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 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: - 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. - 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. - 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. - 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 - 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. 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 - 8+ Years of relevant experience in the pharmaceutical industry with a masters degree required - 5+ Years of relevant experience in the pharmaceutical industry with a PhD 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.

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Assoc Director Biostatistics

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 desired. preferred - 7 or More Years Bachelor's degree with minimum 7 years (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.

Associate Director BDM 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. Summary The purpose of this job is to lead certain pipeline support activities and assist in the identification, coordination assessment, and securing of pipeline- and portfolio-enhancing, business opportunities (through licensing, acquisition, co-promotion, and other structures). This role will, at times, interface with DS's Oncology Business Unit and the Specialty Medicine Business Units and is responsible for executing business development opportunities across a range of categories designed to advance the existing pipeline (including companion diagnostic deals, combination studies, and ARO collaborations). This role will also support more complex projects, including those to acquire new product opportunities or technologies to augment our pipeline. This person is responsible for coordinating cross-functionally (e.g with commercial, R&D, legal, IP, finance, supply chain, and other relevant functional area colleagues), at varying levels, and across geographies. Externally, the job requires initial meetings with potential partners; coordination of capability presentations; coordination of diligence meetings; leading negotiation sessions in concert with senior GBD Transactions team members; and alliance management participation following successful completion of business arrangements. This role may also require participation in supervising, training and developing entry-level business development professionals within the Global BD function (e.g. Fellow). Responsibilities - Execute assigned transactions through proposal/review/negotiation of EOI/NBTS and Definitive Agreements, either acting as Lead for simple opportunities or supporting more complex transactions. Work in concert with key Functional Area Leads (esp. OBU, RD Finance, RD (GPTL), BD Legal and others) and Senior Management Global BD/DS Corporate Tokyo to secure alignment on key terms and conditions prior to and during active negotiations. Communicate activities frequently across the organization through related internal approval committees including (but not limited to) EMC. - Communications should include sharing of key contract related terms and conditions to key stakeholders as well as the related strategic, financial, scientific and commercial rationale for each opportunity reflecting internal analyses as well as diligence activities. Respond to QA from Finance, Tokyo BD, Oncology Business Unit, GPTs, CBM, Senior Management, and other key stakeholders as indicated. - Meet with other pharmaceutical company licensing groups, participate in industry meetings. - Together with colleagues from Search and Evaluation, coordinate with commercial, RD, finance, supply chain, IP, legal, etc., on both preliminary and full assessments of potential opportunities, and summarize conclusions and recommendations for discussion with and presentation to senior management. Schedule and lead diligence meetings with potential partners. - Support other special projects, including initiatives within and external to GBD, to improve processes and workflows 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 BA/BS/MS/PharmD plus MBA or JD with relevant experience required - Master's Degree preferred - JD preferred - PharmD preferred Experience Qualifications - 4 or More Years 5 years within the pharmaceutical industry required - 4 or More Years Previous Big Pharma experience required - 4 or More Years Branded oncology transactions experience required - Matrix experience preferred Travel Ability to travel up to 30% Overnight travel dictated by conference schedules, global licensing meetings and deal related activities 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, GBD Transactions

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 position is responsible for managing Interactive Response Technology (IRT)-related activities across multiple clinical trials and / or at the vendor level according to Good Clinical and Manufacturing Practices (GCP. GMP), and Daiichi Sankyo standard practices. A successful candidate will be responsible for providing subject matter expertise in IRT while driving the development and delivery of IRT systems across global matrixed teams. Responsibilities Manage and coordinate IRT-related activities and timelines during study initiation, start-up, conduct, closeout, and archival. These activities will include:<ul><li>Providing input into the Request for Proposal (RFP) process and protocol development process for assigned clinical trials;</li><li>Managing and contributing to the IRT system development lifecycle, including requirements gathering, user acceptance testing, issue management, change management and decommissioning activities, to minimize unanticipated impacts across programs and stakeholders;</li><li>Supporting transparency in operational planning through tracking IRT-related milestones and dashboard inputs;</li><li>Ensuring inspection readiness of IRT-related items for assigned clinical trials.</li><li>Develop and manage the Request for Proposal (RFP) process for new IRT systems.</li><li>Lead Operational Management Team (OMT) responsibilities for assigned IRT vendors.</li><li>Support compliance audits, IRT vendor audits and regulatory inspections.</li><li>Lead and/or contribute to cross-functional and global improvement projects that include IRT-related data and/or IRT vendors.</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 in life sciences or medically related field required</li><li>Master's Degree in life sciences or medically related field preferred</li></ul>Experience Qualifications<ul><li>7 or More Years related experience in life sciences or medically related field including 6 years of supporting pharmaceutical/biopharmaceutical clinical research experience (obtained by working on clinical trials at a pharmaceutical, biopharmaceutical, CRO or relevant vendor) required</li><li>7 or More Years direct experience leading IRT-related projects with cross-functional stakeholders required</li><li>4 or More Years direct managerial and/or leadership experience preferred</li><li>Ability to travel up to 10% Single day / overnight / multi-day travel will be required to go to outsourced vendors or company offices.</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, IRT Center of 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. <ul><li>Global Oncology therapeutic area experience required.</li><li>The SDL is an experienced matrix leader.</li></ul>Job Summary: The Study Delivery Lead (SDL) Associate Director - leads the cross functional core and extended clinical study team in end-to end delivery of the clinical trial with consistency, quality and per planned timelines. The SDL has the accountability for 1 or several complex studies in various settings including Phase I-III, within a delivery model comprising of outsourced studies or outsourced studies with elements of insourcing. This includes global operational execution and delivery of clinical studies across multiple geographic regions, in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Health Authority regulations, International Conference on Harmonization (ICH) guidelines and local regulations, as required. The SDL is accountable for operational planning and execution at the study level with responsibility for clinical study plans and execution (from planning start-up, conduct, reporting and close out) including timeline, and budget. The SDL will partner with the Strategic Vendor Oversight (SVO) team and collaborate with the core and extended team to ensure robust CRO oversight including 3rd party vendors to achieve study milestones and deliverables according to agreed quality standards and timelines and that quality of data is suitable for regulatory submission. The SDL collaborates with cross-functional stakeholders and the Metrics, Analytics, Reporting and Solutions (MARS) team to drive and monitor progress. The SDL fosters an environment where the core study team maximizes their expertise and contribution to trial delivery, including but not limited to issue resolution, risk mitigation and escalation to Global Project Team (GPT), SCORE and other governance level as needed The SDL will have regular interactions with key internal and external stakeholders to discuss project status, escalate issues, and troubleshoot inquiries. For this role, strong written and verbal communication skills in English, operational leadership, and decision-making, ability to delegate, strategic thinking, conflict resolution, clinical project management experience and attention to detail are required. The SDL is an experienced matrix leader and serves as a mentor to more junior colleagues on clinical trial execution. Outside interfaces may include other Daiichi-Sankyo business groups and subsidiaries in the US and abroad, governmental, academic, community and industry organizations. The SDL is the reference and role model within the study delivery lead team that drives the culture for a healthy team. The role is primarily responsible for Operational Study Strategy and Study Execution while exhibiting leadership qualities. Responsibilities:<ul><li>Lead the core study team while project managing and collaborating with internal stakeholders to ensure cross functional integration and delivery of study milestones (e.g. protocol, eCRF/EDC, IXRS, Clinical Study Oversight Plan etc.)</li><li>Ensure operational study-level timeline, budget, deliverables and quality management-Facilitate escalation and resolution of issues with CRO/ vendors/ site/ country performance raised by the study team, including serious quality incidents and serious breaches of GCP. The SDL is accountable for escalation to the OPL/Asset Lead (or Senior Line Leaders in the absence of Asset Lead).</li><li>Where appropriate, may delegate certain responsibilities to Study Manager(s) assigned to the study</li><li>Protocol Development, and Team Assembly-Contribute to and interface with different levels of study governance, as required-Oversee the development of the clinical study plan including critical path activities and interdependencies for assigned clinical stud(ies)</li><li>Provide operational input into concepts, CDP, study protocol profiles, final protocols and amendments</li><li>Participate in protocol and amendment review. Contribute to the development of and oversee delivery timelines of ICF, IB and safety communications, DSUR, IND.-Partner with other functional leaders to address core study team gaps and ensures accurate and complete study team list is maintained.</li><li>In partnership with the lead physician, Clinical Scientist and all study team members, accountable for the co-ordination and conduct of feasibility process for protocol development in alignment with the CDP/IEP.</li><li>Application of feasibility analysis to manage study implementation in the clinical and regulatory environment across participating regions, provide quality data and ensure timely study delivery</li><li>Lead the CRO and vendor selection process and scope of work in collaboration with the study team and Procurement Management.</li><li>Lead trial feasibility and site identification and qualification activities in collaboration with the CRO, feasibility team and the study team.</li><li>Assist Data Management with development of the clinical database (edit checks, CCG development, and UAT)</li><li>Study Conduct and Oversight-Ensure operational adherence to the clinical study oversight plan</li><li>Reinforce CRO/Vendor accountability for trial execution and quality data delivery. Foster a culture of empowerment and accountability for CRO to resolve study issues internally, raising such for DS action per exception/defined criteria for escalation-Monitor clinical trial performance and quality metrics and share with study team and GPT on regular basis and ensure actions are taken (at the study team level and CRO and vendors levels) and/or issues / risks are escalated to project team level and relevant governance bodies-Lead escalation and resolution of issues with CRO/ vendors/ site/ country performance including serious quality incidents and serious breaches of GCP. Triage, resolve or escalate study issues /risk mitigations as per JOC/ESC and other established forums. The SDL is accountable for escalation to the Asset Lead (or Senior Line Leaders in the absence of Asset Lead).</li><li>Monitor study budget against trial progress and Inform Finance of deviations-Review and approve Vendor invoices, including investigator grants and pass through costs.</li></ul>Quality and Inspection Readiness:<ul><li>Support inspection readiness and quality initiatives pertaining to assigned study(ies).</li><li>Serve as primary SME engaged in dialogue with inspector(s) to address study inquiries throughout course of HA inspection-Ensure trial master file is complete and accurate for assigned stud(ies).</li><li>Ensure that a study level operational risk management plan is in-place and applies a smart-risk taking philosophy</li><li>Responsible for the delivery, oversight, performance and management of 3rd party vendors to ensure compliance with Daiichi Sankyo's quality measures and adherence to scope of work within timelines and budget at a task level.</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 field and a minimum of 7 years relevant experience required</li></ul>Experience:<ul><li>Experience in global clinical operations methods and processes in industry setting is required required</li><li>Experience considered relevant includes clinical or basic research in a pharmaceutical company, a medical device/Diagnostic company, Academic Research Organization (ARO), hospital/medical setting or Contract Research Organization (CRO). Clinical Project Management experience required. required</li><li>CRA experience is preferred preferred</li><li>Familiarity with a Japan-based organization is beneficial 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, Study Delivery Lead - Global Clinical Operations - 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. <ul><li>2+ years in FIH/Phase 1 Oncology Clinical Trials Preferred</li></ul><ul><li>The SDL is an experienced matrix leader.</li></ul>Job Summary: The Study Delivery Lead (SDL) Associate Director - leads the cross functional core and extended clinical study team in end-to end delivery of the clinical trial with consistency, quality and per planned timelines. The SDL has the accountability for 1 or several complex studies in various settings including Phase I-III, within a delivery model comprising of outsourced studies or outsourced studies with elements of insourcing. This includes global operational execution and delivery of clinical studies across multiple geographic regions, in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Health Authority regulations, International Conference on Harmonization (ICH) guidelines and local regulations, as required. The SDL is accountable for operational planning and execution at the study level with responsibility for clinical study plans and execution (from planning start-up, conduct, reporting and close out) including timeline, and budget. The SDL will partner with the Strategic Vendor Oversight (SVO) team and collaborate with the core and extended team to ensure robust CRO oversight including 3rd party vendors to achieve study milestones and deliverables according to agreed quality standards and timelines and that quality of data is suitable for regulatory submission. The SDL collaborates with cross-functional stakeholders and the Metrics, Analytics, Reporting and Solutions (MARS) team to drive and monitor progress. The SDL fosters an environment where the core study team maximizes their expertise and contribution to trial delivery, including but not limited to issue resolution, risk mitigation and escalation to Global Project Team (GPT), SCORE and other governance level as needed The SDL will have regular interactions with key internal and external stakeholders to discuss project status, escalate issues, and troubleshoot inquiries. For this role, strong written and verbal communication skills in English, operational leadership, and decision-making, ability to delegate, strategic thinking, conflict resolution, clinical project management experience and attention to detail are required. The SDL is an experienced matrix leader and serves as a mentor to more junior colleagues on clinical trial execution. Outside interfaces may include other Daiichi-Sankyo business groups and subsidiaries in the US and abroad, governmental, academic, community and industry organizations. The SDL is the reference and role model within the study delivery lead team that drives the culture for a healthy team. The role is primarily responsible for Operational Study Strategy and Study Execution while exhibiting leadership qualities. Responsibilities:<ul><li>Lead the core study team while project managing and collaborating with internal stakeholders to ensure cross functional integration and delivery of study milestones (e.g. protocol, eCRF/EDC, IXRS, Clinical Study Oversight Plan etc.)</li><li>Ensure operational study-level timeline, budget, deliverables and quality management-Facilitate escalation and resolution of issues with CRO/ vendors/ site/ country performance raised by the study team, including serious quality incidents and serious breaches of GCP. The SDL is accountable for escalation to the OPL/Asset Lead (or Senior Line Leaders in the absence of Asset Lead).</li><li>Where appropriate, may delegate certain responsibilities to Study Manager(s) assigned to the study</li><li>Protocol Development, and Team Assembly-Contribute to and interface with different levels of study governance, as required-Oversee the development of the clinical study plan including critical path activities and interdependencies for assigned clinical stud(ies)</li><li>Provide operational input into concepts, CDP, study protocol profiles, final protocols and amendments</li><li>Participate in protocol and amendment review. Contribute to the development of and oversee delivery timelines of ICF, IB and safety communications, DSUR, IND.-Partner with other functional leaders to address core study team gaps and ensures accurate and complete study team list is maintained.</li><li>In partnership with the lead physician, Clinical Scientist and all study team members, accountable for the co-ordination and conduct of feasibility process for protocol development in alignment with the CDP/IEP.</li><li>Application of feasibility analysis to manage study implementation in the clinical and regulatory environment across participating regions, provide quality data and ensure timely study delivery</li><li>Lead the CRO and vendor selection process and scope of work in collaboration with the study team and Procurement Management.</li><li>Lead trial feasibility and site identification and qualification activities in collaboration with the CRO, feasibility team and the study team.</li><li>Assist Data Management with development of the clinical database (edit checks, CCG development, and UAT)</li><li>Study Conduct and Oversight-Ensure operational adherence to the clinical study oversight plan</li><li>Reinforce CRO/Vendor accountability for trial execution and quality data delivery. Foster a culture of empowerment and accountability for CRO to resolve study issues internally, raising such for DS action per exception/defined criteria for escalation-Monitor clinical trial performance and quality metrics and share with study team and GPT on regular basis and ensure actions are taken (at the study team level and CRO and vendors levels) and/or issues / risks are escalated to project team level and relevant governance bodies-Lead escalation and resolution of issues with CRO/ vendors/ site/ country performance including serious quality incidents and serious breaches of GCP. Triage, resolve or escalate study issues /risk mitigations as per JOC/ESC and other established forums. The SDL is accountable for escalation to the Asset Lead (or Senior Line Leaders in the absence of Asset Lead).</li><li>Monitor study budget against trial progress and Inform Finance of deviations-Review and approve Vendor invoices, including investigator grants and pass through costs.</li></ul>Quality and Inspection Readiness:<ul><li>Support inspection readiness and quality initiatives pertaining to assigned study(ies).</li><li>Serve as primary SME engaged in dialogue with inspector(s) to address study inquiries throughout course of HA inspection-Ensure trial master file is complete and accurate for assigned stud(ies).</li><li>Ensure that a study level operational risk management plan is in-place and applies a smart-risk taking philosophy</li><li>Responsible for the delivery, oversight, performance and management of 3rd party vendors to ensure compliance with Daiichi Sankyo's quality measures and adherence to scope of work within timelines and budget at a task level.</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 field and a minimum of 7 years relevant experience required</li></ul>Experience:<ul><li>Experience in global clinical operations methods and processes in industry setting is required</li><li>Experience considered relevant includes clinical or basic research in a pharmaceutical company, a medical device/Diagnostic company, Academic Research Organization (ARO), hospital/medical setting or Contract Research Organization (CRO). Clinical Project Management experience required. required</li><li>CRA experience is preferred</li><li>Familiarity with a Japan-based organization is beneficial preferred</li><li>Strong Global Oncology therapeutic area experience required.</li><li>The SDL is an experienced matrix leader.</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, Study Delivery Lead - Global Clinical Operations - Phase I 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. Job Summary: <ul><li> The intern will be given a topic related to statistical programming, working on or assisting the development of programming tools (such as macros, utilities, or apps). </li><li> The intern will be assigned to a programming project using R/R Shiny to create tools for data visualization and summary tables. The primary goal is for the intern to receive training in statistical programming within a pharmaceutical company and to support basic programming activities under supervision. </li><li> The intern will in certain department activities and initiatives development. </li></ul> Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: <ul><li> Enrolled in a BS or MS program in mathematics or statistics at an accredited college/university, with demonstrated knowledge of scientific programming. </li><li> Available for a full-time, 12-week commitment from June to August. </li><li> Detail-oriented, highly motivated, and able to manage multiple tasks while working both independently and collaboratively as a team member. </li><li> Proficient in at least one of the following programming languages: R/R Shiny, Python, or SAS. </li><li> Strong communication skills. </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.

Biostatistics and Data Mgmt Programming - R Intern

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. Job Summary: Data Engineer will partner with business stakeholders and decision makers to develop solutions to support their analytical needs and business insights. This role will be responsible for designing, developing, and maintaining our company's data architecture, data pipelines, and infrastructure to ensure the effective management, analysis, and utilization of data. This role will collaborate with IT, sourcing partners, data stewards, and business to ensure data integrity, and data security in accordance with business requirements and provide technical and data subject matter expertise where required. Responsibilities - Develop and maintain our company's data infrastructure architecture, including data warehouses and data lakes, to support efficient and effective data management and analysis. Build and maintain robust, scalable, and high-performance data pipelines to extract, transform, and load data from various sources into our data platforms. - Develop, manage, and be accountable for the onboarding of new data source, data blending and integration of multiple data sources, building new reports and dashboards, enhancements of existing processes supporting both Commercial and RD functions. Responsible for managing quality of the deliverables - Serve as point of contact for implementation of complex data projects and development of data management technologies. Provide technical expertise and subject matter expertise. Provide risk analysis, business and technical assessment of requests in relation to data platforms. - Continuously evaluate new data technologies, tools, and platforms to improve data processing, storage, and analysis capabilities. Optimize and tune data infrastructure and systems for performance, reliability, and scalability. - Collaborate with cross-functional teams, including data analysts, data scientists, data stewards and software engineers to ensure data quality, integrity, accuracy, consistency and security across systems and applications. 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 Bachelor's degree in fields such as Computer Science or Information Technology required Experience Qualifications - 4 or More Years 4 or More Years of hands-on experience in applications development, Business Intelligence, and advanced analytics with emphasis on Microsoft Azure suite required - 4 or More Years 4 or more years of hands-on experience with enterprise data warehouse solutions including integration of complex data sources for the deployment of decision support systems required - 1 or More Years Experience with commercial pharmaceutical / business information, Supply Chain, Finance and HR preferred - 1 or More Years Experience with Clinical Trials Data, Genomics and Bio Marker Data, Real World Data, Discovery Data etc. preferred - 1 or More Years Familiarity with and understanding of key industry best practices in regulated GXP" environment preferred - Ability to travel up to 5% 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.

Data Engineer (NJ Based Onsite)

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. 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

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: Provide strategic leadership for BDM activities on compound or cross-compound level safety signal detection. Represent BDM in cross-functional collaborations with safety team. Liaison with biostatistics function to drive signal detection analysis and programming deliverables. Lead the programming early safety integration and signal detection analysis. Lead central statistical monitoring programming supports for RBQM. Responsibilities: - Leading BDM activities on compound or cross-compound level safety signal detection: Represent BDM in cross-functional collaborations with safety team. Work with safety team to identify signal detection needs and develop specifications for resolution. Work with programming technology team to develop macro or tools from the specifications. Liaison with biostatistics function to drive signal detection analysis and programming deliverables. Ensure signal detection BDM deliverables on time and with high quality. - Lead central statistical programming supports for RBQM: Liaison with RBQM related functions to gather technical specifications to develop central statistical monitoring (CSM) Rshiny apps or tools. Work with programming technology team to develop Rshiny apps or tools from the specifications. Lead the CSM programming implementation for study level deliverables. - Leading the programming early safety integration and signal detection analysis: Establish the programming safety team to enable programming for early safety integration and support safety signaling detection analysis. Build integrated safety datasets, and deliver outputs run against safety datasets. - BDM safety Team Management: Typically has administrative responsibility for recruiting, retaining, developing, and managing employees. Guide career growth and provide development opportunity for individuals. People manager of BDM safety team to set up goals/objectives and evaluate individual performances. 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 mathematics, statistics, or computer science preferred - Master's Degree in mathematics, statistics or computer science preferred Experience Qualifications: - 10 or More Years experience in pharmaceutical industry preferred - Thorough understanding and proficiency of CDISC standards. Advanced knowledge of CDISC requirements for DTM and ADaM. preferred - Thorough knowledge and experiences in integrated analysis on safety for submission and/or other purposes. preferred - Experience in programming innovations beyond traditional SAS programming preferred - Worked and played major role in electronic NDA and/or BLA submission via eCTD preferred - Working knowledge in R and/or Python preferred - Strong project management experience and ability to manage and execute multiple projects and deadlines. 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.

Director of Programming, Safety 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. This position will be supporting early clinical safety for our Rare Disease/Specialty Medicine portfolio. Summary<ul><li>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.</li><li>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.</li><li>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).</li></ul>Responsibilities<ul><li>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.</li><li>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.</li><li>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.</li><li>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.</li><li>Define and implement strategies and action plans for identifying and managing risks throughout the product life cycle.</li><li>Effectively coordinate and manage available resources in developing and delivering high-quality safety evaluation related documents/deliverables on time.</li><li>Coordinate and participate actively in safety-related regulatory interactions (e.g., regulatory meetings, post-approval commitments).</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>MD Board certification or eligibility required</li></ul>Experience Qualifications<ul><li>4 or More Years of experience in the pharmaceutical industry, regulatory agency or academia, with exposure to drug development, clinical pharmacology, and/or epidemiology. Required </li><li>Expertise in Rare Disease or Specialty Medicine strongly 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.

Director, Clinical Safety, MD (Rare Disease/Specialty Medicine)

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: Senior clinical operational leader accountable for operational planning and execution of FIH, clin pharm patient studies, and Phases 1-3 clinical trials at the study and program level. Responsible for clinical program planning and execution (from study design, operational planning, start-up, conduct, reporting, and close out) including timeline, quality, and budget management. Drives and leads the successful execution of all operational components of a large-scale global clinical program using strong clinical project and program management, leadership, decision-making ability, people management, and organizational skills and expert level written and verbal communication skills. The role is primarily responsible for Operational Program Strategy and Execution and will have the responsibility of managing multiple direct reports. Responsibilities: Operational Strategy:<ul><li>Align with the Head of Clinical Development Operations or Senior Director, Clinical Operations on plans for successful implementation of studies. Responsible for management of compounds at the program and franchise levels. May represents Clinical Operations on the Strategy and Portfolio or Clinical Sub Teams in their therapeutic area.</li><li>Ensure operational aspects are incorporated into CDP planning and individual protocols to facilitate successful implementation of programs.</li></ul>Clinical Operations:<ul><li>Ensure high quality delivery of all studies for which they are responsible. This includes individual studies as well as programs or franchises.</li><li>When sitting on a study team, lead the study team to develop a cross-functional, integrated study plan and create initial study budget. Review study feasibility assessments provided by the CRO(s), lead the CRO selection process and provide input into ARO selection.</li><li>Validate the study implementation plan provided by the CRO through to study close out and CSR writing. Ensure the timing of the major study milestones and the associated budget meet the needs of the overall development plan agreed to by the Global Project Team (GPT).</li><li>Lead site selection and site qualification discussions, kick-off meetings and study team meetings.</li><li>Oversee the CRO and provide timely input to ensure that the study is executed according to the agreed project plan. Complete a study risk assessment and ensure mitigation and contingency measures are prepared and implemented. Actively assess potential risks to the study and propose mitigation plans.</li></ul>CRO and Quality Oversight:<ul><li>Responsible for oversight of all CROs utilized within their therapeutic area. May represent Clinical Operations on the DS/CRO Joint Operating Committee. Work with Process Excellence and Risk Management to ensure oversight plans are in place for all studies falling under their responsibility.</li><li>Design, update and implement appropriate innovative and best-in-class procedures and SOP's related to clinical study oversight and execution.</li><li>Work with TMF Operations to ensure a state of inspection readiness for all TMFs and ensure quality expectations are met.</li><li>When sitting on a study team, responsible for management of CRO(s) performance to ensure adherence to scope of work within timelines and budget at an overall study level. Specifically, track major study milestones and monitor overall operational performance metrics through the life of the study. Identify issues early and propose solutions. Whenever possible, resolve issues that have been escalated or if warranted, take issues to the appropriate governance committee.</li><li>Create the budget at study start up, and monitor the overall agreed budget against trial progress. Work closely with internal and external stakeholders to ensure team awareness of the CRO scope of work (to minimize unwarranted change orders) and budget, so both can be managed appropriately.</li><li>Provide oversight of the CRO to ensure compliance with Daiichi Sankyo's quality measures. Leads the creation of the Risk Identification and Management Log (RIM Log) and other risk related plans and ensure study team adherence and utilization. Be aware of and be able to predict deviations or potential noncompliance concerns (at a protocol level, site level, study level) and rapidly resolve or escalate to appropriate Governance Committee. Analyze CRO performance trends within a clinical study or across several studies and resolve or escalate accordingly.</li></ul>People and Resource Management: Responsible for resource management within their therapeutic area. Management requires review of resources against development pipeline to identify areas of resource gaps or excess. Management includes appropriate use of DS employees and contractors to ensure adequate staffing at all times. This position may require the supervision of functional and/or direct reports. In addition to providing instruction, direction of daily activities in support of goals, the supervisor will conduct a performance evaluation against development goals and career path requirements for their direct reports. The supervisor should coach and guide their functional and/or direct reports in support of their development needs, and facilitate conflict resolution on their behalf Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education: <ul><li>Bachelor's Degree in the Sciences required</li></ul>Experience: <ul><li>10 or More Years relevant experience required</li><li>4 or More Years with a MS/MPH preferred</li><li>4 or More Years with PharmD/PhD preferred</li><li>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). preferred</li><li>CRA experience preferred</li><li>Time spent directly in a medical environment (e.g. as a Study Site Coordinator) is also considered relevant. preferred</li></ul>Travel:<ul><li>Ability to travel up to 20% In-house office position that may require some travel (domestic or 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.

Director, Global Clinical Operations

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, Imaging Project Management will be a member of the Functional Excellence Team in Global Oncology Development, working with cross-functional stakeholders to develop and execute the imaging strategy for early and late phase study protocols with imaging-based endpoints. The Director will be a main point of contact for the processes associated with Blinded Independent Central Review (BICR) vendors. Responsibilities:<ul><li>Protocol Development: Ensure appropriate imaging strategy (collect-and-hold versus full analysis) applied to study; author imaging sections of protocol; conduct periodic review of standardized protocol language to ensure alignment with current practices and literature; facilitate review of imaging charter, site manual, and communication plan</li><li>Vendor Engagement: Partner with Procurement and Alliance Management to perform vendor feasibility (RFI); partner with imaging vendors to standardize documentation, processes, and software applications to ensure consistency across the DS oncology portfolio</li><li>Quality Monitoring: Screen and select Independent Radiology and Oncology physicians (readers) for assignment to studies based on indication specific BICR experience; regularly monitor reviewer metrics for quality control in support of clinical trial endpoint data, and collaborate with Imaging CRO on remediation efforts to ensure independent reviewer calibration; maintain database of readers for assignment to similar studies/indications</li><li>Cross-Functional Collaboration: Collaborate with clinical team and/or statistical team to perform routine review of BICR data to ensure expectations are met with respect to data points being collected and appropriate response assessment outcomes; foster relationships with Operations Leads to identify efficiencies in processes related to scan submission to vendors and communication pathways to ensure deliverables and timelines are met</li><li>Scientific Engagement: Develop BICR read processes (e.g., eligibility, verification of disease progression) and edit checks for incoming response assessment data to identify errors programmatically; Investigate trends in site/central discordance in response assessments</li><li>Promote Functional Excellence: Design workflows, identify dependencies, milestones in the conduct of imaging portion of study within internal teams and vendors; perform Lunch and Learn trainings on BICR processes; solicit feedback from stakeholders within the organization to identify pain points, gaps, or opportunities for improvements</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 preferred and</li><li>PhD preferred or</li><li>MD preferred</li></ul>Experience:<ul><li>5 years of experience in imaging operations in oncology clinical development of both early and late phase clinical trials, including development and review of imaging section of the protocol, imaging charter, site manuals, and communication plan</li><li>Deep knowledge of implementation of oncology</li><li>At least 15 years in Clinical Research in combined pharmaceutical company and Contracted Research Organization (CRO) environment required and</li><li>4 or More Years of tumor assessment performed by (1) investigator/site and (2) BICR for both solid tumors and hematological malignancy</li><li>Extensive experience in BICR reader selection and performance monitoring and improvement</li><li>Deep understanding of collection and QA of imaging and related non-imaging data from sites to Imaging Vendor to Sponsor</li><li>Clear comprehension of computation and programming of BICR output (e.g., ORR, PFS, DoR)</li><li>Familiar with good documentation practices and record retention processes, particularly those used in Biostatistics and Data Management groups</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, Imaging Project 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: Serves as a primary source of medical accountability and oversight for one or more clinical trials &bull;Matrix management responsibilities across the internal and external network &bull;Manages Phase 1-3 studies (depending on assignment) with demonstrated decision-making capabilities &bull;Provides medical and scientific expertise to cross-functional DSI colleagues Responsibilities: Medical Monitoring: For studies in which Medical Monitoring activities are conducted in-house:<ul><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 (IDRP)</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 (SME) 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>Maintains 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>of 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, Endpoint Committee, 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 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 in planning and executing the overall publication and clinical communication strategy (overall or at the individual trial level), providing input to key external presentations, if applicable.</li><li>Contributes to and serves as the medical point of expertise in key HA 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 or equivalent required and</li><li>Postgraduate training in TA or related specialty preferred</li></ul>Experience: <ul><li>4 or More Years industrial 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.

Director, 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: This role is part of Daiichi Sankyo Translational Science Oncology department and will participate in research towards utilizing digital and computational pathology approaches and related biomarker data for understanding drug mechanism of action, patient selection and patient enrichment strategies for programs across the clinical portfolio. The successful candidate for this position will provide technical and scientific leadership in conducting histopathology and digital & computational pathology-based biomarker data analysis in support of translational science goals for oncology programs. The primary datasets will be derived mostly from analysis of Daiichi Sankyo sponsored clinical trials as well as pre-clinical data and may require bringing in additional sources of information. S/he will contribute to the translational and precision medicine strategies by influencing methodologies, technologies and analysis utilized in translational research and deliver insights that will influence and drive clinical development decision-making. Besides global Bioinformatics teams, this role will require collaborating across functions and geographies with Translational Science Strategy leads, Clinical Pathology, Clinical Biomarkers and Biostats. Additionally, S/he will identify and interact with key external experts and collaborators and monitor progress toward goals of research programs. Responsibilities<ul><li>Collaborate with translational scientists to develop translational study and analysis plans supporting biomarker research and development across our pipeline with focus on digital and computational pathology approaches,</li><li>Plan and deliver bioinformatics and correlative analyses to project teams in support of the translational science and digital and computational pathology goals.,</li><li>Collaborate with the cross-functional stakeholders to shape our ecosystem both by improvements in data and analysis platforms as well as processes for data and analyses delivery.</li><li>Evaluate data resources and analysis methodologies, initiate or participate in collaborations to enhance bioinformatics and translational research capabilities globally at DS relating to digital and computational pathology.</li></ul>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education<ul><li>PhD, MD or master's degree in STEM or related areas required</li></ul>Experience:<ul><li>7 or more years with PhD or MD, 12 years with master's degree required.</li><li>Experience in bioinformatics / computational biology required</li><li>Experience in oncology drug development at a biopharmaceutical company in Translational Sciences or Medicine preferred</li></ul>Competencies:<ul><li>Expertise in correlative and integrative analyses using data from digital and computational pathology (IHC, H&E) and clinical outcomes data for informing patient selection and patient stratification approaches. Expertise in datasets and methods in areas such as spatial profiling, and digital and computational pathology. Knowledge of various bioinformatics and statistical methodologies utilized in biomarker research.</li><li>Experience in correlative analysis using data from genomics platforms (e.g. Gene panels, WGS/WES sequencing, RNA sequencing etc.) as well as other clinical biomarkers (e.g. IHC, Cytokine profiling, Flow cytometry etc.) and clinical outcomes data.</li><li>Hands on programming skills using R, Python or other commonly used scripting and programming languages in bioinformatics and developing dashboards to share results. Knowhow of clinical data formats and commonly utilized biomarker data formats for digital and computational pathology.</li><li>Excellent working knowledge of cancer biology, cancer genomics/genetics and related data resources and application of various omics and digital pathology technologies to understand disease and disease heterogeneity and its application in enabling translational research.</li><li>Excellent collaborative and communication skills in cross-functional setting</li></ul>Travel: 0-10% 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.

Director, Translational Bioinformatics, Digital and Computational 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 Director US Medical Affairs (USMA) Oncology, under the direction of the Senior Director, USMA Oncology (US Medical Affairs team lead for compound), is responsible for assisting with defining compound/program medical strategies and for leading select medical affairs projects within a specific compound or indication. The role is primarily responsible for US Medical Affairs Strategy and overseeing execution of medical activities for assigned indication(s) and asset(s) and will have the responsibility of managing multiple direct reports. Responsibilities - Leads the development of the US Medical Affairs strategy and execution of the US Medical Affairs plan for select indications/projects related to evidence generation, medical information and internal education, publications, scientific exchange and external data communication, and stakeholder scientific engagement. Responsible for managing budgets and resources for the assigned medical affairs plan activities, in collaboration with Sr. Director. - Leads medical readiness activities for market launches. This includes strategic partnerships with the brand team, HEOR (Health Economics and Outcomes Research), RD (Research Development), FMA (Field Medical Affairs), MIE (Medical Information and Education) and global functions as necessary to create and implement strategies that support launch. Provide medical support/input into commercial and market access discussions for select indications. - Provides medical leadership in interactions with key external stakeholders including scientific leaders, payers and societies; lead Scientific Engagement activities such as planning advisory boards, managing individual stakeholder interactions and peer to peer discussions, congress engagement activities, and collation of insights for select indications related to the compound. - Responsible for scientific communications and publications; interpretation of clinical data; ensuring consistency of clinical content and scientific statements across materials; training or communication of emerging data (internal or competitive), such as congress updates and development program highlights; and budget and forecast accuracy - In a matrix environment, represents US interests and business needs in shaping development and life cycle management strategy for select indications/projects. Reviews Externally Sponsored Research (ESRs) and may serve as deputy regional medical lead in Global IIS Review Committee meetings. May serve as medical lead for select company-sponsored evidence generating studies/projects. Manages all medical aspects such as study document development and drives execution for assigned projects in collaboration with USMA Clinical Operations and other cross-functional and regional stakeholders. 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, Ph.D., MD, DO, or equivalent) in a medical/ scientific area is required. Experience in oncology therapeutic area is required. Experience Qualifications - 10 or More Years 10 or More Years overall related experience or commensurate education/experience required - 4 or More Years experience in pharma at local, regional and/or Global level preferred - Excellent knowledge of current clinical practice in Oncology / Hematology or other relevant disease area preferred - knowledge in and understanding of medical activities (including scientific communications, medical information, MSLs, and HEOR), relating to the commercialization of oncology products preferred Travel Ability to travel up to 20% Standard office based physical demands, travel as 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, U.S. Medical Affairs 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 Align and set strategic goals for Customer Insights & Market Analytics to ensure Daiichi Sankyo's future sales success across all partnered and in-line portfolio products. Directly shape how DSI will work and partner with sales leadership and global teams across, but not limited to, DSI, American Regent, Vifor, AZ, and Merck, develop key metrics to measure success for how teams work together to produce results for US OBD and improve upon our commercial position within the US. In addition, the individual will develop and oversee both the targeting, research and insights plans that compliantly motivate the field sales force, support brand objectives and help the company achieve its core business needs. This role identifies all go-to-market applications for all commercial customer facing entities. Determines if in-house or customer facing resources should be deployed, including level and investment. The Executive Director works with BD to evaluate and decide if commercialization assessments progress. This role is solely accountable for deal analyses and implementation of commercial partnerships. This role leads and certifies the call planning and targeting process to support the DSI portfolio and evaluates potential assets. The Executive Director, US Customer Insights & Market Analytics position will oversee both primary market research and secondary data analytics teams. Manage all day-to-day operations and represent the needs and interests of DSI with our partners to help ensure success for product sales. The Executive Director, US Customer Insights & Market Analytics will provide support to the VP, US Business Operations specific to sales force deployment. The position will also require the incumbent to be aware of environmental trends and act appropriately on behalf of DSI to drive ethical promotion of our products. Responsibilities - Execute on all brand and sales plans to achieve sales objectives for US OBD approved products and key milestones for pre-launch products. Ensure teams align field-facing resources to serve the needs of target customers in an ethical and compliant manner. - Leads and transforms the annual business planning cycles, to include: developing processes and controls for budgets, plans, and headcount efficiency. Provide ongoing strategic and tactical advice and counsel to Business Operations, Sales, Marketing, Market Access, and Medical Affairs. Oversee the development and execution of compliant call plans to ensure consistency with budget appropriations and support achievement of company goals. Assesses the implications to the 3-year plan and other internal planning cycles. - Oversee budget, manage team, and own operations for Market Analytics and Customer Insights. Adhere to and maximize budget for optimal business impact. Supervises, coaches, and leads development of direct and indirect reports to ensure high quality results. Responsible for the overall performance and development of all employees within scope, focusing on coaching, motivating and inspiring associates to accelerate performance. Partners with VP, US Business Operations and Human Resources Business Partner to hire, develop, train, and retain a highly productive and motivated team. Work directly with third party vendors to evaluate performance and ensure contracted service obligations are met. Ensure third party vendors operate with efficiencies and strategic excellence. - Solely responsible for the commercial evaluation of inline portfolio assessments. Determines and evaluates commercial feasibility including product assessments, market viability, commercial investment, go-or-no-go deals. Responsible for informing Head of US OBD and key cross-functional leaders. Accountable for meeting and exceeding all contract parameters defined, including the financial implementation. Informs DSI Corporate Finance and DSI BD and partners closely. - Leads the evaluation of all go-to-market assessments and resource deployment determinations to align deliverables and provide recommendations on 3-year planning horizon, informing decisions with enterprise-wide impact. 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 - MBA or Advanced degree/certificate preferred Experience Qualifications - 10 or More Years overall related experience required - 10 or More Years of progressive sales, marketing and or commercial experience preferred - 4 or More Years leadership experience required - Pharmaceutical Sales and/or Sales management experience preferred - Experience in Market Research/Customer Insights and Data Analytics required - Advanced analytical methods, a thorough understanding of anonymized patient-level claims data and AI/ML techniques required - Proven track record in developing strategic initiatives with cross-functional disciplines required Travel Ability to travel up to 30% 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, Customer Insights and Market Analytics

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 Executive Director, Head of Center of Excellence (CoE), Global Medical Safety will oversee a team of safety physicians and scientists across various regions, offering guidance and support to each product safety team in critical areas such as individual case medical review, risk management, aggregate safety reports, and translational medical safety. This role requires the individual to bring the latest knowledge in these fields, ensuring high quality and efficiency. This role will be responsible for recruiting and developing the CoE team, refining or expanding its scope as the organization evolves in collaboration with other departments, and coordinating and prioritizing CoE resources for key programs. The role will also provide senior safety leadership and guidance on complex issues across the DS portfolio, including both compounds in clinical development and marketed products. The successful candidate will work in collaboration with sub-functions within CSPV and other departments across the company to ensure alignment. This senior role will involve close cooperation with other CSPV Leadership to develop strategy and harmonize processes that support the department's objectives. Responsibilities<ul><li>A member of DSI CSPV and Global Medical Safety leadership team</li><li>Develop or leverage expertise to support the creation of strategies and objectives for DSI CSPV and Global Medical Safety, including the CoE, ensuring alignment with the broader DS goals and objectives.</li><li>Collaborate with other leadership members to manage DSI CSPV HR-related matters, including performance reviews and departmental talent development.</li><li>Line management and senior leadership accountabilities in CoE</li><li>Lead a team of safety physicians and scientists by recruiting, developing, and retaining talent; coach, mentor, and influence team members within the CoE as well as other members of CSPV.</li><li>Ensure sufficient resources for key programs; collaborate closely with team leads in other regions to coordinate resources and talent development.</li><li>Ensure the full implementation of all CSPV strategic change initiatives within the CoE.</li><li>Refine and expand the global roles and responsibilities of the CoE as the organization grows and business needs evolve.</li><li>Ensure the CoE's continuous operational execution and excellence by applying best practices in accordance with regulatory requirements and guidelines worldwide, and in alignment with the CSPV governance and operating model.</li><li>Provide medical and scientific guidance to teams</li><li>Provide oversight and guidance for all medical and scientific activities within the CoE group, including the global efforts of teams in other regions. May directly manage complex safety issues related to individual case review, risk management, translational medical safety, and aggregate safety reports, including: ensure that adverse events are evaluated accurately and promptly, including clinical assessments to determine the seriousness, causality, and expectedness of the adverse event in relation to the drug. Ensure all relevant data and findings are incorporated into comprehensive safety reports as required by all regulatory authorities.</li><li>Ensure a robust risk management process with appropriate tools, serving as the expert in risk management for product safety teams.</li><li>Prioritize areas for translational medical safety and make a meaningful impact on clinical development at the program level.</li><li>Lead projects to enhance processes within CSPV, including the CoE, and/or to develop and implement new technologies and approaches at a global level.</li><li>Maintain a high level of understanding and awareness of internal and external scientific and regulatory trends in these four areas, and communicate these insights to leadership and team members as appropriate.</li><li>Establish networks with other teams/functions and external stakeholders to stay informed about new developments, leverage opportunities, and share best practices.</li></ul>Compliance responsibilities<ul><li>Ensure that all activities of the CoE group comply with Good Clinical and Pharmacovigilance Practices, as well as all relevant internal and external regulations and standards.</li></ul>Basic 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>Must have a MD in relevant scientific discipline is required, a combination MD/PhD strongly preferred</li></ul>Experience Qualifications<ul><li>10 or more years of relevant pharmaceutical industry experience in clinical development or clinical safety/post marketing safety in the pharmaceutical industry required</li><li>Must have at least 4 or more years of pharmaceutical industry expertise in clinical safety/post marketing safety</li><li>Demonstrated people management/leadership experience (at least 5 years leading direct reports)</li><li>Proven experience leading safety physicians and scientists in individual case medical review, aggregate reporting, risk management, and/or translational research</li><li>Must have excellent communication, project management, writing and analytic skills</li><li>Must be organizational leader with ability to influence others and collaborate cross functionally.</li><li>Must have in-depth understanding of the most recent technical and regulatory advancements</li></ul>Travel Ability <ul><li>Must be able to travel both domestic and international 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, Head of CoE, Global Medical Safety, 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. Job Summary:<ul><li>Required experience in business analysis and process designs in TMF and other systems/area in the R&D clinical space.</li><li>Experience in Veeva clinical platform, especially in clinical trial management.</li><li>Experience in working in an outsourced environment (from a sponsor or a CRO side).</li></ul>The Manager, Business Systems & Ops is responsible for optimizing business processes involved in pharmaceutical R&D using technology solutions/services and providing the analytical support to make them efficient, effective and/or improve the overall quality. This role also proactively collaborates with the global development functional groups and other internal GDIM (Global Dev Information Management) team members globally to gain more understanding of any specific nuances that Daiichi Sankyo may have in their business processes and use that to produce proposals to drive efficiency, compliance, and innovation. A primary focus of this role is on processes or sub-processes in different domains where there are gaps and there is a need to address them through a people/process/technology/ or data framework. Depending on the magnitude of the specific projects, this role will require the ability to operate independently or collaborate with one or more Business Analysts (BA) and/or Business Process Experts (BPE) assigned to their specific project. This role regularly collaborates with leadership, business process owners, GDIM team members, and information technology leads and specialists to understand the capabilities required to optimize business processes, to assess the current state, define a desired future state, and to develop or contribute to the business and technology artifacts associated with the implementation, change, and operation of business systems. Their primary objective is to improve operational efficiency, streamline processes, and drive innovation within the R&D function. This role will be responsible for influencing key stakeholders by collaborating with other functional SMEs. Responsibilities: Business Analysis:<ul><li>Lead or collaborate on discovery concept phase activities including (but not limited to) current state assessments, key stakeholder interviews, surveys, policy procedural reviews, document analysis, requirements workshops, and use cases.</li><li>Lead or collaborate on analytical and critical evaluation activities including (but not limited to) to-be process engineering, definition of process roles and responsibilities, identification of test scenarios test cases, creation of training plans training materials, authoring of procedural documents, and work aids for efforts involving the implementation of, or changes to, information technology business systems.</li><li>Proactively communicate and collaborate with external and internal customers to analyze information needs and functional requirements.</li><li>Critically evaluate information gathered from multiple sources, reconcile conflicts, decompose high-level information into details, abstract up from low-level information to a general understanding, and distinguish user requests from the underlying business needs.</li></ul>Business Process Reengineering:<ul><li>Analyze existing RD processes, identifying bottlenecks, and developing strategies to improve efficiency, reduce costs, and enhance productivity.</li><li>Ensure that RD processes align with regulatory requirements and industry standards, such as Good Clinical Practice (GCP) and Good Laboratory Practice (GLP).</li><li>Responsible for proactive and effective business process mapping methodology for the development of To-be and As-Is maps and requirements. Define As-Is" optimized To-Be" business processes to develop requirements and business model changes - provide into the overall harmonized software process design (Business Process Guide).</li><li>Manage (develop / update / review and approval, etc.) business SOPs as needed and as impacted by project.</li></ul>Project Definition, Planning, and Management:<ul><li>Develop or collaborate in the development of a Problem Statements, Business Cases, High-level Project Plans, Project Charters, and Project Proposals to frame each business system opportunity or problem, identify the benefits to be realized, and define the anticipated effort and timeline for each proposed project or significant system change.</li><li>Assist project leads and project managers in planning projects, establishing work plans, determining the anticipated effort, estimating resource requirements, and identifying required deliverables.</li><li>Assist project leads and project managers in tracking, communicating, and reporting on project status, as well as developing materials for presenting various aspects of proposed or in-progress projects.</li></ul>Relationships Collaboration:<ul><li>Collaborate with other GDIM team members globally and external RD function SMEs to work in a harmonized fashion across areas of specialization to support project and RD objectives.</li><li>Build and maintain close relationships with subject matter experts, information technology colleagues, business leads, vendors and external resources in executing projects or other initiatives.</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 Computer Science, Life Science, Engineering, Business Administration or a related discipline or equivalent work experience required Experience Qualifications</li></ul>Experience:<ul><li>Minimum of 5 years of experience within life sciences supporting the delivery of GXP validated global business systems serving cross-functional stakeholders is required required</li><li>Demonstrated experience within or supporting Research & Development processes, roles and systems is required required</li><li>Demonstrated experience in translating business needs into technical solutions and technical considerations into business language is required required</li><li>Demonstrated experience working with one or more R&D systems either on the IT or Business side is required required</li><li>4 or More Years Excellent oral and written skills are required required</li><li>Proven ability to work in a global and highly matrixed environment is preferred 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 - Business Systems & Ops Management - R&D Clinical

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: Drafts development plans, protocol profile, protocol, and clinical sections of submission documents under guidance of CSL and/or Medical Monitor. Represents Clinical Development on Study Team and collaborates as team member with other functions, ARO, CRO. Provides scientific input to Clinical Operations and other functions. This position provides critical support to the CSL and Medical Monitor in the execution of Clinical Development functions. Responsibilities:<ul><li>Study Strategy: Drafts development plan under guidance of CSL and/or Medical Monitor. Contributes along with CSL and/or Medical Monitor to development of study design to meet study objectives, development of biomarker/PK strategy in collaboration with Translational Medicine and Clinical Pharmacology (TMCP), providing strategic direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical Operations on SDV plan. Performs literature review and creates reference list for study.</li><li>Study Planning: Contributes to clinical trial planning including identification of potential risks to study deliverables; development of contingency plan; development of protocol profile, protocol, and ICF template; selection of ARO, CRO, and members for DSMB and/or adjudication committee; development of charters for study committees (e.g., Executive Committee). Provides input to Clinical Operations on monitoring plan (e.g. data fields to be SDV'd) and to Biostatistics on Statistical Analysis Plan (SAP).</li><li>Study Execution: Reviews patient demographics, enrollment, retention and protocol compliance for consistency with study strategy; reviews emerging clinical data regularly; performs quality assessment of Tables/Listings/Graphs before database lock; collaborates with lead statistician on SAP update, as needed. Provides input to Clinical Operations on site issues. Contributes to development of CSR.</li><li>External Collaboration: Consults with internal experts and external KOLs for protocol development; provides input on CRO and ARO Scope of Work and budget; participates in study team meetings with CRO and ARO; establishes effective communication with CRO, ARO, and vendors. Meets with commercial group regarding new indications for Life Cycle Management.</li><li>Additional non-study related activities: Clinical Development involvement in due diligence activities related to in-licensing and acquisitions. Performs literature review related to new indications for Life Cycle Management.</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 or equivalent preferred</li><li>PharmD or equivalent preferred</li><li>PhD or equivalent preferred</li><li>Postgraduate training in TA or related specialty, or equivalent preferred</li></ul>Experience:<ul><li>1 or More Years with PharmD, PhD and relevant clinical experience preferred</li><li>4 or More Years with master's degree and relevant clinical experience 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, Clinical Science

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 Manager, Data Management is accountable for end-to-end delivery of clinical data management services for assigned studies, collaborating with study teams, CROs, external vendors, and partners to ensure high quality deliverables are on time to support drug development processes and global submissions. This position also partners with internal and external stakeholders to optimize Data Management technology, processes, and standards. This position may manage multiple studies concurrently. This position will manage DM resources of assigned studies. This position requires a strong working knowledge of clinical data management processes, Electronic Data Capture (EDC)/related applications, industry standards, and technical skills in working with data received from CROs and other external vendors. This position requires strong verbal/written skills, analytical, organizational, and interpersonal skills and is able to work effectively with people at different levels and from different disciplines and cultures. Additionally, this position requires knowledge of clinical operations, biostatistics, and relevant regulatory requirements. This position requires experience working on multiple phases within the medical device and/or pharmaceutical industry in one or more complex disease areas. This position requires experience in continuous improvement, project management, change management, and risk management. Responsibilities: Leadership, Direction, and Strategy: - Establishes Data Management deliverables and expectations at the study level. - Proactively identifies and manages risks to data quality and/or timelines at the study level and escalates issues to the DM program lead. - Will manage DM resources of assigned studies; provides FSP/Vendor oversight for end-to-end Data Management activities. - Acts as a core member of the Study Team and collaborates with other line functions to achieve study deliverables. - Is an ambassador and Subject Matter Expert (SME) for DM.  Participates in audits and inspections as the DM SME for the study. Project Management: - Is accountable for the conduct of Data Management activities for assigned studies (e.g., study startup, study conduct, study closeout, and monitoring adherence to quality expectations and timelines. - Is responsible for proper planning of DM resources for assigned studies. - Complies and ensures compliance of DM resources of assigned studies and vendors with the protocol, Policies, SOPs, external/internal standards, program standards, Good Clinical Practices (GCPs), applicable regulatory requirements, and other relevant guidelines. - Is accountable for Data Management deliverables meeting/exceeding study team expectations regarding quality and time. - Ensures Data Management documentation is filed/archived according to applicable Daiichi Sankyo and regulatory requirements Functional Expertise: Study Start-Up: - Participates in Study Team's start-up meeting to determine technology and study-specific data requirements. - Meets with assigned DM staff and external vendor(s) to discuss data management responsibilities, timelines of deliverables, and development of study plans/documents. - Reviews and approves study timeline for all DM study start-up, conduct, and close-out activities and ensures alignment with program timelines. - Contributes feedback to authors of other cross-functional study documents such as the Clinical Protocol, Clinical Monitoring Plan, Statistical Analysis Plan, SAE Flow Plan, Medical - Management/Medical Data Review Plan, Lab Plan, Randomization (IXRS) Plan, and Protocol Deviation Plan to ensure successful data collection, cleaning, and evaluation of study results and safety data reporting. - Identifies need for and requests new study data standards; ensures consistency of incorporation of these and other DSI data standards across assigned studies. - Reviews and approves DM study start-up documentation such as the CRF, eCRF completion guidelines, edit check specifications, Data Management Plan, Data Review Plan, electronic file transfer specifications for all vendors, study-specific listings, reconciliation specifications, and the UAT Plan ensuring incorporation of DSI data collection and cleaning standards. - Participates in cross-functional review of data collection forms/methods (i.e., eCRF, ePRO, external systems/other data collection tools) and data cleaning/review tools for assigned studies; checks for consistency with program standards. - Reviews User Acceptance Testing Plan for database, edit checks, reconciliations, and listings and oversees testing, validation, and implementation activities to ensure quality deliverable. - Specifies to DM study resources the DM documentation list and location for study filing. - Reviews and approves study-specific data management SIV/IM training slides for investigator meetings and site trainings. - Authorizes release of database/EDC system into production. Study Conduct: - Ensures DM activities are executed according to timelines and quality expectations through collaboration with internal and external stakeholders (i.e., clinical data cleaning, external data transfers, SAE reconciliation, local lab data processing, medical coding, report specification review, study files management) - Oversees data review process for assigned studies and performs data quality checks on an ongoing basis to ensure data quality and data integrity of clinical trial database and externally generated electronic data files. - Reviews and manages updates to study DM documentation, specifications, and deliverables. Discusses and disseminates changes in planned data requirements and timelines to assigned DM resources of assigned studies and vendors. - Evaluates impact of study changes and communicates required changes to the relevant study team members and/or assigned DM resources. Ensures appropriate changes are reviewed, approved, and implemented. - Reviews study metrics, status reports, and adherence to timelines to ensure study expectations are met for data quality and timeliness. Identifies data trends, risks, and issues and determines and coordinates mitigation activities; escalates issues to DM Program Lead as needed. - Attends study team meetings and provides information on risk mitigation as needed. - Manages the review and approval of data deliverables for support of statistical analyses. - Ensures the data files received from external vendor(s) are reviewed for compliance with the data specifications, data transfer plan, and external data standards (wherever applicable). - Ensures filing of DM documentation and approval/signature forms on an ongoing basis within study's Trial Master File (TMF) according to applicable Daiichi Sankyo and regulatory requirements. Study Closure: - Oversees database lock preparation and ensures activities on checklist are completed. - Obtains study team agreement on readiness for database lock; collects all appropriate signatures on the Clinical Database Lock Authorization Form. - Notifies study team that database is locked; ensures final datasets are posted to the appropriate data repository folder. - As needed, coordinates cross-functional activities for evaluation for database unlocking and re-locking. - Reviews and endorses study's TMF completeness and correctness by performing functional QC of filed DM documentation. - Oversees and coordinates final end-of-study procedures (EDC site data provided for distribution to Sites, database archived and decommissioned). Operational Efficiency / Continuous Improvement: - Provides comprehensive data management expertise to study teams to optimize study-specific clinical trial processes. - May participate in process improvement initiatives. 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 (or equivalent experience) preferred - Bachelor's Degree in life sciences or related field (or equivalent experience) required - RN in life sciences or related field (or equivalent experience) preferred Experience Qualifications: - 5 or more years in Clinical data management and/or related industry work experience in a medical device, pharmaceutical, or biotechnology company, or similar environment (e.g., CRO); oncology, immunology, or complex disease clinical trial experience 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.

Manager, Data Management

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 100 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. 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 Oncology Territory Manager represents Daiichi Sankyo to assigned customers. The Oncology Territory Manager represents the assigned product, and its approved indications, providing approved disease state and product information, and resources to physicians and other customer stakeholders. Responsibilities:<ul><li>Represents the assigned products to health care professionals in assigned sales territory.</li><li>Achieves or exceeds sales objectives through promotion of the assigned product features and benefits to assigned customers.</li><li>Develop and execute comprehensive business plans.</li><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><li>Maintain expert understanding of the relevant disease state(s), assigned Daiichi Sankyo brands, and competitor products.</li><li>Completes all assigned training.</li><li>Serves as a disease state expert and provides a high level of product expertise and customer service for all accounts.</li><li>Communicates on a regular basis with District Manager, internal and co-promote peers and discuss issues and opportunities.</li><li>Builds relationships with Daiichi Sankyo customer base and key opinion leaders. Communicates products approved indications, features and benefits in both individual and group settings.</li><li>Meet all administrative expectations and standards, including budgets, reporting, and communication.</li><li>Maintains a current key customer target list, submits regular updates to the customer database and plans calls to meet goals.</li><li>Reviews territorial reports with District Manager and learns how to use reports and databases as instruments to achieve assigned goals.</li><li>Submits completed reports on-time, and communicates matters that are relevant to the marketplace to the District Manager.</li><li>Maintains all equipment and territorial records in the prescribed manner.</li><li>Utilizes sales force automation system and other equipment to enhance impact of sales call and territory management.</li><li>Adhere to compliance and operating principles and expectations.</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></ul>Experience Qualifications:<ul><li>4 or More Years of sales/marketing experience in the pharmaceutical or medical industry required</li><li>4 or More Years of oncology therapeutic experience strongly preferred</li><li>1 or More Years additional therapeutic experience in diverse roles - training, marketing, market access preferred</li><li>Oncology product launch experience preferred</li><li>Copromotion experience a plus</li><li>Strong verbal and written communications skills</li><li>Proficiency in MS Word, Excel, PowerPoint and Outlook</li><li>Must be able to travel approximately 40% to 60%</li><li>Must have a valid driver's license with a driving record that meets company</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.

Oncology Territory Manager, Breast - Atlanta East

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 Oncology Territory Manager represents Daiichi Sankyo to assigned customers. The Oncology Territory Manager represents the assigned product(s), and their approved indications, providing approved disease state and product information, and resources to physicians and other customer stakeholders. The current weighting includes a majority focus on Acute Myeloid Leukemia and a smaller focus on Iron Deficiency Anemia. Responsibilities:<ul><li>Achieves or exceeds sales objectives through promotion of product features and benefits to our key accounts: Academic Institutions, Hospitals, Infusion Centers, Nephrologists, Hematologists, Hospitalist, PCPs/IMs, Bloodless Surgery, buying groups, distributors and wholesalers in assigned territory. As a secondary base, Cardiologists, Endocrinologists and Rheumatologists.</li><li>Builds relationships with our customer base and key opinion leaders by personally visiting them, educating and influencing physicians and healthcare providers to prescribe Daiichi Sankyo, Inc.'s promoted products. Communicates products approved indications, advantages, features and benefits in both individual and group settings.</li><li>Analyzes customer needs and interests. Maintains a current key customer target list, submits regular updates to the customer database and plans calls to meet goals. Carries out all sales and marketing programs. Maintains frequent correspondence with District Manager, co promotion team members.</li><li>Complies with applicable laws in providing healthcare providers with accurate information concerning Daiichi Sankyo, Inc.'s products.</li><li>Participates in assigned training and completing outside reading. Keeps abreast of the products, applications, technical service, market conditions, competitive activities, advertising, and promotional trends through the reading of pertinent literature and consulting with colleagues. Attends and participates in all required meetings and training programs.</li><li>Serves as a disease state expert and provides a high level of product expertise and customer service for all accounts.</li><li>Maintains all equipment and territorial records in the prescribed manner. Utilizes sales force automation system and other equipment to enhance impact of sales call and territory management. Reviews territorial reports with District Manager and learns how to use reports and databases as instruments to achieve assigned goals. Submits complete reports, on-time, and communicates matters that are relevant to the marketplace, competition and the marketing team to the District Manager.</li><li>Notifies the Medical Affairs Pharmacovigilance immediately of any product complaints as per SOP 805.21,'Reporting Adverse Events (AEs) and Product Quality Complaints (PQCs).'</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></ul>Experience Qualifications:<ul><li>4 or More Years overall pharma or healthcare related experience required</li><li>1 or More Years sales/marketing experience in the pharmaceutical or medical industry required</li><li>specialty, rare disease, and/or oncology experience strongly preferred</li><li>experience selling in complex environments preferred</li><li>Ability to travel up to 60%</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 .

Oncology Territory Manager, Hematology and Supportive Care - Jersey City

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 Supports the Daiichi Sankyo global locations by administering CI-LIB's content portfolio. Assists in selecting, procuring, and managing information resources, with careful consideration of business needs, cost efficiencies, and organizational priorities. Primary content liaison for data, information, and knowledge resources. Responsibilities<ul><li>Continue to monitor marketplace trends for information resources, including the evaluation and comparison of tools; partner with Procurement to negotiate with content providers, maximizing our support of regional and global business needs. Serve as a liaison with vendors for user access and coordination.</li><li>Manage process to maintain existing and new content, manage their contracts and financial administration, and work with users through change management.</li><li>Leverage advanced tools, such as PowerBI and AI, to provide data analysis and visualization, supporting the CI-LIB team through projects, initiatives, and evolving work to meet stakeholder needs.</li><li>Develop and advance methods to continuously assess the needs of the organization and ensure business alignment for information resources-locally, regionally, globally.</li><li>Analyze content usage and provide meaningful evaluation of the content portfolio based on internal key performance indicators (KPIs); develop strategies to maximize ROI. Leverage BI capabilities in RightFind.</li><li>Maintain a governance model for information resources licensed and a financing model for chargebacks and allocation. Maintain resource map of information services licensed, including funding thereof for budget tracking and reporting.</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 in Business Administration, Finance, or Procurement - Required</li><li>Master's Degree in Library / Information Science or a Life Science - Preferred</li></ul>Experience Qualifications<ul><li>4 or more years' experience in a corporate setting, with emphasis on content licensing and procurement - Required</li><li>Experience in the pharmaceutical industry - Preferred</li><li>Experience working in or with a library - Preferred</li></ul>Travel<ul><li>Ability to travel up to 5%</li><li>Ability to participate in early morning or late evening teleconferences with international colleagues</li></ul>Equal Opportunity Employer 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 Associate, Content Portfolio 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 Sr Director GPM&L is accountable for delivering an integrated drug development strategy and tactical plan including options analysis of team's proposals in partnership with a Global Team leader for high complexity projects/programs. Works effectively across organizational lines to ensure delivery of projects within cost, time and quality requirements. As a leader in GPM&L this position is also responsible for developing PM talent and may also manage a team of PMs. This position may be assigned to provide leadership to a therapeutic area (TA) or significant business collaboration and ensure effective PM resourcing to projects within the portfolio. As a member of the GMP&L leadership team this position is also responsible for developing and executing departmental objectives as well as supporting the global R&D organization in identifying organizational process gaps, developing and implementing solutions to help improve or optimize organizational efficiency and decision making. Responsibilities: Project Responsibilities:<ul><li>Independently manage or lead strategy development for high complexity drug development projects/programs. Manages the Global Project Team(s) in partnership with the Global Team Leader to drive strategy development and create an integrated product development plan and timelines. Ensure execution of overall plan and annual goals.</li><li>Responsible for developing and maintaining a high performing team.</li><li>Generate critical path analyses and lead scenario planning with GPT to select best option understanding cost and timeline implications.</li><li>Resolve complex problems and identify gaps in the project or organization.</li><li>Mobilize others to gain alignment with the most Sr leaders and secure resources for the project.</li><li>Accountable for the accuracy of project status in the project management information systems, for preparing scope change proposals and stage gate proposals for formal presentation to senior management. Can step in, as needed, on behalf of the Global Team Leader to deliver presentations to Sr Management.</li></ul>Departmental Responsibilities:<ul><li>Work independently within a matrix environment and coach, influence and mentor more junior PMs, Team members and project stakeholders.</li><li>As a TA lead or Lead on a Business Collaboration, will contribute to portfolio management by participating in global TA strategy committees and have an in depth understanding of project strategies/plans.</li><li>As a staff manager, responsible for coaching PMs on project-related issues including review of their Monthly Project Summary Reports and governance presentations. Responsible for talent development and ensuring that staff have actionable development plans and receive ongoing coaching and feedback.</li><li>Provide leadership to the Global PM function by supporting budget and resource management, annual goals setting as well as strategic direction for the department.</li><li>Identify and implement PM best practices for the broader GPM organization. Ensure organizational awareness of the Global Development Processes.</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 a scientific discipline with additional relevant experience is required</li><li>Advanced degree (i.e., MS, MBA or PhD) in a scientific discipline with additional relevant experience preferred</li></ul>Experience:<ul><li>10 or More Years in a drug development PM role or related role In Biotech or Pharmaceutical industry</li><li>10 or More Years Demonstrated success as a project manager/leader in planning and executing strategies for global drug development: early stage, late stage and life cycle management</li><li>10 or More Years Proven track record as a leader/influencer in a global role</li><li>10 or More Years Direct people management experience with ability to identify and recruit talent preferred</li></ul>Licenses and Certifications:<ul><li>Certified Project Management Professional (PMP)-PMI and/or training in project management preferred</li></ul>Travel: <ul><li>Ability to travel up to 5%</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, Global Project Management and Leadership

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 incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions in the West, in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. A key focus will be the oversight of and interactions with CROs and other external vendors to ensure studies are conducted according to the timeline, budget and objectives set forth by the Study team. The Clinical Study Manager role is primarily a tactical study delivery role, reporting into an Associate Director or above responsible for Operational Study Strategy. Responsibilities: Study Planning and Execution:<ul><li>Develop project cross-functional, integrated study plan to study start up (in-house) and validate and manage to the overall study plan provided by the CRO. Participate in site selection and site qualification with (study team and CRO).</li><li>Contribute to operational delivery aspects of the protocol and take a document review & coordination role for the protocol and amendments. Additional medical writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND.</li><li>Take responsibility to ensure meeting logistics, agenda and minutes of the clinical study team are in accordance with DS standards.</li><li>Act as the project manager of the clinical study team to liaise and coordinate with internal stakeholders to ensure cross functional integration and delivery of items (eCRF, EDC, IXRS, Quality Oversight Plan etc) per the study plan.</li><li>Oversee the CRO and provide timely input to ensure that the CRO-generated documents are created in a timely manner (communication plan, site monitoring plan, etc) ahead of study start.</li><li>Oversee CRO study start-up activities and coordinate with functional group to ensure that essential site documents are collected, and sites are initiated per plan. Coordinate with the CRO to prepare and execute meetings including Vendor kick-off meetings and investigator meetings and training.</li><li>Note that vendor management is not limited to the CRO, but includes ancillary vendors (e.g. translations, trial insurance, and central laboratory).</li><li>Work closely and oversee CRO activities for study execution with CRO on a task / operational level per the project plan. Oversee CRF completion and monitoring; Triage, resolve or escalate study issues to the supervisor.</li><li>Oversee CRO study close-out. Liaise with internal Functions to ensure drug destruction process is implemented. Liaise with CRO to support database lock and review of TLG before and after database lock.</li><li>Ensure DS internal tracking systems are updated (e.g. Global Project Management System, GPMS).</li></ul>CRO and Quality Oversight:<ul><li>Responsible for management of CRO(s) performance to ensure adherence to scope of work within timelines and budget at a task level. Specifically track short-term operational study timelines and monitor operational performance metrics throughout the study; Identify issues and propose solutions. Proactively assess potential risks to the study and propose mitigation plans.</li><li>Monitor study budget against progress and bring deviations to the supervisor. Review and approve Vendor invoices, including investigator grants and pass-through costs.</li><li>Provide oversight of the CRO to ensure compliance with Daiichi Sankyo's quality measures. Contribute toward the creation of the Quality Oversight Plan (QOP) and take a key role in ensuring study team adherence to the QOP. Specifically conduct quality oversight monitoring visits as outlined in QOP. Additional responsibilities include review and documentation of CRO-generated reports such as trip reports, protocol deviation reports, and analysis of site metric reports. Be able to identify areas of concern and either resolve or bring to the attention of the Delivery Lead. Coordinate and liaise with Daiichi Sankyo QA on audit activities</li><li>Provide oversight of the transmittal of trial and site level documents to the Daiichi Sankyo Document Control Center (DCC) in support of the Trial master File (TMF). Reconcile the CRO-generated TMF document trackers with the document archive. Identify and resolve issues with the reconciliation.</li></ul>Knowledge Management:<ul><li>Support Department in codifying existing knowledge and best practices; Prepare training in area of expertise. Make recommendations for areas of improvement and innovation (study, or departmental level). Educate the team on adherence to SOPs, GCPs and on best application of operational tools.</li><li>Work with supervisor to provide input into individual career development plan.</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 the Sciences required</li></ul>Experience:<ul><li>4 or More Years relevant experience is required with a BS preferred</li><li>1 or More Years with a MS./MPH preferred</li><li>1 or More Years with PharmD/PhD preferred</li><li>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. Time spent directly in a medical environment (e.g. as a Study Site Coordinator) is also considered relevant. preferred</li></ul>Travel:<ul><li>Ability to travel up to 10% In-house office position that may require occasional 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.

Senior, Clinical Study Manager

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