, continuous improvement, project management, change management, and risk management. Responsibilities: Leadership, Direction, and Strategy: <ul><li>Is accountable for the management and oversight of all DM programming, reporting, and external data acquisition and validation deliverables for all studies consistent with IDRP, study data listings, exception data listings, sample reconciliation, external data acceptance and reconciliation reports, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements. Oversees the execution of external data -- acceptance, storage, and delivery activities to ensure complete, high-quality data is available for use by clinical study teams in a timely manner. Provides oversight for external data validation and quality control process for verification of the data structures in line with data transfer agreements. Manage and oversee the DM programming staff and Functional Service Provider subject matter experts at the functional level to support project portfolio milestones, and/or initiatives to achieve/exceed departmental quality/time/cost objectives.</li><li>Leads development and implementation of DM reporting strategy and solutions at the program level to achieve/exceed quality, time, and cost objectives embracing agile programming methodologies, novel approaches, and industry best practices. Drives execution of the DM programming, reporting, and data visualization activities across all studies to ensure on-time delivery of accurate and high-quality programming deliverables.</li><li>Champions and facilitates change management through providing rationales, describing improved outcomes and increased efficiencies to achieve programming operational excellence. Provides strategic input, develops tactical approaches, and proposals to advance DM Data Validation and Reporting initiatives. Leads or participates in departmental and/or multidisciplinary teams working on continuous process improvements and other initiatives. Proactively identifies and manages risks to data quality, data integrity, programming and reporting deliverables, and timelines. Collaborates with various Governance/Steering Committees, Functional Line Management, and multidisciplinary teams to develop, implement, and promote efficient programming methodologies and techniques, optimizing programs and outputs for quality, efficiency, and positively influencing daily operations.</li><li>Functions as the DM Operations Data Validation and Reporting escalation point for all programming, reporting and external data validation deliverables across all studies; proactively develops solutions within and across functions and resolves complex issues and conflicts in a timely manner. Identifies Data Validation and Reporting staffing needs, prepares annual resource projections, monitors staff utilization, participates in assessment and hiring of candidates. Performs line management duties (provides feedback, conducts formal reviews, confirms training completion, and drives career development) for direct reports, and mentors DM Operations Data Validation and Reporting staff. Directs programming representation in audits and regulatory inspections to provide relevant programming and reporting information as needed. Provides input for DM questions in health authority information requests. Builds and maintains positive business relationships with other line functions, vendors, and partners; is an ambassador and advocate for the data operations programming function with key internal and external stakeholders. Promotes Daiichi Sankyo values and quality workplace culture, collaboration in cross-functional and multicultural settings. Represents Daiichi Sankyo DM at professional conferences/meetings.</li></ul>Project Management: <ul><li>Is accountable for the completion of DM programming, reporting, external data acquisition, processing, and validation activities for drug programs under the outsourcing and in-house operating models. Is accountable for the quality, integrity, and timely delivery of all external data in line with the established data transfer agreements. Is accountable for oversight for DM Data Validation and Reporting resources, CROs, and vendors to ensure compliance with the programming standards and practices, SOPs, external/internal data standards, Good Clinical Practices (GCPs), applicable regulatory requirements, and other relevant guidelines. Accountable for inspection readiness of DM programming documentation filed/archived according to applicable Daiichi Sankyo and regulatory requirements.</li><li>Communicates with Data Operations leadership, asset leads, DM staff, and cross-functional team leads regarding goals, expectations, timelines, overall status, risks, data trends, and issues. Proactively responds to the needs of the asset leads, DM staff, and cross-functional teams and influences appropriately to ensure successful delivery of the programming deliverables aligned to business priorities. Leads prioritization and planning with the teams to ensure outcomes meet expectations.</li></ul>Functional Expertise: <ul><li>Assesses vendor Scope of Work for Data Validation and Reporting needs; engages in vendor meetings; reviews and evaluates RFPs; contributes to the proposals for contracted programming external data services; manages vendor relationships by coordinating at the governance level. Instills incorporation of industry DM programming best practices, reporting technologies, and discipline to achieve operational excellence. Accountable for adherence to DM programming standards, methodologies, data standards, and reporting technologies ensuring quality delivery of DM programming and reporting services. Provides guidance and expertise on programming of complex data listings and reports, usage of tools and technologies, data extraction mechanisms, data visualizations, and automation to advance the maturation of programming, reporting, and external data validation capabilities. Expertise in code optimization, frameworks/libraries, testing strategies, ETL/ELT capabilities, optimizing data flows, data normalization, reporting processes; data and programming standards; emerging data capabilities and methods. Implements quality-by-design approaches to confirm the quality, integrity, and fit-for-use of the external data based on appropriate and/or established data-cut-off as a pre-requisite for database lock.</li></ul>Operational Efficiency / Continuous Improvement: <ul><li>Provides leadership for operational efficiencies and productivity gains through improved programming standards, code optimization and reuse, data capabilities and methods, and automation. Challenges the status quo, encourages innovation, takes suitable risks to drive improved outcomes through agile programming methodologies, novel approaches, and technology aimed at improving quality and efficiencies. Evaluates repetitive tasks, programming errors, testing strategies, and expedites the delivery of high-quality outputs through automation. Establishes key performance indicators and continuously monitors them to detect trends and pinpoint areas for enhancements. Leads or participates in cross-functional process improvement initiatives. Maintains awareness of and disseminates information about emerging trends, best practices, data standards, clinical programming methods, techniques, and technology recommendations to enhance business capabilities, improve compliance and achieve operational efficiencies. Develops and maintains networks with thought leaders in DM and related areas.</li></ul>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education: <ul><li>Bachelor's degree in life sciences or related field required</li><li>Master's degree in life sciences or related field preferred</li></ul>Experience: <ul><li>11 or more years of experience with Bachelors (or 9 with Master's degree). Experience includes database and data validation programming and/or related work experience in a medical device, biotech, or pharmaceutical company, or similar environment (e.g., CRO); knowledge of industry standard clinical technologies, data standards, raw data handling and processing, external data acquisition, validation, reconciliation, and data visualizations/analytics experience required</li><li>5 + years managing people required</li><li>5+ managing initiatives required</li></ul>Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Director, Data Management Reporting

Join a Legacy of Innovation 110 Years and Counting! Company is committed to diversity and inclusion. We are an equal opportunity employer including veterans and people with disabilities. SummaryThrough strategic leadership, lead and manage skills and capabilities development initiatives for the Global Finance and Procurement organization and oversee project management for Finance, driving coordination, communication, and change management across various initiatives. Through a passion for capability building and strong project management skills, this role will engage with diverse stakeholders across global teams. Work closely with project teams to ensure that changes are smoothly and successfully implemented to achieve lasting benefits. Own the road map, oversight and change management of the entire portfolio of special projects. Play a key leadership role in support of all processes and procedures around change management. This role requires comfort and independence in leading complex initiatives of high dollar value from inception through to implementation and ability to handle global projects through established interactions with Japan and Europe as required. Responsibilities - Lead the Global Finance and Procurement Capability Building Program - Design a comprehensive training program for Global Functional Skills Finance, Procurement, and other functions of the Global Corporate Planning Management team. The objective is to design and manage sustainable global train-the-trainer program - Perform periodic skills gap analysis to identify areas of focus across regions and functions and set training objectives - Oversee ongoing and relevant content development and execution of the training programs. This includes coordinating across teams, identifying trainers and coaches, ensuring participants have the resources they need - Continuously assess the effectiveness of the training program through feedback and performance metrics - Collaborate with HR Learning Development to ensure the training program is current, capabilities matrix aligns with the industry trends and organizational needs, and performance management process incorporates learning and development metrics - Project Leadership and Collaboration - Support DSI Finance by managing and tracking various departmental initiatives, ensuring alignment with organizational goals. - Responsible for the development and management of ad hoc special projects as they arise - Develop and maintain processes for measuring progress, reporting outcomes, and effectively communicating updates to stakeholders. Develop the report and communication channel. - Act as the lead to coordinate and be accountable for the delivery of said projects, this includes working closely with the other team members also assigned to these projects. - Create the resourcing plan for each project and report it to the Global RD Procurement LT in a concise and clear way so that resourcing issues/constraints can be clearly managed by LT. - Lead change management efforts related to Finance initiatives, ensuring successful adoption and sustainability of new processes - Display cross-divisional leadership by enhancing reporting clarity and communication of key information among groups; Maintain strong relationship within US Finance and Procurement teams, as well as Global GCPM teams, CFO Leadership team - Lead change management efforts related to Finance initiatives, ensuring successful adoption and sustainability of new processes - Develop and implement change management strategies and plans that maximize employee adoption and minimize resistance - Conduct impact analyses, assess change readiness, and identify key stakeholders - Align on change management approach and steps with HR, Finance Procurement leadership team in the US and Globally - Engage finance procurement leadership teams in change management efforts - Establish metrics to measure the effectiveness of change initiatives. - Monitor progress and report on the status of change management efforts. - Identify and address any issues or obstacles that may arise during the change process Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) - Bachelor's Degree Business, Communications, Project Management or HR/Learning & Development (preferred areas of study) required - Master's Degree preferred Experience Qualifications - 10 or More Years Functional experience in Project Management, Business Operations, Finance, or related area required - Demonstrated success in program/project management, stakeholder engagement required - Demonstrated people leadership skills required - Experience working within global, cross-cultural environment. Japan business a plus; Bilingual a plus preferred TravelAbility to travel up to 20% Business meetings and/or conferences as necessary; Audit training programs in other regions Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Director, Finance Project Management & Capabilities Building

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: The Director, Image Analysis, Translational Pathology will work across the Precision Medicine matrix contributing to the development of digital and computational pathology strategy and implementation of digital pathology-based approaches to assessing potential predictive (patient selection) biomarkers as well as pharmacodynamic (PD) biomarkers for Oncology and Specialty Medicine programs. They will serve as a scientific expert supporting digital/computational pathology objectives including assessment of imaging technologies and platforms, algorithm development for pre-clinical, translational, and CDx use, and image analysis data generation and interpretation. They will provide expertise to create and integrate pathology datasets with broader multi-omic analyses to support hypothesis-driven translational research efforts with direct impact across the development continuum. Responsibilities:<ul><li>Provide expertise for the Translational Pathology group and lead image analysis algorithm development and decisions for digital pathology investigations performed internally and as a point of contact with external partners.</li><li>Design and lead whole-slide scanning and image storage evaluations and decisions for Translational Pathology, analyze and interpret image data, and serve as a scientific expert for the design and implementation of translational pathology plans that include digital imaging data.</li><li>Contribute to the development of company-wide computational pathology strategy and implementation through leadership of image analysis foundational platform capabilities, algorithm development and optimization, and external partnerships for biomarker discovery</li><li>Provide expertise to the Daiichi Sankyo Global Research Development organization to ensure access to state-of-the-art thinking on appropriate imaging analysis strategies, evaluating their scientific basis and clinical applicability, the validation status and any technical or statistical issues related to proposed business plans.</li></ul>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education:<ul><li>Bachelor's degree (BS) in biology, biotechnology, biomedical engineering, or related field required</li><li>PhD in biology, biotechnology, biomedical engineering, or related field or Master's degree (MS) in biology, biotechnology, biomedical engineering, or related field preferred</li></ul>Experience:<ul><li>10 or more years of digital imaging analysis, or other relevant experience with bachelor's degree OR 5 or more years of digital imaging analysis, or other relevant experience with PhD required.</li><li>Hands on experience with digital/computational pathology technologies, algorithm development, and translational research required.</li><li>Experience with image analysis software and slide scanning technologies and deep knowledge in pathology-based and other biomarker technologies including immunohistochemistry (monoplex and multiplex), digital pathology, and spatial analyses required</li><li>Experience with image analysis software and slide scanning technologies required</li><li>Experience/knowledge in companion diagnostics device development preferred</li></ul>Travel: <ul><li>Ability to travel up to 10% globally</li></ul>Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Director, Image Analysis, Translational Pathology

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: The District Manager (DM) represents Daiichi-Sankyo to assigned customers. The DM hires, leads, and manages a team of Oncology Territory Managers and is accountable for the compliant promotion of the assigned product with the assigned customers. This territory covers the following states KY, TN, SC, NC. Nature and Scope: &bull; Demonstrate Daiichi-Sankyo values, mission, and standards, and represent the company in a positive and professional manner. &bull; Reporting to the Regional Business Director, oversee the promotion of the assigned products consistent with the FDA label to assigned customers, using approved messages and resources. &bull; Build, lead, and manage a diverse team of high performing sales professionals to attain division sales goals. &bull; Develop and execute comprehensive business plans. &bull; Develop strong relationships with customers and become a trusted resource. &bull; Inform strategic business decisions through collaboration with internal stakeholders. &bull; Identify and develop talent. &bull; Foster and contribute to a positive, productive, and thriving Daiichi Sankyo culture. &bull; Ensure that all results are achieved in compliance with all company policies and practices, as well as, all applicable federal, state, and local regulations. Responsibilities: Recruits, hires, trains, retains, develops and leads diverse, high performing representatives to their full potential. <ul><li>Conducts field travel with each District Representative on a consistent basis, calling on key accounts, institutions and customers as assigned by the Company.</li><li>Completes Field Coaching Reports within 48 hours after each field ride.</li><li>Explains and pulls through incentive compensation plan designs.</li><li>Monitors District compliance of Field Sales promotional activity, ensuring appropriate reporting procedures are taking place.</li><li>Identifies and acknowledges individual strengths and needs within the District.</li><li>Maintains awareness of the development of employees within the District by working closely with employees and their Individual Development Plans.</li><li>Contributes to the talent management and succession planning processes to ensure that talent is identified and developed.</li><li>Models and exhibits strong behaviors with key customers by providing exceptional value and service.</li><li>Meet or exceed monthly, quarterly and total annual sales objectives by overseeing and managing tactical execution of brand strategies.</li></ul> Develop and execute comprehensive business plans. <ul><li>Applying knowledge of the healthcare industry, trends, applicable laws and regulations, market conditions, and the market access environment (including but not limited to pharmacy economics, payer reimbursement landscape, and patient flow/influence between academic institutions, hospitals, and community practices).</li><li>Demonstrate understanding of current or pending clinical pathways in assigned accounts, and how they influence patient treatment.</li><li>Analyze customer needs and interests, territory performance, program outcomes, and business trends; develop and execute business plans that optimize the commercial potential of our products.</li></ul> Inform strategic business decisions through collaboration with stakeholders. <ul><li>Contributes to the regional and national sales leadership teams.</li><li>Communicates frequently and collaborates with cross-functional partners.</li><li>Compliantly communicates with Medical Affairs colleagues as appropriate.</li><li>Models and leads excellence in collaboration with co-promote partners</li></ul> Meet all administrative expectations and standards, including budgets, reporting, and communication. <ul><li>Oversees maintenance of key customer target list.</li><li>Effectively manages District's budget</li><li>Models mastery of how to use reports and databases as instruments to achieve assigned goals.</li><li>Submits complete reports, on-time, and communicates matters that are relevant to the marketplace, competition to internal stakeholders.</li><li>Maintains all equipment and records in the prescribed manner.</li><li>Utilizes sales force automation system and other equipment to enhance impact of division management.</li></ul> Adheres and ensures all direct reports adhere to compliance and operating principles and expectations. Complies with applicable laws in providing healthcare providers with accurate information concerning Daiichi Sankyo, Inc.'s products. Foster and contribute to a positive, productive, and thriving Daiichi Sankyo culture. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university): <ul><li>Bachelor's Degree required</li></ul> Experience Qualifications: <ul><li>7 or More Years successful pharmaceutical experience, preferably in Sales required</li><li>4 or More Years of experience in oncology sales preferred</li><li>4 or More Years of industry sales management preferred</li><li>Experience in the oncology therapeutic area preferred</li><li>Oncology product launch experience preferred</li><li>Copromotion experience preferred</li><li>Ability to travel up to 50- 70%</li><li>Must have a valid driver's license with a driving record that meets company requirements</li><li>Compensation and seniority level/title based on experience and qualifications</li></ul> Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

District Manager, Oncology Breast - Carolinas

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: The District Manager (DM) represents Daiichi-Sankyo to assigned customers. The DM hires, leads, and manages a team of Oncology Territory Managers and is accountable for the compliant promotion of the assigned product with the assigned customers. This territory covers the following states NJ and Metro NY. Nature and Scope: &bull; Demonstrate Daiichi-Sankyo values, mission, and standards, and represent the company in a positive and professional manner. &bull; Reporting to the Regional Business Director, oversee the promotion of the assigned products consistent with the FDA label to assigned customers, using approved messages and resources. &bull; Build, lead, and manage a diverse team of high performing sales professionals to attain division sales goals. &bull; Develop and execute comprehensive business plans. &bull; Develop strong relationships with customers and become a trusted resource. &bull; Inform strategic business decisions through collaboration with internal stakeholders. &bull; Identify and develop talent. &bull; Foster and contribute to a positive, productive, and thriving Daiichi Sankyo culture. &bull; Ensure that all results are achieved in compliance with all company policies and practices, as well as, all applicable federal, state, and local regulations. Responsibilities: Recruits, hires, trains, retains, develops and leads diverse, high performing representatives to their full potential. <ul><li>Conducts field travel with each District Representative on a consistent basis, calling on key accounts, institutions and customers as assigned by the Company.</li><li>Completes Field Coaching Reports within 48 hours after each field ride.</li><li>Explains and pulls through incentive compensation plan designs.</li><li>Monitors District compliance of Field Sales promotional activity, ensuring appropriate reporting procedures are taking place.</li><li>Identifies and acknowledges individual strengths and needs within the District.</li><li>Maintains awareness of the development of employees within the District by working closely with employees and their Individual Development Plans.</li><li>Contributes to the talent management and succession planning processes to ensure that talent is identified and developed.</li><li>Models and exhibits strong behaviors with key customers by providing exceptional value and service.</li><li>Meet or exceed monthly, quarterly and total annual sales objectives by overseeing and managing tactical execution of brand strategies.</li></ul> Develop and execute comprehensive business plans. <ul><li>Applying knowledge of the healthcare industry, trends, applicable laws and regulations, market conditions, and the market access environment (including but not limited to pharmacy economics, payer reimbursement landscape, and patient flow/influence between academic institutions, hospitals, and community practices).</li><li>Demonstrate understanding of current or pending clinical pathways in assigned accounts, and how they influence patient treatment.</li><li>Analyze customer needs and interests, territory performance, program outcomes, and business trends; develop and execute business plans that optimize the commercial potential of our products.</li></ul> Inform strategic business decisions through collaboration with stakeholders. <ul><li>Contributes to the regional and national sales leadership teams.</li><li>Communicates frequently and collaborates with cross-functional partners.</li><li>Compliantly communicates with Medical Affairs colleagues as appropriate.</li><li>Models and leads excellence in collaboration with co-promote partners</li></ul> Meet all administrative expectations and standards, including budgets, reporting, and communication. <ul><li>Oversees maintenance of key customer target list.</li><li>Effectively manages District's budget</li><li>Models mastery of how to use reports and databases as instruments to achieve assigned goals.</li><li>Submits complete reports, on-time, and communicates matters that are relevant to the marketplace, competition to internal stakeholders.</li><li>Maintains all equipment and records in the prescribed manner.</li><li>Utilizes sales force automation system and other equipment to enhance impact of division management.</li></ul> Adheres and ensures all direct reports adhere to compliance and operating principles and expectations. Complies with applicable laws in providing healthcare providers with accurate information concerning Daiichi Sankyo, Inc.'s products. Foster and contribute to a positive, productive, and thriving Daiichi Sankyo culture. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university): <ul><li>Bachelor's Degree required</li></ul> Experience Qualifications: <ul><li>7 or More Years successful pharmaceutical experience, preferably in Sales required</li><li>4 or More Years of experience in oncology sales preferred</li><li>4 or More Years of industry sales management preferred</li><li>Experience in the oncology therapeutic area preferred</li><li>Oncology product launch experience preferred</li><li>Copromotion experience preferred</li><li>Ability to travel up to 50- 70%</li><li>Must have a valid driver's license with a driving record that meets company requirements</li><li>Compensation and seniority level/title based on experience and qualifications</li></ul>In compliance with pay transparency laws, the targeted base salary range for this position is $190,000 - $230,000. Please note, actual Compensation and seniority level/title will be determined based on experience and qualifications. Additionally, this position will be eligible for sales incentive and long term incentive based on performance. This position is also eligible for a company vehicle. Our benefits are part of what makes Daiichi Sankyo, Inc. a great place to work. We are proud of our longstanding commitment to the health and well-being of our employees and their families. We provide comprehensive health care benefits at a reasonable cost that are highly competitive in the pharmaceutical industry, as well as a Savings & Retirement Plan that includes a competitive company match plus retirement account deposits. To learn more about our benefits, please view the following link: https://careers.dsi.com/en-US/page/benefits Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

District Manager, Oncology Breast - Metro NY/NJ

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: The TA Oncology Strategy and Execution Lead is a pivotal leadership role responsible for driving the strategic and operational effectiveness of this newly formed TA Oncology organization. This position will report to the Global Head of Late-Stage Oncology Development. This individual will play a central role in supporting the Global Head of Late-Stage Oncology Development in the formation and management of the newly created TA Oncology Leadership team and in driving strategy, management and facilitation of key programs and initiatives, ensuring alignment of strategic priorities, resources allocation and capability elevation. As an integral member of the Leadership team, the position will closely collaborate with key stakeholders and leaders across the R&D organization to achieve desired business results, optimize ways of working and enhance overall functional excellence across the newly formed TA Oncology organization The incumbent will be expected to independently lead cross functional initiatives intended to build capabilities, improve processes, and foster collaboration and connectivity to enhance the operational efficiency of the TA Oncology organization. Such initiatives may be conducted or coordinated in partnership with members of the RD Operations organization or with the functional excellence teams of functions within the TA Oncology organization. The individual may also support, or lead initiatives intended to expand the Daiichi Sankyo global development footprint or to promote globalization. The incumbent will also have direct accountability for administrative deliverables and will be responsible for coordinating resource management of the TA Oncology organization with chiefs of staff of functions within the organization. In the addition, the individual will help plan the transition of asset programs from early to late-stage development in coordination with the Early-Stage Oncology Development organization and other functions within global R&D. The position will also be expected to provide guidance and mentorship to the chiefs of staff of functions within the TA Oncology organization as well as to build processes intended to optimize the communication flow within the functions of the organization. Responsibilities:<ul><li>Strategic integration functional excellence: Build a thorough understanding of all core business functions within the TA Oncology organization and apply that knowledge to effectively manage strategic and tactical initiatives under the guidance of the TA Leadership team and in partnership with members of the RD Operations organization or with the functional excellence teams of functions within the TA Oncology organization. Serve as a trusted partner to the Head of Late-Stage Oncology Development, providing insights and recommendations on functional priorities and challenges, and support the Head in leadership and execution of programs and initiatives that will help shape and drive late-stage strategy and operational delivery.</li><li>Proactively identify issues that could impact the successful execution of TA Oncology business objectives; escalation of such issues to the Global Head of Late-Stage Oncology Development while proactively formulating plans to address the concerns and mitigate associated risks; Accountability for day-to-day Late-Stage Oncology business operations as decided by the Global Head of Late-Stage Oncology Development.</li><li>Program Asset Transition Leadership: Coordinate resource management for the TA Oncology organization with chiefs of staff of functions within the organization. In the addition, proactively plan for the transition of asset programs from early to late-stage development in coordination with the Early-Stage Oncology Development organization and other functions within global RD, address potential challenges and optimize transition strategies</li><li>Executive Advisory Communications: provide strategic insights and deliver concise updates on project statuses and next steps to prepare the Head of Late Stage Oncology Development for upcoming discussions, commitments, and meetings; Prepare presentation documents, speaker notes and memos for meetings, conferences and other venues as needed; Act as representative for the Head of Late Stage Oncology Development in appropriate meetings to gather information, provide input and facilitate efficient decision making</li><li>In conjunction with finance and Project Management support the Head of Oncology Late-Stage Development in management of budget, capacity, resources and preparation of associated reports</li><li>Prepare communications on behalf of the Global Head of Late-Stage Oncology Development for stakeholders of all levels both internally and externally</li></ul>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education:<ul><li>Master's Degree Advanced degree in a scientific discipline required and</li><li>PharmD preferred or</li><li>PhD preferred or</li><li>MD preferred</li></ul>Experience:<ul><li>10 or More Years of prior experience in project management or similar functional experience within the biotech/pharmaceutical industry required and</li><li>Demonstrated understanding of the clinical research process and oncology drug development required and</li><li>Demonstrated track-record of complex decision making, communication and collaboration skills with proven cross-functional and multi-level relationship building and stakeholder management skills Experience with workforce planning and managing operating budgets with varying degrees of complexity Strategic and analytical abilities, diplomacy, negotiation and excellent oral and written communications skills. Ability to influence internal and external stakeholder groups Experience operating in a matrix environment required</li></ul>Travel:<ul><li>Ability to travel up to 10%</li></ul>Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Executive Director, TA Oncology Strategy and Execution Lead

Join a Legacy of Innovation - 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Accountable for supporting and managing the Quality Management System (QMS) in accordance with regulatory requirements and ensuring adherence to the Quality Manual. Responsible for ensuring efficiency, accuracy, and standardization in document management and data integrity. The incumbent is responsible for authoring, reviewing, and managing the development of internal procedures to ensure compliance with global and harmonized Quality Standards and regulatory requirements for the GMP area. Additional responsibilities include:<ul><li>Creating and reviewing Quality Assurance Agreements with contract organizations</li><li>Managing a Quality Assurance Agreement system to oversee vendor qualification programs</li><li>Evaluating critical operations data for Annual Product Reviews</li><li>Overseeing the stability studies program for drug products marketed in and exported from the US</li></ul>Responsibilities Quality Assurance Agreements<ul><li>Manage a comprehensive system for establishing local and global Quality Assurance Agreements</li><li>Ensure all external contractors involved in manufacturing and testing meet GMP compliance</li><li>Support stable and quality supply in line with local and international regulations</li><li>Proactively plan and complete QA Agreement reviews in a timely manner</li></ul>Change Control System<ul><li>Oversee an effective Change Control System to capture and manage proposed changes</li><li>Ensure timely communication with internal and external partners</li><li>Strategically address changes to minimize impact on commercial and investigational product availability</li></ul>CAPA Management<ul><li>Ensure oversight of CAPA Management activities</li><li>Communicate promptly with internal and external stakeholders</li><li>Monitor and enforce CAPA completion deadlines per internal procedures</li></ul>Product Data Management<ul><li>Collect and evaluate critical manufacturing data</li><li>Author Annual Product Reviews</li><li>Track complaints, deviations, and change controls</li><li>Create trend evaluations to maintain high quality standards</li><li>Oversee the stability studies program in coordination with contract testing laboratories</li></ul>Quality Metrics<ul><li>Collect and analyze data on deviations, CAPA, Change Controls, OOS, and audits</li><li>Report Quality Metrics periodically to Senior Management</li><li>Identify potential quality issues and propose solutions</li></ul>Development of Standards, Procedures (SOPs), and Training<ul><li>Liaise with GMP areas to ensure procedural compliance</li><li>Implement global/regional QA GMP Standards and Procedures</li><li>Support SOP authoring and review processes</li><li>Provide training on QA System Management processes</li></ul>Cross-Functional Team Participation<ul><li>Collaborate with local and global functions for process alignment</li><li>Ensure regulatory compliance and best practices</li><li>Align cross-functional processes for global standardization</li></ul>Qualifications Successful candidates will be able to meet the qualifications below with or without reasonable accommodation. Education Qualifications<ul><li>Bachelor's Degree in a scientific discipline</li><li>Master's Degree or other advanced degree - Preferred</li></ul>Experience Qualifications<ul><li>Must have 4 or more years in professional pharmaceutical, biological operations experience, including drug manufacturing, packaging, QA, compliance, and auditing</li><li>Demonstrated knowledge working within various pharmaceutical dosage forms</li><li>Knowledge of multinational drug regulations</li><li>Proven understanding of quality management and continuous process improvement</li><li>Previous management experience would be a plus</li></ul>Travel<ul><li>Ability to travel up to 10%, including overnight travel</li></ul>Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Manager QA Systems Management

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: The Manager, CTBO provides support to facilitate effective functioning in the following areas 1) GCO LT Forum(s) that focus on systemic aspects of performance and delivery of global clinical operations. 2) GCO capacity demand and supply & resourcing strategies 3) GCO metrics & dashboards 4) GCO technology needs 5) GCO financial processes The role is part of the Clinical Trial Business Operations (CTBO) group in Global Clinical Operations (GCO). Depending on business needs, the position may also assist CTBO and GCO on several business operations efforts and initiatives in addition to the stated areas above to meet GCO goals and vision. The position requires a strong mix of core clinical research operations knowledge and associated business processes and analytical acumen. Responsibilities:<ul><li>Oversee and facilitate GCO Leadership Forum(s)a) Support, in collaboration with the Head of PD, the successful planning, organization and delivery of intended goals of the PD meetings.) Lead, support and facilitate the Performance and Delivery (PD) Forum) Coordinate with relevant CTBO and GCO LT members effective planning and preparation of presentation materials including agendas for the PD Forum.) Identify key stakeholders (internal and external to GCO) and effectively collaborate and engage them to identify, communicate, prepare materials for PD forum discussions to resolve issues risks) Document and communicate key issues risks and outcomes of PD forum to internal and external to GCO stakeholders including other cross functional sr. leadership teams and forums) Support influencing the shift in mindset to foster transparency in communication of risks and issues, and collaboration for solutioning across GCO and cross functional leadership in support of meeting performance and delivery goals of global clinical operations</li><li>Support GCO Capacity Demand and Supply Resourcing Strategies) Support efforts to understand current and future capacity demand and supply needs of the GCO department spanning various delivery models (CRO or in sourced) via analyses.) Deliver standard and ad-hoc reports and analyses (in collaboration with PD organization) to help understand the book of work, resource capacity utilization, and GCO resourcing strategy.</li><li>Support adoption and refinement of GCO Metrics, Dashboards, and IT Needs) Scrutinize and help support the identification, consolidation, and oversight of GCO's overall needs on metrics and technology and acting as GCO's point of contact with MARS and DS IT related groups for annual IT portfolio prioritization and planning. Liaise with internal GCO functions including Functional Excellence team as needed.) Support identification, creation and business adoption of appropriate consistent metrics, targets, and key performance indicators (KPIs) that assess GCO's overall health. Collaborate with all applicable GCO and non GCO functions including but not limited to GCO Functional Excellence, Strategic Vendor Oversight, Feasibility and DS Data Governance functions.) Liaise and partner closely with MARS and/or applicable DS IT team(s) as a GCO business partner on metrics/analytics technology needs for PD Forum.) In collaboration with other CTBO staff (as appropriate), generate ad-hoc analyses to support identification and implementation of innovative approaches to efficient delivery clinical study and programs.</li><li>Support GCO Financial Processes Liaise and collaborate with Finance and GCO functional heads to provide real-time tracking of departmental budget vs. spend, and highlight needs and gaps to support GCO resourcing strategies and goals, invoicing processes, and process level changes based on the evolving environment (e.g., country regulatory requirements).</li></ul>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education:<ul><li>Bachelor's Degree Bachelor's degree in Life Sciences and a minimum of 5 years' experience in pharmaceuticals or biotechnology drug development (master's degree with 3 years' experience) required</li></ul>Experience:<ul><li>4 or More Years Knowledge of ICH/GCP and regulatory guidelines/directives required</li><li>5 years of clinical research operations experience preferred preferred</li><li>Ability to work independently as well as collaboratively in a global, cross-functional and matrix environment required</li><li>Strong written and verbal communication skill required</li><li>Strong statistical modeling experience, and analytical and database related skills. required</li><li>Effectively negotiates and influences to solve high impact/scope challenges required</li><li>Strong leadership and facilitation skills required</li><li>Strong team management skills; Leads and influences the team; effectively manages functional or direct reports preferred</li><li>Good understanding of the concepts and applications of clinical research, medical terminology and other disciplines involved in drug development preferred</li><li>Proficiency in computer applications such as Microsoft Word, Excel, and PowerPoint required</li></ul>Travel:<ul><li>Ability to travel up to 20% In house position that may require travel (global)</li></ul>Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Manager, CTBO Performance & Delivery

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary<ul><li>This position supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product Lead, Product Safety Lead (PSL), Clinical Safety Physician(s), and cross-functional team(s) in support of benefit-risk profile throughout the product lifecycle.</li><li>Independently leads activities without supervision for assigned clinical studies.</li><li>Lead activities under the direction of Clinical Safety Scientist Product Lead.</li><li>Develop expertise in one or more focus areas (SME).</li><li>Involved in audits/inspections for safety surveillance and risk management for assigned clinical studies through inspection readiness preparation.</li></ul>Responsibilities Risk Management (Signal Identification, Evaluation, Mitigation)<ul><li>Supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product Lead, PSL, Clinical Safety Physician(s), and cross-functional team(s).</li><li>Collaborates with Clinical Safety Scientist Lead and PSL or Clinical Safety Physician(s) to evaluate safety data of any source to identify potential safety signals, track safety signals in the global electronic signal tracking tool, and perform safety analysis/evaluation.</li><li>May contribute to safety action recommendations, communication, and risk minimization plans. Presents assessments to appropriate forums, including the Safety Management Team (SMT) or other cross-functional teams.</li><li>Collaborates with Clinical Safety Scientist Lead and PSL to develop materials (presentations, safety analyses/evaluations, etc.) for SMT/Product-level safety meetings.</li><li>Collaborates with Clinical Safety Scientist Product Lead and PSL to develop minimum core product safety requirements for inclusion in Clinical Study Protocols (CSPs) and Informed Consent Forms (ICFs).</li><li>Collaborates with Clinical Safety Scientist Product Lead and PSL to develop the Safety Management Plan for assigned product.</li></ul>Safety Communication<ul><li>Collaborates with Clinical Safety Physician(s) for assigned clinical studies to review and revise CSPs, ICFs, Clinical Study Reports (CSRs), and review Statistical Analysis Plans (SAPs) and statistical outputs (tables, figures, and listings [TFLs]), and other clinical study documents.</li><li>Collaborates with Clinical Safety Scientist Lead and PSL to author safety sections of the Investigator's Brochure, aggregate reports (DSUR/PLL), prescribing information, Company Core Data Sheet (CCDS), Risk Management Plans (RMPs).</li><li>Contributes to regulatory authority requests or communication for assigned clinical studies.</li></ul>CTD Submissions / Other<ul><li>May support Common Technical Document (CTD) submissions by collaborating with Clinical Safety Scientist Lead, Clinical Safety Physician(s), PSL, and cross-functional team to develop safety strategy, key safety messages, and review/author safety sections of CTD.</li><li>Develops expertise in one or more focus areas.</li><li>Supports Data Monitoring Committees (DMCs) and due diligence activities for assigned product(s), as needed.</li><li>Involved in audits/inspections for safety surveillance and risk management for assigned clinical studies through inspection readiness preparation.</li></ul>Project Management<ul><li>Coordinates SMT/Product-level safety meetings, maintains roster, calendar, and minutes, and communicates materials in support of the Clinical Safety Scientist Product Lead and PSL.</li><li>May serve as a project manager for other activities involving assigned product(s) or clinical studies, as needed.</li></ul>Qualifications Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)<ul><li>Bachelor's Degree (minimum required)</li><li>PharmD preferred</li><li>PhD preferred</li></ul>Experience Qualifications<ul><li>Possesses scientific or therapeutic area and drug development knowledge (preferred).</li><li>0-1 year of experience with an advanced degree required.</li><li>2-3 years of experience with a Bachelor's degree required.</li></ul>Travel<ul><li>Ability to travel up to 10%</li></ul>Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Manager, Clinical Safety Scientist

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. . Summary: The purpose of this job is to oversee statistical vendor deliverables, perform programmatic review of analysis datasets and Table, Listing, and Figures (TLFs) generated by vendor, ensure deliverable quality, and expedite the preparation of oncology compound regulatory submission. It will also maintain institutional knowledge across oncology compounds and support building up oncology programming standard on datasets and TFLs to improve efficiency and quality. Responsibilities: - By leading internal programming contractor or by self, perform programmatic review of analysis datasets and TLFs generated by statistical vendor, ensure deliverable quality for the pivotal studies, Integrated Summary of Efficacy (ISE)/Integrated Summary of Safety (ISS) for oncology submission compounds, and expedite the preparation of regulatory submissions. Responsibilities include: review Case Report Form (CRF) annotation and Study Date Tabulation Model (SDTM) dataset, identify data inconsistencies and support data review, review analysis dataset specifications and ensure correct interpretation of SAP, develop independent programs to validate analysis dataset and TLFs generated by vendor, ensure analysis dataset in compliance with CDISC and submission requirement, review submission data package and ensure its quality and integrity - Oversee statistical programming vendor on project planning and execution to ensure high quality deliverables and timelines met. Responsibilities include: review and agree on vendor project timelines and resource planning, work in tandem with Biostatistics and Data Management members to ensure best vendor performance, monitor analysis dataset and TLFs transfers for ongoing and complete trials, confirm data use and output quality, proactively ensure the resolution of programming related issues prior to database lock analysis, be accountable and verify completeness of study programming deliverables, maintain all required study programming documentation required for Trial Master File (TMF) - Maintain institutional knowledge across oncology compounds and support building up oncology programming standard on datasets and TFLs to improve efficiency and quality. Responsibilities include: contribute to CRF and SDTM standard development, support develop, implement, and maintain Analysis Data Model (ADaM) dataset and TLF standard, develop sample programs to generate standard ADaM dataset and TLFs, support training and ensure implementation of ADaM and TLFs standard in clinical trials analysis - Provide programming support to prepare regulatory requested analyses and help submission team in quick turnaround in response to regulatory agencies. Responsibilities include: create TLFs to support submission QAs in a quick turnaround, support ad-hoc and exploratory analysis requested by clinical team, provide programming supports in agency response or potential Advisory Committee Meeting - Develop and maintain programming macros to effectively support internal data review and monitoring. Responsibilities include: work with Biostatistics member to define the requirements of efficacy data review, develop macros and support the internal data review and monitoring on an ongoing basis Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) - Master's Degree Biostatistics or similar degree required - PhD Biostatistics or similar degree preferred Experience Qualifications - 6+ Years of proven experience within pharmaceutical industry, or CROs supporting statistical analysis of clinical trials programming with a masters degree required - 3+ Years of proven experience within pharmaceutical industry, or CROs supporting statistical analysis of clinical trials programming with a PhD preferred - Advanced working knowledge of all aspects of the SAS programming language used in clinical trials programming. preferred - Advanced working knowledge of CDISC SDTM and ADaM, and extensive experiences of their implementation in clinical trials analysis preferred - Advanced understanding of statistical concepts in support of analyses and reporting of clinical trials. preferred - Having knowledge of all phases of drug development, including early and late phase clinical development and submission preferred - Having solid background of applied statistics preferred - Solid knowledge of new advanced statistical methods using SAS preferred - Knowledge in database structures and set-up preferred - The candidate should have successfully provided programming expertise at the Project level for at least two global development projects that have been submitted to regulatory agencies preferred Travel: Ability to travel up to 10% Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Manager, Statistical Programming

Join a Legacy of Innovation - 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary This role is responsible for partnering with DS internal senior stakeholders to lead, assess, develop, negotiate, and execute strategic sourcing activities (both U.S. and Global) from RFP through to contract execution. Leads all aspects of strategic sourcing to ensure best value (cost, quality, Account Mgmt, timelines) for the businesses. Performs in-depth bid analysis and complex negotiations for efficiencies. Harnesses enterprise-wide knowledge and perspective coupled with in-depth functional knowledge to process, analyze, and prioritize value options that optimally benefit the stakeholders, DSI, and DS Group. Develops comprehensive global category management strategies to uncover strategic insights to help influence and inform Business decisions. Proactively seeks out and recommends new process improvements to optimize and enhance efficiencies and ways of working. Takes ownership and project manages a high volume of high-level projects which involves working with suppliers and internal stakeholders to define scope and review of work orders and agreements. Mitigates supplier issues and develops action plans to resolution. Leads supplier relationship management to ensure suppliers are meeting expected performance levels and driving innovative ideas for potential Brand application. Responsibilities<ul><li>Leads all strategic sourcing efforts from vendor assessment, RFP, negotiation, award, and contracting with senior business stakeholders for DS products and alliances.</li><li>Develops comprehensive global category management strategies which involves in-depth spend analysis, identifying opportunities, key insights, marketplace intelligence, and trends, to help inform Business budgeting and supplier utilization decisions.</li><li>Partners with senior business stakeholders across functions to understand business objectives and create annual plans to align objectives with sourcing strategies and solutions to achieve optimal results. Ensure that procurement policies and methodologies are understood and utilized. Serve as the lead relationship manager" to deliver best practices to the business partners.</li><li>Leads supplier relationship management to ensure supplier performance meets expected services levels and drives and enables innovation for potential Brand application, and continuous improvement.</li><li>Leads complex bid analysis, commercial contract negotiations, and execution, partnering closely with internal stakeholders such as Marketing, Legal and IT etc.</li><li>Ensures contracts include the appropriate terms and conditions for cost, quality, payment terms, timelines, and mitigates any risk; while ensuring all contracts are executed in accordance with company policies.</li><li>Develops and executes risk management strategies designed to protect DSI and DS Group and assure continued supply of goods and services.</li><li>Accountable for delivering cost reduction and value-added benefits to meet annual department and Business savings targets. Measure savings/value delivered to the business by utilizing an approved global savings calculation methodology savings tracking tool which includes both cost reduction and cost avoidance.</li><li>Proactively seeks out and identifies new areas of opportunity to drive additional sourcing value as well as identify, evaluate, and recommend best-in-class processes and tools.</li><li>Works closely with Procurement Operations to integrate the Small Business Administration plan and P2P continuous improvement into all sourcing activities.</li><li>Demonstrates thorough understanding of procurement processes/procedures, business, and legal language in contracts and supplier management.</li><li>Develops strong relationships with preferred suppliers. Actively manage preferred supply base for assigned categories and reinforce compliance.</li></ul>Qualifications Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)<ul><li>Bachelor's Degree required</li><li>MBA and/or Certified Professional in Supply Management (C.P.S.M) highly desired</li></ul>Experience Qualifications<ul><li>5 years strategic sourcing experience required</li><li>Experience in strategic sourcing, supplier management, and contract management required</li><li>Indirect procurement and pharma experience is preferred</li><li>Experience working with an e-Procurement tool is preferred</li><li> Experience leading and participating on cross-functional and/or global teams required</li><li> Internal stakeholder management, category management, process and continuous improvement expertise, project management and supplier performance measurement skills is required</li><li> Procurement process knowledge, contract management, financial analysis, market analysis, supplier analysis, supplier management, supplier diversity is required</li><li> Marketing Procurement experience in the pharmaceutical industry including but not limited to Creative Agencies, Media Planning and Buying, Market Access, Market Research, and Patient Assistance Programs. Is Preferred</li></ul>Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Manager, Strategic Sourcing

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary The Study Associate Manager , under the guidance of the Associate Director, will supervise a group of Study Associates (SAs) or Senior SAs who assist in planning and in the execution of clinical studies in adherence to the protocol, Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The SA Manager will ensure the SAs provide clinical administrative support to the study teams and support interactions with the Contract Research Organizations (CROs) and other vendors conducting the study to help monitor compliance with Quality Oversight measures. Responsible for staff training, performance management, setting individual employee goals and career growth opportunities. The SA Manager will also manage contract staff, as required. Responsibilities: <ul><li>Supervise at team of 10-12 Study Associates</li><li>Participate in resume review, interviewing, hiring and onboarding of new staff</li><li>As part of Vendor Oversight, meet with contract agencies on a monthly basis to provide performance feedback for contract Study Associates, contract statuses, and discuss project timelines for current and future contract needs</li><li>Evaluate employee performance through study team feedback and established performance metrics, and provide this feedback through regularly scheduled 1:1 meetings</li><li>Collaborate with Clinical Study Manager on SA deliverables</li><li>Participates in departmental and cross-functional process improvement initiatives, as required.</li><li>In-house office position that may require occasional travel. </li></ul>Qualifications: Education Bachelor's degree required. Master's degree is preferred Experience <ul><li>5 years relevant experience is required with a BS; 3 years relevant experience with an MS</li><li>1-2 years of people management is required.</li></ul>Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization (CRO). CRA experience is preferred. Competencies Advanced oral and written communication skills. Identifies and resolves problems and escalates issues appropriately Demonstrates advanced knowledge of processes related to clinical studies, regulatory issues, CRO operations, and compliance practices Interacts appropriately with internal and external stakeholders (e.g., CROs and other team members). Effectively manages information, data, related analyses, forms and reports Effectively multi-tasks different assignments and responsibilities. Proficient with medical terminology. Working skills in computer applications, such as Microsoft Word, Excel, PowerPoint, and Outlook. Travel:<ul><li>In-house office position that may require occasional travel. 10% of Time</li></ul>Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Manager, Study Associates

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Through leadership and management of supply planners and processes, responsible for ensuring that inventory is at or near target levels by managing the day-to-day relationship with Contract Management Organizations (CMO's), internal DS plants and DSI's Forecasting Team. Analyzes forecast against current inventory to provide required supply forecasts , creates Purchase Orders (PO's) and ensures that CMO's and internal DS plants are meeting DSI supply needs across the entire product portfolio. Responsibilities<ul><li>Manage the development of all packaging plans for CMO's based on forecast and current inventory levels across all product portfolios. Manage the creation of production plans for finished goods. Analyze inventory trends and procure bulk drugs and finished goods. Coordinate efforts with CMO partners throughout the supply chain to achieve inventory plans. Manage supply planners (if applicable) to actively monitor inventory levels for packaged products, all materials, and production schedules. Manages month end financial close out. Communicates and elevates concerns with CMO performance if needed. Own the reporting and overseeing of all product metrics. Manages the operational activities required for import/export of products and materials coming from/going to locations outside of the USA.</li><li>Execute the processes for data collection and analysis for the department and for Global requests. Support the data collection for the Sales and Operations Planning (SOP) process.</li><li>Execute the processes required to update information regarding purchase and process order status, by coordinating cross-functional activities with Finance, Manufacturing, Sourcing, Inventory Control and Shipping/Receiving. Ensures that systems and software [SAP: Material Requirements Planning (MRP), Purchase Order Management, Inventory Management] are in place and up to date, to generate orders and to track and maintain inventory. Oversee operational activities to ensure systems and processes used in Supply Planning are functioning appropriately.</li></ul>Qualifications Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university): <ul><li>Bachelor's Degree required; a degree in Business, Logistics or related field preferred</li></ul> Experience Qualifications: <ul><li>4 or More Years overall related experience required</li><li>1 or More Years of experience in production planning and/or materials management required</li><li>1 or More Years of experience using an ERP system (preferably SAP) in the Supply Planning area required</li><li>4 or More Years of experience in production planning and/or materials management preferred</li><li>1 or More Years of knowledge of FDA requirements preferred</li><li>Ability to travel up to 20% Primary travel to domestic contract manufacturing locations and to global DS sites as required.</li></ul> Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Manager, Supply Chain Planning

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: This is a remote, field-based role that can be done from anywhere in the upper Midwest Region (Chicago, Minneapolis, Madison, etc). As a member of the U.S. Medical Field Medical Affairs team, the Medical Value Liaison provides scientific and health economics/outcomes research support for DSI initiatives and shares insights on DSI products and portfolio proactively and upon request with customers across various U.S. healthcare segments. Additionally, the Medical Value Liaison will demonstrate senior-level leadership at Daiichi Sankyo (DSI) through innovation, strategic foresight, and the ability to anticipate trends and capitalize on emerging opportunities. Responsibilities:<ul><li>Deliver scientific and pharmacoeconomic data on Daiichi Sankyo products to healthcare decision-makers responsible for managing medical care across various settings, including community oncology groups, hospital/IDN systems, academic medical centers, managed care organizations, pharmacy benefit management companies, payer groups, and company-sponsored advisory board meetings.</li><li>Identify and communicate scientific, clinical, health outcomes, and pharmacoeconomic research insights and objectives from healthcare decision-makers to appropriate Daiichi Sankyo colleagues.</li><li>Collaborate with Market Access and Medical Scientific Liaisons to address the scientific, clinical, therapeutic, and product-related informational needs of healthcare decision-makers and HCPs.</li><li>Partner with internal Care Team members to ensure a coordinated, strategic approach to supporting healthcare decision-makers and optimizing patient outcomes.</li><li>Develop expertise in evidence-based medicine and demonstrate leadership by shaping discussions with key internal and external stakeholders, ensuring the Daiichi Sankyo's perspective is represented in credible publications.</li><li>Build and cultivate direct relationships with key opinion leaders and payer influencers in both clinical practice and academia to discuss therapeutic areas relevant to Daiichi Sankyo.</li><li>Coordinate scientific presentations and communications within the assigned geographical area, facilitating exchanges between healthcare system decision-makers and Daiichi Sankyo colleagues.</li><li>Attend select scientific meetings and professional conferences to stay informed, present health outcomes research and pharmacoeconomic data as appropriate, and engage in scientific exchange with value-based decision-makers.</li><li>Gather customer insights to inform medical and commercial decision-making.</li><li>Strengthen relationships with internal stakeholders by anticipating trends and identifying strategic opportunities.</li><li>Support leadership in developing and executing the FMA department strategy in alignment with Medical, Market Access, and Brand strategies, while actively participating in Medical Affairs and FMA strategic planning processes.</li><li>Develop the ability to lead national-level projects and initiatives by aligning cross-functional teams and gaining organizational support.</li><li>Complete administrative responsibilities, including monthly expense and field activity reporting.</li><li>Develop the capability to fully represent FMA leadership at Daiichi Sankyo meetings, functions, and events.</li></ul>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: PharmD, M.D., or Ph.D in a health sciences related field required; Master's in pharmaco-epidemiology, epidemiology, or health economics preferred Principal Medical Value Liaison must have: 4 or more years of experience including medical & scientific affairs, clinical practice, research, academic or US managed markets required with a minimum of 4 years in the pharmaceutical industry preferred. Additional expertise must include 1-year of experience as a Principal Medical Value Liaison or related experience required. Senior Medical Value Liaison must have: 4 or more years of experience including medical & scientific affairs, clinical practice, research, academic or US managed markets required with a minimum of 3 years in the pharmaceutical industry preferred. Additional expertise must include 1-year of experience as a Sr. Medical Value Liaison or related experience required. Previous experience in oncology, pharmaco-economics, health outcomes research, disease management principles and tools, and evidence based medicine is preferred. Must have a valid driver's license with a driving record that meets company requirements. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Principal Medical Value Liaison - Midwest, Field Medical Affairs, USMA

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary US Medical Affairs leader for assigned compound under the supervision and leadership of the Executive Director of Medical Research and Strategy, US Medical Affairs (USMA). Develops the USMA strategy and tactical plan as part of the US Brand Strategic Plan and leads the execution of the activities in the USMA plan including Launch Readiness and Life Cycle Management. Leads the team for this compound. Responsibilities - Responsible for the development of the USMA strategy and medical objectives for the assigned compound and leads development and execution of the US Medical Affairs plan and budget management including activities related to evidence generation, scientific engagement and communication as part of Launch Readiness activities and life cycle management from a medical perspective - Participates in Global Medical Affairs committees as requested. Serves as US Medical Affairs Lead, to gain strategic and planning alignment across the matrix team and the core USMA functions. Represents US medical affairs function as a member of the various cross-functional forums including, Publications Planning, Clinical and Safety sub-teams, US and Global Brand Team, and US Product Team to inform clinical development, commercialization, market access, and other cross-functional strategic discussions. - Provides medical leadership: Leads USMA teams as part of evidence generation forums and study teams for Local/Regional Medical Affairs company sponsored study concepts as needed. Partners with RWE and HEOR strategy and Biomarker/CDx leads on related integrated evidence generation strategies and activities as part of the USMA Plan. Provides medical review of expanded access programs (EAP) and, investigator-initiated studies (IIS) as part of a US IIS Review Committee, for assigned compound. Collaborates with Global Medical Affairs and across USMA functions to develop, review, and align on key scientific communications and medical information response documents within legal and compliance regulations. Leads internal stakeholder medical education activities related to the compound data. In partnership with Medical Intelligence and Congress Planning leads, communicates and educates on related competitor data. Provides medical leadership in scientific engagement activities with key external stakeholders such as advisory boards, investigator interactions, congress activities, peer to peer discussions with key thought leaders. Provides medical support for scientific symposium and medical congresses within legal and compliance regulations.oWorks with Patient Advocacy leads and Grants office to incorporate the patient voice and define external medical education strategies for independent grants, respectively.oProvides input into publication strategy, data gap analysis, and tactical planning as part of the overall USMA plan. Reviews and approves abstracts, manuscripts, and other data disclosure documents. - Attract and develop USMA talent. Provides coaching, direction, feedback and guidance as needed. Evaluate team progress against goals/objectives. Manage budgets and resources efficiently for USMA supported activities within the USMA plan, is required. Experience in collaboration with US Oncology Franchise Head oncology therapeutic area is required Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) - An advanced doctorate degree (PharmD, PhD, MD, DO or equivalent) in medical/ scientific area required - MD preferred - Experience in oncology therapeutic area required Experience Qualifications - 10 or More Years Pharmaceutical industry experience or commensurate healthcare or research experience required - 4 or More Years Minimum of 5 years of (in-house) medical affairs or related experience, US preferred required - Must have oncology experience, specifically in solid tumors. Previous overall responsibility and accountability for multiple indications of one or more compounds and related USMA plan/budget for related MA activities Demonstrated ability to lead and influence others internally and externally &bull; Experience leading matrix medical teams and representing medical on cross-functional leadership teams (e.g. US Product Team, US Brand Team, Global Medical Team, etc.) Relationships with or proven history developing key external experts &bull; Proven ability to manage multiple priorities at one time required and - Knowledge of ADC or other biologics, or small molecules &bull;Demonstrated experience working with an alliance partner company preferred Travel Ability to travel up to 20% Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Senior Director US Oncology Medical Affairs - TA Lead

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to the effective strategy, design, execution, and interpretation of Oncology clinical trials. Serves as a primary source of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external network, Manages Phase 1 - Phase 3 studies (depending on assignment) with demonstrated decision-making capabilities. Provides medical and scientific expertise to cross-functional DSI colleagues. Responsibilities: Medical Monitoring:<ul><li>For studies in which Medical Monitoring activities are conducted in-house:</li><li>Provides medical input regarding country feasibility. Consulted on decisions related to clinical trial feasibility and contributes to the site feasibility assessment from a physician's perspective</li><li>May provide clinical input into the eCRF (Case Report Form) design, participate in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) review</li><li>Conducts clinical data review per Integrated Data Review Plan</li><li>Accountable for the assessment of protocol deviations</li><li>Discusses medical eligibility questions and answers safety questions (dose modifications, discontinuations, and management of adverse events)</li><li>May participate in Site Initiation Visit (SIV) and conduct medical monitoring visits at any time during the conduct of the study to provide medical input</li><li>Provides medical guidance for coding of AEs, medical history, and medications when needed</li><li>Addresses medical questions directly from sites/ Institutional Review Boards (IRBs), and other site personnel as needed</li><li>Study-specific subject matter expert (ME) for internal audit or Health Authority (HA) questions related to medical monitoring</li><li>For studies in which Medical Monitoring activities are conducted by the Contract Research Organization (CRO) Medical Monitor (MM):</li><li>Provides oversight to the CRO MM for clinical data review activities</li><li>May support addressing eligibility and medical questions from sites/ IRBs</li><li>May provide medical guidance for coding of AEs, medical history, and medications when needed</li></ul>Clinical Development Expertise Strategy:<ul><li>In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of the Clinical Development Plan (CDP). Ensures individual protocols are consistent with CDP and aligned to achieve the Target Product Profile (TPP)</li><li>Development of clinical sections of trial-level regulatory documents (e.g., response to HAs, briefing book, etc.) in conjunction with Medical Writing</li><li>Leads scientific components of IM (Investigators Meeting) and SIV (Site Initiation Visit) Training: compound, Diagnosis (Dx) Overview, in collaboration with Clinical Scientists (CS)</li><li>Interpretation and presentation of clinical study(ies) data to internal and external stakeholders</li><li>Provides medical/scientific training on compound/disease and dose modifications/discontinuations as well as management of adverse events based upon approved Safety Management Team (SMT) materials</li><li>Supports overall program safety reporting (e.g., Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety-related documents, in collaboration with the Safety Physician</li><li>Maintain up-to-date knowledge of all-important advances within a disease area through scientific literature, critical meetings, and relationships with Key External Experts (KEEs). Contributes to clinical/scientific training of relevant DSI stakeholders on the disease area, competitive landscape, and compound/drug. May serve as speaker for program/ franchise medical/scientific training in collaboration with the GCL, if applicable</li><li>Delivers all relevant components needed for maintenance of product licenses (e.g., Core Data Sheet generation/revision; clinical benefit-risk assessments for license renewals, responses to Health Authority)</li><li>Participant and voting member in the labeling development process in the Labeling Working Team (LWT), in collaboration with the CDL</li><li>Contributes from a medical strategy standpoint to developing the Clinical Study Report (CSR). May review tables, listings, and figures (TLF) and CSR safety narratives</li><li>May lead the development and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of the other sections in collaboration with the other authoring functions</li><li>Accountable for Protocol content/study design development</li><li>Contributes from a medical strategy standpoint to the development of clinical sections of study-level documents (e.g., protocol, amendments)</li><li>Reviews safety data to mitigate risk to trial participants for the assigned trial per protocol</li><li>Development of charters for the Steering Committee (SC), Endpoint Committee, and Data Monitoring Committee (DMC). Identify committee members and coordinate/facilitate meetings</li><li>Primary contact for DMC, Endpoint Committee, and SC: Reviews; Presents study updates to the DMC in the open session</li><li>Reports on/prepares presentation material of trial safety information/data to internal and external safety boards (e.g., DMC, SC, Ad boards).</li><li>TPP and EPP (Expected Product Profile) development in collaboration with peer functions and CS</li><li>Oversight of Academic Research Organization (ARO) or Cooperative Group partnership, if applicable</li></ul>Health Authority Interactions Publications:<ul><li>May contribute to addressing questions about medical decisions, clinical data review, protocol deviations, etc., and/or scientific aspects of the study during FDA, MHRA, EMA, and PMDA interactions, such as pre-submissions, end of phase 1/2, and inspections</li><li>May support the GCL, if applicable, in planning and executing the overall publication and clinical communication strategy (overall or at the individual trial level), providing input to key external presentations.</li><li>Contributes to and serves as the medical point of expertise in key Health Authority interactions and Ad board meetings</li></ul>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education:<ul><li>MD required</li><li>Postgraduate training in TA or related specialty required</li></ul>Experience: <ul><li>7 or More Years relevant clinical experience required</li></ul>Travel:<ul><li>Ability to travel up to 20% Domestic and International travel will be required.</li></ul>Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Senior Director, Clincial Development - Oncology R&D

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to the effective strategy, design, execution, and interpretation of Oncology clinical trials. Position Summary / Objective <ul><li>Serves as a primary source of medical accountability and oversight for one or more clinical trials</li><li>Matrix management responsibilities across the internal and external network</li><li>Manages Phase 1 - Phase 3 studies (depending on assignment) with demonstrated decision-making capabilities</li><li>Provides medical and scientific expertise to cross-functional DSI colleagues</li></ul>Responsibilities: Medical Monitoring:<ul><li>For studies in which Medical Monitoring activities are conducted in-house:</li><li>Provides medical input regarding country feasibility. Consulted on decisions related to clinical trial feasibility and contributes to the site feasibility assessment from a physician's perspective</li><li>May provide clinical input into the eCRF (Case Report Form) design, participate in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) review</li><li>Conducts clinical data review per Integrated Data Review Plan</li><li>Accountable for the assessment of protocol deviations</li><li>Discusses medical eligibility questions and answers safety questions (dose modifications, discontinuations, and management of adverse events)</li><li>May participate in Site Initiation Visit (SIV) and conduct medical monitoring visits at any time during the conduct of the study to provide medical input</li><li>Provides medical guidance for coding of AEs, medical history, and medications when needed</li><li>Addresses medical questions directly from sites/ Institutional Review Boards (IRBs), and other site personnel as needed</li><li>Study-specific subject matter expert (ME) for internal audit or Health Authority (HA) questions related to medical monitoring</li><li>For studies in which Medical Monitoring activities are conducted by the Contract Research Organization (CRO) Medical Monitor (MM):</li><li>Provides oversight to the CRO MM for clinical data review activities</li><li>May support addressing eligibility and medical questions from sites/ IRBs</li><li>May provide medical guidance for coding of AEs, medical history, and medications when needed</li></ul>Clinical Development Expertise Strategy:<ul><li>In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of the Clinical Development Plan (CDP). Ensures individual protocols are consistent with CDP and aligned to achieve the Target Product Profile (TPP)</li><li>Development of clinical sections of trial-level regulatory documents (e.g., response to HAs, briefing book, etc.) in conjunction with Medical Writing</li><li>Leads scientific components of IM (Investigators Meeting) and SIV (Site Initiation Visit) Training: compound, Diagnosis (Dx) Overview, in collaboration with Clinical Scientists (CS)</li><li>Interpretation and presentation of clinical study(ies) data to internal and external stakeholders</li><li>Provides medical/scientific training on compound/disease and dose modifications/discontinuations as well as management of adverse events based upon approved Safety Management Team (SMT) materials</li><li>Supports overall program safety reporting (e.g., Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety-related documents, in collaboration with the Safety Physician</li><li>Maintain up-to-date knowledge of all-important advances within a disease area through scientific literature, critical meetings, and relationships with Key External Experts (KEEs). Contributes to clinical/scientific training of relevant DSI stakeholders on the disease area, competitive landscape, and compound/drug. May serve as speaker for program/ franchise medical/scientific training in collaboration with the GCL, if applicable</li><li>Delivers all relevant components needed for maintenance of product licenses (e.g., Core Data Sheet generation/revision; clinical benefit-risk assessments for license renewals, responses to Health Authority)</li><li>Participant and voting member in the labeling development process in the Labeling Working Team (LWT), in collaboration with the CDL</li><li>Contributes from a medical strategy standpoint to developing the Clinical Study Report (CSR). May review tables, listings, and figures (TLF) and CSR safety narratives</li><li>May lead the development and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of the other sections in collaboration with the other authoring functions</li><li>Accountable for Protocol content/study design development</li><li>Contributes from a medical strategy standpoint to the development of clinical sections of study-level documents (e.g., protocol, amendments)</li><li>Reviews safety data to mitigate risk to trial participants for the assigned trial per protocol</li><li>Development of charters for the Steering Committee (SC), Endpoint Committee, and Data Monitoring Committee (DMC). Identify committee members and coordinate/facilitate meetings</li><li>Primary contact for DMC, Endpoint Committee, and SC: Reviews; Presents study updates to the DMC in the open session</li><li>Reports on/prepares presentation material of trial safety information/data to internal and external safety boards (e.g., DMC, SC, Ad boards).</li><li>TPP and EPP (Expected Product Profile) development in collaboration with peer functions and CS</li><li>Oversight of Academic Research Organization (ARO) or Cooperative Group partnership, if applicable</li></ul>Health Authority Interactions Publications:<ul><li>May contribute to addressing questions about medical decisions, clinical data review, protocol deviations, etc., and/or scientific aspects of the study during FDA, MHRA, EMA, and PMDA interactions, such as pre-submissions, end of phase 1/2, and inspections</li><li>May support the GCL, if applicable, in planning and executing the overall publication and clinical communication strategy (overall or at the individual trial level), providing input to key external presentations.</li><li>Contributes to and serves as the medical point of expertise in key Health Authority interactions and Ad board meetings</li></ul>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education:<ul><li>MD required</li><li>Postgraduate training in TA or related specialty required Experience Qualifications</li><li>7 or More Years relevant clinical experience required</li></ul>Travel:<ul><li>Ability to travel up to 20% Domestic and International travel will be required.</li></ul>Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Senior Director, Clinical Development - Hematology

Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary A cross-Oncology Development Medical Doctor position reporting to the Head Clinical Development Functional Excellence. This position complements CSPV and GMA efforts with a comprehensive and all-encompassing approach to coordinate activities, under the leadership of the Head of Functional Excellence, across key functions to improve the benefit-risk in patients treated within the oncology compounds throughout the course of clinical development through the commercial setting. In this role, the incumbent will contribute to creation and improvement of Clinical Development processes. Job Description: <ul><li> Execute an overarching safety program tailored for AEs from end-to-end: understanding predisposing non-clinical and clinical factors, diagnosis, effective management during clinical trials and beyond in post approval setting. </li><li> Responsible for the execution of key safety initiatives aimed at preventing, mitigating, and addressing critical safety issues including but not limited to protocol amendments, Dear HCP letters and key medical education initiatives.</li><li> Develops prospective contingency plans for management of assigned safety risks across projects; Clearly defines priorities and high-level execution plans across and effective alignment within (e.g. with translational research, clinical operations, clinical development, medical affairs CSPV and other internal groups) and outside of Daiichi Sankyo (e.g. clinical trial sites, CROs, collaboration partners); Supports effective direct communication with clinical sites in collaboration with clinical development staff. </li><li> Consults with KEE's for advice on complex patient safety issues. Communications lead with HCP's (PI's, sub- PI's, nurses) at the site level to ensure that patient safety with respect to the safety risk assigned remains top of mind in the context of patient management in the clinical trial setting and in the real-world setting. </li><li> Contributes to creation and improvement of Clinical Development processes.</li></ul> Education: <ul><li> MD required; prefer Board certification in Oncology.</li></ul> Experience: <ul><li> At least 7 years of experience in pharmaceutical industry. </li><li> At least 2 years in Patient Safety. </li><li> At least 2 years of experience in Clinical Development. </li><li> At least 2 years of Oncology experience. </li></ul> Competencies: <ul><li> An impeccable oncology clinical and medical expert with proven credibility and experienced in patient safety and clinical development.</li><li> Experience working in a matrix environment and on cross-functional teams. </li></ul> Travel requirements: Local and global travel might be required up to 20% Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Senior Director, Oncology R&D Functional Excellence

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. JOB SUMMARY The Senior Director, Head Medical affairs Quality Assurance in Global RD/PV QA is accountable to drive the implementation of a quality strategy and quality plan closely aligned with the Global Oncology Medical Affairs (GOMA), Oncology Business Unit (OBU) and Specialty Business Unit (SBU) Medical Affairs business strategy . This individual is also accountable to promote a quality culture within across the product portfolio by providing governance support, quality oversight of strategic initiatives in close collaboration with cross functional leadership team (ie, OBU, SBU) and study teams to uphold the ethical conduct of interventional, non-interventional, investigator-initiated trials and managed access programs to the highest quality standards. This position reports to the Head, Global Development and Medical Affairs QA RDPVQA, and oversees multiple levels of direct reports (Directors, Associate Directors, Managers, contractors as applicable) across the Global Quality teams located in EU, Americas (including Brazil) and work in close collaboration with Japan. This individual is a member of the Development and Medical Affairs QA leadership team and maybe extended member of the global RD/PV QA leadership team. The position will represent QA at Global Oncology Medical Affairs LT, Specialty MA LT, Development (as applicable), GMP QA, and engagement with external partners as deemed necessary. This position is accountable to drive a proactive approach to quality and instilling a shared passion for building a stronger Quality organization with One Quality voice as the best trusted quality partner with internal and external stakeholders. The incumbent must aim to instill a consistent quality mindset and culture through partnering with stakeholders to streamline the product lifecycle process and develop risk mitigation strategies. Provide comprehensive quality oversight and strategic quality guidance/advice to the MA functions located in the Americas and EU and collaborate with Research QA and Development QA to provide QA advise wherever necessary for shared services between R&D and Medical affairs, particularly in case when issues impact Medical Affairs programs. Ensure requirements are in place for quality oversight of marketed products in collaboration with Research QA, PV QA, CSPV and other internal QA stakeholders such as GMP QA, specifically for specialty pharmacy, REMS, co-partners and affiliates. Liaise with Audit and Compliance team to ensure that Global Medical Affairs audits are properly planned, communicated and that audit targets for MA audits are in place. Review risk assessment documents stemming from audit outcome to increase compliance within MA function. Improve/strengthen QA engagement with Global Oncology Medical Affairs, Specialty Medical affairs, through lessons learned, process improvement and ongoing collaborations. Provide end to end process consultation impacting products from a quality perspective. Provide regular updates to management on Mid Term strategy (MTS) for MA QA area and propose improved objectives as necessary. Deliver risk mitigation strategies and process improvements to stakeholders via the QMS framework (i.e., Quality Management Review, Quality Review Board) across the global medical affairs organization (Oncology and SM) and relevant external stakeholders. The role will manage and or support medical affairs Quality resources (US, Brazil, Japan/ APAC and EU):in an efficient and effective manner including, but not limited to oversight of defined work products, coaching and mentoring of global team, performance management and driving/contributing to organizational effectiveness/efficiencies. RESPONSIBILITIES Customer Focus <ul><li> Provide Medical Affairs quality oversight of the Oncology and Specialty Medicine portfolios, in alignment with the business strategy </li><li> Lead the DSG inspection management activities by ensuring continued submission, compliance and inspection preparedness for the respective MA inspections in alignment with regulatory and company strategy. </li><li> Act as management representative for all key health authority inspections (US FDA, EU EMA, MHRA etc.,). Develop and maintain an effective working relationship with US FDA and other international bodies. </li><li> Ensure adequate CAPAs are defined, implemented, and closed through providing guidance and facilitation of quality event resolution </li><li> Proactively ensure that all functions consistently operate in a state of compliance. </li><li> Facilitate the implementation of the quality strategy in close alignment with the MA (Oncology and Specialty) business strategy. Monitor and track implementation and break-down of the Quality Manual into an annual Quality Plan together with the supported MA teams, including the quality risk assessments and inspection readiness components for the designated programs. </li><li> Ensure proactive representation of Quality professionals at strategic non-project team and at MA strategic discussions. </li><li> Lead the Quality Reviews of respective product profile to ensure appropriate management review of all quality and compliance related topics including the review of Key Quality Indicators (KQIs). Collaborate with Global QA teams in US, Japan, APAC , Europe and Brazil to ensure relevant quality reports and or assigned by Head, Global Development and Medical Affairs QA delivered in a timely manner. Ensure that risks are duly identified, mitigated in collaboration with the business functions. Identify appropriate continuous improvement initiatives for quality and compliance related areas. </li><li> May Deputize for the Head, Global Development and Medical Affairs QA at Leadership teams, as appropriate and as needed. </li></ul> Oversight: Provide strategic direction pertinent to MA activities for internal QA team (global/ local), but also to: <ul><li> Global Project Teams </li><li> GOMA and Specialty MA Management t eams </li><li> Data Management/ Biostats </li><li> Clinical Safety and Pharmacovigilance </li><li> R&D </li><li> Vendors/ CROs/ third parties </li><li> HEOR/ RWE </li><li> Epidemiology </li><li> Legal and compliance </li><li> Marketing/ commercial </li><li> GMP QA/ Supply chain / Regulatory Affairs </li></ul> Leadership/ team management: <ul><li> Create a high performing team environment and a cohesive culture driven by values of integrity, respect, and a speak up culture </li><li> Lead and hold others accountable to performance, talent, and development objectives </li><li> Create an environment that fosters diversity of thoughts, inclusivity and one that adheres to the principals set forth in the organization (JOIN, GROW, THRIVE) </li><li> Create an environment that thrives on innovation, proactive quality and is disciplined to efficiently execute against pre-defined deliverables </li><li> Drive employee engagement, mentoring, coaching and performance management </li><li> Exhibit servant leadership while driving results. </li><li> Collaborate with internal and external stakeholders </li><li> Interact with senior MA/functional leadership teams to ensure Quality is consistently and proactively represented at program level and support proactive quality risk management process. </li><li> Interact with the audit and compliance function for the development of the UAP pertinent to MA area. </li><li> Partners with the respective cross functional groups, CROs, Affiliates in order to ensure high data quality and proactive detection and resolution of issues. </li></ul> External Engagement: <ul><li> Continuously review compliance metrics trends from regulators/ industry experts and align develop the MA road map to meet changing regulatory and business needs. Assure a closed loop of MA risks identified through audits, inspections, internal meetings, remediation and risk management in close collaboration with the organization's quality management system, to assure robust knowledge transfer and continuous process improvement. </li><li> Drive effective relationship with alliance partners, legal and compliance, collaborators, Marketing, R&D, vendors, and other key company partners to ensure a culture of compliance at all levels </li><li> Influence change to drive continuous process improvement with stakeholders </li></ul> Strategy: <ul><li> Contribute to shape the strategic direction of the global Development and Medical QA function based on the organization's mid-term plan and beyond </li><li> Ensure adequate MA QA (Americas/Europe Brazil) resource are in place and contribute to create a long term strategy for global MA QA across regions and geographic areas. </li><li> Contribute to create and maintain the strategic road map, metrics, dashboard, and project management methodologies to lead an efficient and effective organization </li><li> Support the global quality annual objectives, strategic initiatives to deliver against the business plan. </li><li> In close collaboration with GMP QA, CSPV, PV QA, Research QA create a framework for cross collaboration related to marketed / commercial products whereby MA is in scope for label extension, safety only studies (PH IV studies) and/ or EAP (Expanded access, lead and drive the strategic direction to ensure adequate QMS is in place for continuous improvement. </li></ul>BASIC QUALIFICATIONS Education<ul><li>Must have a BS Degree in a in scientific, health care, or related discipline; and/or background in Medical Health Profession (RN, Medical technologist, etc.) </li><li>A Master's Degree strongly preferred.</li></ul>Required Skills<ul><li>10 or more years of professional experience at senior management level leading quality organization and demonstrated track record of successful results, or equivalent experience from any of these industries: Pharmaceuticals, biologics, Medical Device, Vaccines, Diagnostics, Generics/ Consumer products </li><li>Demonstrated expertise in managing many aspects of quality in an international, global context in a regulated health care environment </li><li>Proven ability to work directly with global Health Authorities (FDA, EMA, MHRA) and other government and local agencies </li><li>Expert knowledge required for the end-to-end Drug development process in R&D space </li><li> Strong therapeutic experience specifically Oncology (biologics) is highly preferred. </li></ul>Travel Requirement<ul><li>Must have the ability to travel both domestic and globally up to 20% of the time.</li></ul>Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Sr. Director, Medical Affairs QA

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