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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: Oversees multiple programs, alliances, large trials, such as global clinical development program for multiple product candidates with one or more indications or a single large program with multiple Ph II/III studies: Reviews regulatory documents from cross functional, holistic perspective. Provides senior level clinical representation at meetings with health authorities; Leads the creation of developmental and regulatory strategy; Accountable for performance of CROs; Routine interactions with senior management of CRO/ARO, as needed; Accountable for clinical development plans, protocol profiles and sections of key submission documents; Represents Clinical Development as team leader or as supervisor of team leaders; Accountable for Clinical Development input into commercial strategy including Translational Medicine and biomarker strategy; Thought partner in driving Business Development decisions in collaboration with External Scientific Affairs dept. Responsibilities: Clinical Monitoring Planning:<ul><li>Oversees and coordinates Sponsor oversight of CRO clinical Monitoring activities, including plan for internal communication and issue escalation with Clinical Study Lead (CSL).</li></ul>Clinical Surveillance:<ul><li>Documents ongoing Clinical Monitoring review of data for safety (with Clinical Safety Pharmacovigiliance) and quality at project level; Ensures global consistency of clinical Monitoring activities; Defines or contributes to department level surveillance activities across projects.</li></ul>Study Strategy:<ul><li>Interacts with leaders of each function to develop study strategy; Approves project or TA-level TM and biomarker strategy in collaboration with Translational Medicine and Clinical Pharmacology; Attends regulatory agency meetings and leads clinical strategy discussions.</li></ul>Study Planning and Execution:<ul><li>Develops prospective contingency plans for management of key risks across a large project or a portfolio of projects or across the Therapeutic Area; Clearly defines priorities and high-level execution plans across projects within and outside of Daiichi Sankyo; Supports effective communication and decision-making process cross-functionally and cross-regionally at department level.</li></ul>Study Outputs:<ul><li>For large studies/programs, consults on responses to IRBs and HA; Has strong understanding of statistics and study design principles applicable to primary and efficacy and safety endpoints in registrational trials to critically assess study conclusions.</li></ul>External Collaboration:<ul><li>Ensure continuous, effective alignment within / between CRO and vendors; For large, multiple indication project in late development, develops and leads Ad-Board with top tier KEEs for project level strategic advice; Develops and leads steering committee for Phase 3 registrational study; Consults with KEEs for advice on complex development or safety issues; Maintains and leads external collaborations and advisory panels at department level</li></ul>People Management:<ul><li>Assign staff with appropriate training and experience or arrange requisite support to lead large study teams, coordinate complex studies, lead projects, and/or ensure proper medical oversight; Monitor and manage direct report's performance in such roles, ensuring that there is proper understanding of task complexity and management of key risks; Participate in department's planning for staff and cross-functional staffing plans for the Therapeutic Area.</li><li>Additional non-study related activities: Routine senior management interactions; Influential relationship with top KOLs; Thought partner with Ext Scientific Affairs on Business Development activities for late-stage compounds; Committee member, in-licensing and acquisitions.</li></ul>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education:<ul><li>MD with relevant clinical experience required</li><li>Postgraduate training in TA or related specialty required Experience Qualifications</li><li>7 or More Years experience required</li><li>4 or More Years managing Clinical Development group 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.

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Executive Director, Oncology R&D, Global Clinical Lead

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 Sr. Director, Clinical Safety MD, will lead the development and implementation of integrated project/product risk management strategies aimed at achieving the optimum benefit-risk for Development Sankyo's development compounds through the Safety Management Team framework. This individual will use strong leadership and communication skills to successfully coordinate resources and ensure effective collaboration across development functions and sites. The individual assuming this role may function as a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology, and other departments to strategically manage benefit-risk throughout the lifecycle of the drug. Specific responsibilities will vary depending on the stage of development of assigned projects (i.e., Phase I through commercialization). RESPONSIBILITIES<ul><li>Depending on the status of development of the compound, lead and medical-scientifically direct a team of physicians and scientists responsible for a compound/product 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 other cross-functional teams 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.</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>Basic Requirements<ul><li>6 or more years of experience in the pharmaceutical industry, regulatory agency or academia, with exposure to drug development, clinical pharmacology, and/or epidemiology.</li><li>Expertise in oncology highly 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.

Senior Director, Clinical Safety MD

Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary This position will play a key role in bridging the gap between business needs and IT solutions. This position is responsible for overseeing the development, implementation, and maintenance of software systems that support business operations and objectives, with a special emphasis on HCP engagement systems. Requires excellent leadership skills, and a proven track record of managing cross-functions teams both in the US and globally, including strong collaboration with the IT functions. This role involves developing the HCP Engagements technology roadmap, leading innovation, communication strategies, identifying and managing KPI's, reporting strategies, and the implementation of system enhancements in areas of mobility, AI and RPA capabilities. In addition, this role will streamline business requirements, evaluate, and prioritize project and change request timelines, and ensures seamless integration with existing and upcoming internal and external systems. Responsibilities - Management of HCP Engagement Systems - Oversee the development and maintenance of HCP engagement systems to ensure they meet the needs of the business and regulatory requirements. - Collaborate with business units to identify opportunities for enhancing HCP (Health Care Professional) engagement through technology. Make strategic decisions that align with the organization's goals, ensuring that these initiatives provide significant value and contribute to the overall business growth and success. - Ensure systems are secure, reliable, and compliant with relevant healthcare regulations and standards. - Identify opportunities for system improvements and innovations that can drive business growth. - Work closely with business stakeholders to collect, assess, and prioritize requirements for system improvements, as well as new features and integrations. This collaboration extends to closely partnering with solution architects and implementation teams to devise scalable, efficient, and intuitive solutions on the Appian platform. - Responsible for ensuring data integrity and maintained optimal performance of all API and data integrations. - Design, develop and maintain a variety of reports, dashboards, and visualization that meet the needs of the different stakeholders within the organization. Ensure that all reports are clear, concise, and actionable. - Ensure system documentations are up to date with the latest functionality in collaboration work with vendors/support teams - Finalize own business requirements and ensure mapping to UAT scripts and lead data preparation for UAT execution. - Innovation and Enhancements - Lead initiatives to innovate and enhance existing systems, including areas like mobility, AI and RPA, capabilities. - Develop and implement communication strategies to ensure internal/external stakeholders are informed about new features and improvements. - Lead and manage our Innovation hub community to drive dialogue, innovation and foster a space for creativity, collaboration, process improvements and efficiencies. - Gather feedback from users to continuously improve system functionality and user experience. - Stay current with industry trends and emerging technologies to ensure we remain competitive and provide the proper customer experience for both internal and external customers. - Develop and lead the implementation of innovative concepts to life, from ideation to execution - Strategic Vision Road Map Development - Partner with both regional and global business along with DX/IT teams to develop, own and communicate a strategic vision and three-year technology roadmap for the information system including leveraging the Appian, DocuSign CLM platform and emerging technologies such a RPA, generative AI, and API-based integrations with internal and external systems like workday, Veeva, SAP, Cvent, among others. - Manage all reporting requirements from identifying KPI's, monthly/weekly reporting, team workload, data integrity and cleanliness to name a few. - Acting as the main liaison between business and DX/IT for user support and handling escalation and collaborating closely with the HCP Engagement IT Operations team to assess weekly status report and ensure timely and effective resolutions of issues. - Lead dialogue regarding system globalization with other DS regions, understanding their needs and factoring regional needs, laws, and requirements. - Collaborate with the Project Manager (PM), HCP Engagement IT Operations team and business stakeholders to manage user acceptance testing (UAT) session requirements. Oversee and approve all UAT crips and the implementation of new features. - Training Education - Manage the design and development of a comprehensive training program for internal and external users, including e-learning modules, workshops, and on-the-job-training. - Conduct training sessions, workshops, and seminars, both in-person and virtually, to deliver content to employees at all levels of the organization including 3rd party vendors. - Collaborate with subject matter experts to ensure accuracy and relevance of training content - Responsible for all PMRT submission of materials as required Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) - Bachelor's Degree Business management, computer science, Information Systems, or related field required Experience Qualifications - 4 or More Years 5+ years of relevant experience required - Managing operations and cross-functional teams required - Strong communication skills with focus on information translation between technical roles & business roles required - Pharmaceutical industry experience preferred - Experience with DocuSign CLM, generative AI, RPA (UiPath), SharePoint, MS Teams and Service Now preferred Travel Ability to travel up to 5%. Business meetings and conferences 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.

Manager, HCP Engagement Systems & Operations

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 This role offers the opportunity to substantially contribute to the mission of Daiichi Sankyo in leveraging our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. This role will work on one of our cutting-edge assets by effectively liaising, negotiating and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leading to successful approval of pharmaceutical applications for the company's growth, thereby accomplishing corporate goals. Responsibilities:<ul><li>Develop and implement US regulatory strategy for assigned project(s). Strategize and plan for FDA meetings.</li><li>Serve as the primary contact with FDA and liaise, negotiate and orchestrate meetings and teleconferences with FDA</li><li>Lead and prepare FDA submissions, including but not limited to briefing documents, breakthrough therapy designation requests, orphan drug applications.</li><li>Participate in global project team meetings (development and/or marketed products); provide regulatory support and guidance and manage day-to-day regulatory activities. Collaborate with all disciplines within the Daiichi Sankyo organization to obtain and/or provide information/data for regulatory filings.</li><li>May serve as the single regulatory representative on study teams.</li><li>Review and interpret regulatory guidelines.</li></ul>C ontinuing Education: Keep current with regulations and guidance documents; attend meetings, seminars, conferences on relevant topics; read journals, newsletters, scientific papers; research the answers to RA questions. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications: (from an accredited college or university)<ul><li>Bachelor's Degree required.</li><li>Advanced degree (e.g., Masters, PharmD., Ph.D., MD, JD) preferred.</li></ul>Experience Qualifications:<ul><li>10 or More Years in the pharmaceutical industry required.</li><li>8 or More Years in regulatory affairs</li><li>Experience in providing regulatory strategic input into the drug development process with thorough knowledge of the IND and NDA/BLA processes.</li><li>Ability to interpret and understand US regulations governing the pharmaceutical industry; general global knowledge of regulations, such as ICH is desirable. (s)NDA/BLA filing to FDA considered a plus.</li></ul>Competencies:<ul><li>Excellent oral and written communication skills, strong interpersonal skills; ability to work in a team environment; can work in high stress and deadline driven environment. Energetic, self-motivated and multi-task-oriented person.</li><li>Proactive, disciplined, organized and detail oriented. Attention to detail is required.</li><li>Demonstrates ability to think logically and objectively when identifying significant problems and opportunities.</li></ul>Travel:<ul><li>Ability to travel up to 30% 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.

Director, US Regulatory Affairs Strategy

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 Position leads statistical support for medium complexity studies including contributing to development of optimal study design, independently develop and execute statistical analysis plan and helps in 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 works on statistical methodology and leads/contributes to internal statistical workstreams to address various project needs. The position works closely with contract research organization (CRO) programmers and statisticians and collaborates with internal programmers in preparing analysis files and performing statistical analyses. Additionally, this position interacts with study teams, as well as statisticians and programmers at CROs. This position works under some supervision to solve complex study problems. Responsibilities<ul><li>Protocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for medium complexity 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. Work closely with internal statistical programmer.</li><li>Drug Development Strategy: Provides input to multiple aspects of the development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.</li><li>CRO / Vendor Oversight: Review CRO/vendor proposal and budget. Establishes procedures through regular interaction, setting expectation on deliverables and timelines to guide CRO biostatistician and statistical programmers on complex studies. Ensures deliverables are accurate and delivered according to the timelines.</li><li>Global Health Authority Interaction / Negotiation: Contributes to documents submitted to Health Authorities globally by providing input for the interaction or by writing the interaction document. May participate in meeting or teleconferences with Health Authorities</li><li>Global strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex biostatistical initiatives, with some level of supervision, to improve the harmonization and efficiency of drug development which leads to cost savings and shortened timelines for the company.</li></ul>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)<ul><li>PhD in statistics or biostatistics preferred</li><li>Master's Degree in Statistics/Biostatistics preferred</li></ul>Experience Qualifications<ul><li>4 or More Years relevant experience in the pharmaceutical industry with Ph.D preferred</li><li>4 or More Years with Masters 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, Evidence Generation Biostatistics

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 CMC Lead is responsible for supporting the overall CMC strategies within projects, and manage project teams. The project teams will be defined based on the project needs and the respective development stage of the project. The CMC Lead will support the Sr. CMC Lead on complex and/or late-stage project or act as main CMC Lead of an early-stage project. He/she has responsibility for the overall strategy and status of the project with respect to budget, timeline, achievement of defined milestones and overall project risk management. He/she will assess project issues and develop resolutions to meet smooth transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential critical issues, or to the governance bodies. Responsibilities - Accountability to lead teams within overall CMC development project(s), to support Sr CMC Lead. In case no Sr CMC Lead is established, take main responsibility for CMC lead. Provide operational coordination and management to drive strategies and activities for early and late phase drug development candidates within the team to support overall CMC development plan. - Represent CMC development project teams on cross-functional drug development project teams with a predominately operational focus; ensuring to establish good working relationships with internal and external stakeholders, e.g., Tech Unit, SMEs. Communicate closely with Sr. CMC Lead, other Tech Unit stake holders, and SMEs to build and execute an effective CMC development strategy. - Leads special project(s)/committee(s) that are critical to Compound development and/or Tech Unit milestones. Continuously seek opportunities for the improvement in daily work (incl. alternative approaches) and respectively propose/implement such actions. Participate in cross-functional teams responsible for regional and global process improvements in the operational efficiency of PJ Lead and Tech Unit. - Provides leadership in the project/development team, as Matrix Lead, interfacing with various site locations globally and on Alliance/co-development operational teams, other functions in Technology Unit, and key business partners. - Requires preparation and presentation of comprehensive internal and external presentations, and decision memo, encompassing all relevant areas of the relevant tasks 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 chemistry, biochemistry, pharamceutics or related disciplines within the pharmaceutical/biotechnology sciences with at least 7 years of industry experience required - Master's Degree Master's degree in chemistry, biochemistry, pharmaceutics oe related disciplines in the pharmaceutical/biotechnology sciences with at least 7 years of industry experience. preferred - PhD PhD in chemistry, biochemistry, pharmaceutics, or related disciplines within the pharmaceutical/biotechnology sciences with at least 5 years of industry experience preferred Experience Qualifications - 4 or More Years (Preferably) 4 + years of experience with at least 2 + years within CMC Development in the pharmaceutical/biopharmaceutical industry preferred - 4 or More Years Ability to prioritize and manage multiple activities and priorities simultaneously. preferred - 4 or More Years Extensive experience in project management, process, product, and/or analytical development activities and pharmaceutical/oncology project development preferred - 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission experiences for oncology area preferred TravelAbility to travel up to 30% Global and domestic travel. International collaboration and communication (face to face, electronic and tele/video conferencing) across all global time zones 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.

Associate Director, CMC Lead

Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary As a Manager, Generative AI, you will be responsible for conceptualizing, developing, implementing, and ensuring adoption for Generative AI solutions process, from data acquisition and pre-processing to training and deployment across various departments of Daiichi Sankyo. You will join a global team of talented AI engineers collaborating with cross-functional teams to deliver innovative solutions. The ideal candidate will have a strong background in generative AI, excellent leadership skills, and a passion for pushing the boundaries of AI technology. Responsibilities - Collaborate with cross-functional teams to gain a deep understanding of their Generative AI goals and aspirations) and leverage this knowledge to develop Generative AI solutions that align with their needs. Drive the research, development, and implementation of generative AI models and algorithms, ensuring they meet the highest standards of performance, scalability, and reliability. - Drive the organization's GenAI strategy forward as a member of the GenAI Center of Excellence (CoE). This includes establishing frameworks and best practices for managing Gen AI solutions. Support development and implementation of Gen AI security and governance policies to ensure that data is collected, managed, and used in a responsible and ethical manner. - Manage and allocate resources effectively, ensuring the team has the necessary tools, infrastructure, and support to deliver high-quality AI solutions. Provide mentorship and guidance to individuals and teams on the effective use of GenAI and other AI technologies, tools, and techniques to drive successful outcomes. This involves sharing best practices, providing coaching and feedback, and supporting the professional development of team members. Additionally, actively foster a culture of continuous learning and development, encouraging the exploration of novel approaches and technologies in the AI/ML field. - Oversee on-going support for GenAI and other AI solution environments. Monitor and evaluate the performance of generative AI models and algorithms, identifying areas for improvement and implementing necessary enhancements. - Continuously evaluate new GenAI research, trends, technologies, tools, and platforms and their applications in the pharmaceutical industry. Optimize and tune data infrastructure and systems for performance, reliability, and scalability. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education (from an accredited college or university) - Bachelor's Degree Bachelor's degree in fields such as Computer Science, Information Technology required - Master's Degree Master's degree in fields such as Computer Science, Information Technology preferred Experience Required 5 or More Years of AI/ML experience, with at least 2 years in AI/ML, 1 year in Gen AI/NLP development and implementation. Strong knowledge of AI/ML algorithms and techniques, NLP, LLM techniques with a proven history of delivering business value Experience with big data technologies (e.g., Hadoop, Spark) and cloud-based AI/ML services (Azure Open AI /AWS) preferred. Deep understanding of Python and/or R programming languages, as well as experience in leveraging these tools to analyze complex datasets, build predictive models, and generate insights preferred. Preferred 1 or more years of experience in a leadership role within Data Science in a Global Life Sciences organization Demonstrated experience in the pharmaceutical industry, specifically in the field of oncology, with a deep understanding of the drug discovery and development process, clinical trials, and regulatory requirements. Travel Ability to travel up to 5% Occasional travel for meetings and seminars. 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, Generative AI

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 This position supports the strategy for driving global Clinical Study Start-Up activities for PV Safety Operations. This position develops SAE Flow Plans and electronic data capture (EDC) Safety report outputs, reviews clinical study protocols and the Clinical Study Oversight Plan,day-to-day management of DS Safety Notification Letter (SNL) System and manages uploads to TMF activities. This position will interact with global study teams and represent PV operations in global interactions with CS Physicians and other study team members. This position will also engage within CSPV and with CROs to execute study start up processes. Responsibilities<ul><li>Global PV Operations Representation on Clinical Study Teams: Represents PV Operations at multidisciplinary study meetings providing guidance on safety operations, oversight of initiatives and trouble-shooting issues. Liaison for CS Physician and Data Management for study related safety reporting. Will also act as PV Operations SPOC for study teams to ensure consistency and compliance across clinical study safety reporting and activities.</li><li>Global Clinical Study Start-Up Documentation: Reviews all clinical study protocols to ensure consistency in safety requirements across studies related to a similar compound. Develops and maintains the study specific SAE Flow Plan and collaborates with on behalf of CSPV Operations any other study related documentation such as the DMP and day-to-day management of DS Safety Notification Letter (SNL) System.</li><li>Electronic Data Capture (EDC) Responsibility: In conjunction with Data Management, establish the EDC strategy at the project and/or study level. Proactively identifies and manages risks at the project and/or study level as it relates to data capture and reporting. Establishes EDC standards for reporting to ensure quality and compliance in safety reporting.</li><li>Procedure Development: Supports the process redesign activities to ensure compliance and consistency across clinical study start-up activities. Reviews and provides input to SOPs, SOIs, and process guides.</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 Science required</li></ul>Experience Qualifications<ul><li>4 or More Years drug safety experience with technical experience in Electronic Data Capture and Safety Reporting preferred</li><li>7 or More Years MS, RN, or PharmD preferred, or total pharmaceutical industry experience in one or more of the following areas: Drug Safety, Epidemiology, and Clinical Development 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 Study Start Up, CSPV

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 17,000 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 Responsible for DSI Tech Unit operational activities for developing collaboration site, internal process improvement, developing business process and system integration. Contribute and execution of DSI Tech Unit strategic plans to achieve business objectives enhance productivity and increase efficiency within the DSI Tech Unit function and support team building activities to enhance DSI Tech Unit Team culture. Service as a primary contact with Legal and Quality Assurance regarding records Retention and Training Coordination. Demonstration and successful execution of departmental operating processes associated with legal and financial requirements including handling internal audit. Work closely with IT regarding implementation and utilization of new software tools developed by the DS organization and/ or establishment of functional system. This role requires the individual to drive to the completion of process improvements initiated by Leadership. Works with a high level of independence/autonomy on problems with high tactical complexity while independently prioritizing and resolving matters of confidentiality. Coordinating a budget planning and review meeting with Finance Business Partner, Function Head and stakeholders. Partner with Finance Business Partner to tracking quarterly LE and annual financial targets and create variances report. Maintaining vendor contracts, contractor data, and critical database information. Responsibilities - Project Management - Plan and execute various projects within the organization ensuring they are completed on time and within budget. - Establishes and maintains internal policies and procedures for administrative activities. Implements work plans and initiatives. - Develop, maintain, and thrive continuous enhancement of the DSI Tech Unit Regional Function SharePoint site as well as business forms, documentation and other web forms. - Process Improvement - Drives process, efficiency, and productivity improvement efforts within the DSI Tech Unit. Collaborate with Stakeholders and teams to ensure seamless communication and coordination across the organization. - Collaborates with DSI Tech Members and other administrative units to identify areas for improvement in business processes and implement changes to enhance efficiency and effectiveness. - Research and analyze information or data for trends, and variances to ensure acceptable business practices, procedures and compliance have been followed. - Contract Management/ Finance Liaison/ Internal Audit Support - Partner with DSI Finance Business Partner to maintain and track DSI Tech Unit Internal actual against budget, understanding variances. Collaborate with leader to ensuring that financial goals are met, and resources are utilized effectively. - Accountable for managing DSI Tech Unit contracting, outsourcing, and procurement activities. - Contract Management for contracts requiring internal approval and/or external approval (CMO, requests over $100k) is required. A full understanding of how to initiate a contract, shepherd the contract through the review and approval process (legal and contract owner), generate the appropriate PO, track and manage the PO contract, and ensure there is no service disruption is required. - Strategic Planning - Under the guidance of the Manager develop and implement business operational strategies that align with the overall goals and objectives of the DSI Tec Unit Regional operations. 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 relevant area of study required - Master's Degree in Business Administration preferred Experience Qualifications - 4 or More Years 5+ years experience in business operations, finance, or other related area, preferably in a global pharmaceutical company required - Experience in a global pharmaceutical company preferred Licenses and Certifications - Project Management certification preferred Travel Ability to travel up to 10% Business and/or conferences 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.

Manager, Management & Operations, DSI Tech Unit

Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The position is a key change agent and innovator for R&D financial systems and data analytics. Identifies R&D Financial Planning & Analytics (FP&A) or business opportunities and manages projects to implement cutting edge technology solutions to address those needs. Applies in depth system and business process knowledge in support of initiatives and is the key business partner to IT and Finance. Expert regarding integration between EPM systems (such as SAC, Planful), SAP modules and interoperability with other systems within the Finance landscape. Responsible for understanding the P&L as well as mastering the technological environment utilized within the Finance area. This role will also provide R&D management with information, insights and recommendations to support optimal designs of financial solutions. Provides training to other R&D finance team members or business customers as needed. Provides project management expertise to run process improvement projects. This position requires strong technical, business, and analytical skills to manage data quality monitoring & measuring, root cause analysis, logical design, testing, reporting, requirement gathering and development/maintenance of applications. This role will perform various data analytics and perform periodic financial processes. In addition, this position will manage the overall R&D process automation tasks & associated applications. Responsibilities - Provide in-depth FPA knowledge to implement financial technology solutions within RD Finance - Manage projects that affect RD financial systems and processes - Perform system configuration related to finance applications (such as SAC, CFIN) as required and act as a single point of contact with RD stakeholders and external vendors. - Manage and assess upgrades, changes and enhancements and perform full life cycle regression testing. - Analyze, design, configure, test system changes and train RD finance teams - Design change management, communication, and training programs to support Finance initiatives - Identify viable targets and implement robotics process automation - Implement SAP process improvements for RD and act as a liaison with IT - Streamline RD processes, sunset systems - Key role in SACP/EPM enhancements and projects - Identify new features and capabilities to expand user base - Support RD financial data analytics associated applications - Design and perform data analytics to support diagnostics and decision making - Design and develop new reports and/or queries in the production reporting environments - Assist in managing the global RD Financial Planning Analytics including the forecast and management of the global budget. - Implement data analytics systems for consolidating Global RD financial planning and actuals - Work with corporate finance to improve the quality and standards of reported financial data - Ensure user role maintenance and license management is provided for noted applications and system interoperability is coordinated (i.e. single sign-on configurations, etc.) - Perform and/or support RD changes such as: perform table updates, configure approval workflows, update artificial intelligence risk rules, and continually monitor and tweak the rules as needed - Provide end user support for RD finance specific applications - Process any Zendesk or Service Now support tickets that are assigned to RD Finance - RD Financial Process Automation Finance Controls - Cross trained in SAP and EPM master data requirements and able to support master data initiatives as needed - Responsible for the overall look and feel of the RD Finance teams' Fiori EPM applications home pages - Ensures RD Finance Intranet content is up to date - Recommends ways to use the site as a tool to increase awareness and/or user adoption of financial solutions - Participate and support the RD digital upskilling initiative - Provide training and maintain various training support documentation on company portal and teams/Sharepoint sites Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) - Bachelor's Degree Business Administration, Engineering, Finance or Accounting required Experience Qualifications - 4 or More Years Minimum of 5 years of increasing responsibility in FP&A, Corporate Finance and/or Financial Reporting Systems required and - 4 or More Years Experience with SAP in FI or EPM Applications and practices, database elements, relationship and query concepts/report writing skills required and - 4 or More Years Strong technical knowledge and analytical skills required and - Prior project management experience preferred and - Pharmaceutical industry experience 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.

Manager, R&D Financial Systems & Integrated 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 Position manages end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and other vendors to ensure high quality deliverables are on time and within budget 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 has a working knowledge of Electronic Data Capture/related applications and industry standards, and moderate technical skills in working with data received from CROs and other third party vendors. This position has 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 possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience working on Phase I-IV studies within the medical device and/or pharmaceutical industry within one or more therapeutic areas. Finally, this position has moderate skills in continuous improvement, project management, change management, and risk management. Responsibilities<ul><li>Leadership, Direction, and Strategy:<ul><li>Establishes Data Management strategy at the project and/or study level for a smaller number of projects/studies Proactively identifies and manages risks at the project and/or study level for a smaller number of projects/studies</li></ul></li></ul><ul><li>Project Management:<ul><li>Plans and directs the conduct of Data Management activities for assigned projects/studies through outsourcing (e.g., study startup, study conduct, study closeout, and reporting).</li><li>Provides oversight for Data Management CRO and other third party vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines.</li><li>Ensures Data Management deliverables meet/exceed project/study team expectations regarding quality, time, and cost and that Data Management documentation is filed/archived according to applicable Daiichi Sankyo and regulatory requirements.</li></ul></li></ul><ul><li>Functional Expertise:<ul><li>Reviews/approves clinical study related documents (e.g., Protocols, Data Management Plan, Clinical Study Reports).</li><li>Leads and drives the data review process in collaboration with the study team to ensure data quality</li><li>Participates in audits and inspections.</li></ul></li></ul><ul><li>Operational Efficiency / Continuous Improvement:<ul><li>Provides comprehensive data management expertise to project/study teams to optimize study-specific clinical trial processes.</li><li>May participate in process improvement initiatives.</li></ul></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 related field required</li><li>Master's Degree in life sciences or related field preferred</li><li>RN in life sciences or related field will be considered.</li></ul>Experience Qualifications<ul><li>4 or more years data management and/or related industry work experience in a medical device, pharmaceutical company, or similar environment (e.g., CRO) 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, Data 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. Summary Position leads statistical support for medium complexity studies including contributing to development of optimal study design, independently develop and execute statistical analysis plan and helps in 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 works on statistical methodology and leads/contributes to internal statistical workstreams to address various project needs. The position works closely with contract research organization (CRO) programmers and statisticians and collaborates with internal programmers in preparing analysis files and performing statistical analyses. Additionally, this position interacts with study teams, as well as statisticians and programmers at CROs. This position works under some supervision to solve complex study problems. Responsibilities<ul><li>Protocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for medium complexity 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. Work closely with internal statistical programmer.</li><li>Drug Development Strategy: Provides input to multiple aspects of the development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.</li><li>CRO / Vendor Oversight: Review CRO/vendor proposal and budget. Establishes procedures through regular interaction, setting expectation on deliverables and timelines to guide CRO biostatistician and statistical programmers on complex studies. Ensures deliverables are accurate and delivered according to the timelines.</li><li>Global Health Authority Interaction / Negotiation: Contributes to documents submitted to Health Authorities globally by providing input for the interaction or by writing the interaction document. May participate in meeting or teleconferences with Health Authorities</li><li>Global strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex biostatistical initiatives, with some level of supervision, to improve the harmonization and efficiency of drug development which leads to cost savings and shortened timelines for the company.</li></ul>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)<ul><li>PhD in statistics or biostatistics preferred</li><li>Master's Degree in Statistics/Biostatistics preferred</li></ul>Experience Qualifications<ul><li>3 or More Years relevant experience in the pharmaceutical industry with Ph.D preferred</li><li>5 or More Years with Masters 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, Biostatistics

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 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary This position is responsible to support strategic leadership of QA initiatives within QA and will have the primary responsibility to collaborate with, and support the head of Global QA strategy and operations. In this position, the incumbent will take on organizational responsibilities relevant to drafting global communications for QA, QA projects as assigned, ensuring onboarding of N-3 leaders directly reporting to the VP of Quality, and in close collaboration with the QA Training and Documentation management team. This position will take direction from global strategy and operational QA leader, however is also accountable to the VP of quality. The incumbent is expected to understand and apply rigor, focus and dedication with respect to the complexity of the Global organization. This position has considerable latitude to make decisions without supervisor approval and solves problems while carrying out assigned duties. Additionally, this position is responsible for upholding a strong commitment to confidentiality and routinely handles sensitive documents that may impact multiple Global organizational units or Global project teams. The incumbent may be tasked under the direction of the Global Strategy and Operations Head, to draft presentation for VP of QA, assess organizational transformation and its effectiveness and support large conferences and meetings. The incumbent must have excellent communication, oral and written skills. The incumbent must have understanding of state of the art technology systems necessary to complete tasks and allow decision making. Responsibilities - Support Head, Global strategy and operations on projects needing to be coordinated with both DSI QA and Global QA, ensure that teams are adequately engaged to deliver as expected and escalate any delays to Head of Group and / or Head Global strategy and operations. - Supports Head Global Strategy and Operations for Global RD/PV/MA QA relevant activities including QQR, monthly quality report, team building and management review. - Involve and attend the Global QA relevant meeting and create the draft of presentation, meeting agenda and meeting minutes. - Involve and attend the Global RD/PV/MA QA strategic meeting and create the draft of presentation, meeting agenda and meeting minutes. - May be delegated for logistic planning and coordinating the QA Meeting which including the QA leadership meeting, Global QA meeting etc. - Support Head, Global Strategy and Operations to track the objective and the mid-term plan in Global QA to ensure Global QA activities globally. - Support Head, Global Strategy and Operations to draft the Global RD/PV/MA QA strategy operation plan with Head, Global QA function to ensure Global QA activities globally. Support Operational activities: - Manage the QA shared point and ensure that information provided is accurate and reflects on going activities. Regularly check the site for accuracy, up to date information, and links as well as compile new content as required. Send periodic alerts to teams to ensure that shared point data is current and accurate - In collaboration with Head, Global QA Strategy and Operations, Collate and produce accurate and timely reports as needed pertaining to Global QA activities - In collaboration with Executive admin, ensure QA org charts, team lists, projects assigned to individuals are current and up to date - Support regulatory inspection related activities as required - Support Head, Global strategy and operations to develop and plan the Global QA governance, communication strategies and manage the communication activities; - Distribute reports as necessary to the Global QA teams and ensure on time organization communication is cascaded to the teams for awareness. - Creates and proofs packets of information; develops documents and materials for meetings and a wide array of audiences - Edits and produces advanced internal and external communications; acts on behalf of an executive for certain decisions or activities (e.g., e-mails) - Create the weekly QA communication e-mail - Administrative support includes but not limited to: Responsible for travel, Financial Administration as needed (e.g. tracking of expenses for travel and office space), meeting arrangements for Head of Group and other associates as applicable. Handling of confidential documents (reorganization, talent profile, Financial Budget) - Manage Calendar for DSI QA Head and Head, Global Strategy and Operations and ensure an organized approach - Onboarding support: Coordinate QA on boarding business training with New Hire and ensure New Hire has a sufficient access to the system and information to do that work. - Review the QA onboarding business slides edits and updates as needed 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 scientific discipline or higher in, health care, or related discipline; and/or background in Medical Health Profession required Higher level of education preferred such as: - Master's Degree in scientific discipline or higher in, health care, or related discipline; and/or background in Medical Health Profession preferred - PharmD in scientific discipline or higher in, health care, or related discipline; and/or background in Medical Health Profession preferred - PhD in scientific discipline or higher in, health care, or related discipline; and/or background in Medical Health Profession preferred Experience Qualifications - 7+ years of professional pharmaceutical experience in project management and operational support role and relevant additional career training or equivalent experience required - Must have broad understanding of Health Authority expectations in the areas of Pharma Development; preferably working in a GxP regulated environment, pharmaceutical industry. - Proven knowledge of training and curricula development experience desirable, including oversight and administration of validated electronic systems such as LMS or other quality management systems. - Must possess strong interpersonal, communication, negotiation and problem-solving skills. - Organizational awareness (e.g. inter-relationships of departments, business priorities), including experience working cross-functionally, Cross cultural and in global teams - In depth knowledge and working experience with common computer software programs, i.e. MS Office Suite (Word, Excel, Access, Outlook, PowerPoint, Visio, MS Project) Physical Requirements: Shipping out large packages/boxes. Moving/arranging file folders in large quantities. 5% of Time Travel 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.

Associate Director, Global Strategy and Operations (Global R&D PV QA)

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 Provide strategic leadership for all statistical programming activity related to study, project and submission. Manage CRO to ensure high quality compound and multi-compound level deliverables. Lead the development of global harmonization of programming processes supporting global submission. Responsibilities - Statistical Programming Management: Coordinates outsourced statistical programming of analysis data sets and tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this work. Possesses in-depth knowledge of regulatory authority's requirements. Typically has administrative responsibility for recruiting, retaining, developing, and managing employees. Guide career growth and provide development opportunity for statistical programmers. Manages contract statistical programming staff to ensure proper resource allocation for achieving successful project deliverables. Provides oversight of all statistical programming activities performed by contractors in different oncology trials as well as submission-related activities, e.g., integrated summary of safety (ISS) and integrated summary of efficacy (ISE). - Direct Project Support: Providing direct support to key studies in order to ensure sufficient planning of statistical deliverables from vendors as well as work by in-house statistical programmers. - CRO / Vendor Oversight: Manages higher-level negotiations and provides oversight of budget, resources, and timelines for contract research organizations (CROs) for multiple projects and ensures timely delivery of high quality deliverables at reasonable cost. Identify/develop tools for efficient vendor management. - Global Health Authority Interaction / Negotiation: Reviews documents and responses submitted to health authorities globally with respect to data standards, compliance, etc. May represents the function at health authority meetings. Reviews and provides input to TLF shells for submission documents (e.g., ISE and ISS). Develops the process for ensuring that analysis data sets and outputs are compliant with regulatory requirements, including CDISC ADaM data set specifications, reviewer's guides, etc. - Global Biostatistics Data Management (BDM) Strategy to Improve Drug Development: Leads implementation of vision and strategy, and identifies technology needs for the function to improve the harmonization and efficiency which leads to cost savings and accelerated worldwide product submissions and approvals. Authors or initiates writing of global standard operating procedures for statistical programming practice, especially with respect to oversight of vendor performance. Oversees compliance with standard procedures and processes. Leads the development and refinement of analysis data standards for AML as well as solid tumor studies. - Leadership of Strategic Initiative and Cross-Functional Collaboration: Provide leadership for strategic and process improvement initiatives within Biostatistics Data Management. Works with colleagues at DST and DSE to identify opportunities for global harmonization and process improvement. Ensure close collaboration with other functional areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs, etc. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) - Bachelor's Degree an accredited institution in a science or in a technical field preferred - Master's Degree preferred Experience Qualifications - 10 or More Years experience (Bachelor 12 or More Years) in pharmaceutical industry preferred - Thorough understanding and proficiency of CDISC. preferred - Advanced knowledge of CDISC requirements for SDTM and ADaM. preferred - Worked and played major role in electronic NDA and/or BLA submission via eCTD preferred - Working knowledge in statistics as measured by ability to interpret SAPs/shells to generate ADaM and TLFs. preferred - Strong project management experience and ability to manage and execute multiple projects and deadlines preferred Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Director, Statistical Programming

Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary This position will be responsible for managing and overseeing the execution of key Global and/or National congress activities and ensure alignment with overall strategic business objectives of strengthening Daiichi Sanyo as a leader in Oncology and increasing awareness of its portfolio and products. Partner with key stakeholders, cross functional and regional teams, agencies and healthcare associations to develop and implement congress operational programs, budgets and tactics for the successful and compliant execution of all congresses. Responsibilities - Congress Planning and Execution Management - Manage the planning and onsite execution for the global and national congresses. - Partner with key stakeholder and congress leads to influence decision related to pipeline, disease awareness and commercial brands execution at oncology congresses - Develop congress plans that best support their objectives-based audience and targets - Anticipate and execute congress booth plans for complex scenarios based on potential launches - Provide historical data analytics to support and justify presence at congresses. Develop and recommend list of congresses that would best support the company and brand objectives. - Lead planning and execution weekly meetings with Global and/or National Congresses key stakeholders. Identify, assess and communicate potential obstacles that could adversely affect the successful execution of congresses. - Leverage emerging technology and industry trends when designing and creating exhibit booth elements with a focus on prioritizing business objectives and increasing corporate awareness. - Drive collaboration and partnerships between DS Regional Congress lead (DSE, DBR...) to align on expectations, ensure global participation and exhibit execution are incompliance with local country laws and regulations as differ from country to country - Leading special projects that have an impact on the program and organization - Budget Management - Fiscally responsible for establishing, monitoring and managing multimillion congress budgets - Manage complex quarterly LE for congress spend and multiple allocations with all global and brand congress leads - Manage the congress monthly pre-pay accounts and reconciliations to appropriate cost centers and Work Breakdown Structure (WBS). - Responsible for anticipating and managing risk to ensure all parts of the project are clearly defined, communicated and nothing is overlooked with congress leads - Establish forecast analysis for congress booth, booth logistics, expo suite and expo suites logistics and attendee management (housing, registration, and air travel). - Relationship Management - Manage and oversee the coordination of congress vendors that support the execution of congress activities. - Foster strong, collaborative relationships with vendors. Ensuring that the terms and deadlines are met. Evaluating vendor performance, assessing spend, maximize value from vendors, ensure service quality. Reduce costs without compromising quality. Monitor projects and seek efficiency. Mitigate potential risks, including any third-party disruptions. - Evaluate current vendor processes and systems for continue to enhance programs. - Legal and Compliance Management - Manage and oversee complex processes for approval of material within the exhibit booth and accountable for final exhibit booth approval - Ensure co-promote rules and regulations are adhered - Liaise between country legal and - Manage the Compliance training for reps staffing including reviewing the training material annually and updating when necessary. - Responsible for annual AOP review and updates. 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 Marketing or Communications or commensurate experience required Experience Qualifications - 4 or More Years 5+ years of pharmaceutical industry and Congress experience required - Understanding on Pharma guidelines and Federal/State regulations preferred Travel Ability to travel up to 20%. Travel, mostly weekends, on-site to provide marketing support, conduct walk-thru with brand leads and agencies, pre-show rep training at the booth, vendor management and report on exhibit trends, competitors show floor activities/booth. 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, Congress Operations

Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary 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: - Providing input into the Request for Proposal (RFP) process and protocol development process for assigned clinical trials; - 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; - Supporting transparency in operational planning through tracking IRT-related milestones and dashboard inputs; and - Ensuring inspection readiness of IRT-related items for assigned clinical trials. - Conduct oversight of assigned IRT vendors, ensuring timelines and data quality standards are met. - Lead and/or contribute to cross-functional and global improvement projects including IRT-related data and/or IRT vendors. - Support compliance audits, IRT vendor audits and regulatory inspections. 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 Science or related field. Extensive relevant experience (+15 years in the industry) will be considered in lieu of a Bachelor's Degree required - Master's Degree in Science or related field preferred Experience Qualifications - Minimum 8 years of 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 - Minimum of 4 years direct experience leading IRT-related projects with cross-functional stakeholders preferred - Experience leading IRT-related projects across global teams preferred - Oncology experience is preferred Travel Ability to travel up to 20% Single day/Overnight/ multi-day travel will be required to go to outsourced vendors or company offices. 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, 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. 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, Regulatory Affairs - Regulatory Project Management (RPM) provides planning and coordination supports for global and US regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) and global regulatory team (GRT) for assigned projects and activities to achieve regulatory milestones and deliverables successfully and in a timely manner. The manager, RPM contributes to the RPM group by sharing best practice and escalating process and operational issues in a timely manner and continuous RPM process improvement with focus on quality, reliability, consistency and efficiency. Responsibilities<ul><li>Plan, coordinate, and review US regulatory submissions in collaboration with USRL, Regulatory Operations (RO), and other key stakeholders (e.g. Protocol Amendments, Form 1572s, Information Amendments, Meeting Requests/Background Materials, DSUR, IND/NDA/BLA annual reports, BTD request etc.).</li><li>Develop less complex Module 1 regulatory documents (e.g. cover letter, FDA forms, administrative information, letter of authorization, etc.) for US regulatory submissions.</li><li>Support FDA meeting preparation including preparation of briefing document, meeting request, response to FDA preliminary comments and logistics.</li><li>Support FDA meeting preparation including preparation of briefing document, meeting request, response to FDA preliminary comments and logistics.</li><li>Support GRL with scheduling regulatory meetings, preparing agenda and tracking action items</li><li>Responsible for maintaining global health authority query (HAQ) tracker and archiving regulatory correspondences.</li><li>Support DSUR/PBRER preparation by attending Kick-off Meeting, coordinating and assisting in developing regulatory sections.</li><li>Schedule RRT meeting, creates response templates and coordinates processes for authoring and review of response as appropriate.</li><li>Provide support or coordinate other regulatory activities per direction from GRL and regulatory strategists.</li><li>Share RPM best practices and contributed to RPM process improvement</li><li>Keep current with regulatory and scientific regulations, guidelines and initiatives</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 Preferably in a scientific discipline required</li><li>Advanced degree (e.g., Masters, Pharm.D., Ph.D.) preferred</li></ul>Experience Qualifications<ul><li>4 or More Years Relevant pharmaceutical experience (education and/or industry)</li><li>1 or More Years Industry experience (within regulatory is preferred)</li></ul>Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Manager, Regulatory Affairs - RPM

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 purpose of this job is to provide statistical/data science programming as well as technical support for Daiichi Sankyo's RWE projects to improve Daiichi Sankyo programming and computing efficiency by evaluating tools and software in the use of real-world data (RWD). Responsibilities - Provide programming support for RWE project or study to deliver the TLFs on time and support ad-hoc requests. - Develop and maintain necessary programming macros or tools to effectively support all programming needs. Responsibilities include: identify the macros or tools that will facilitate programing efficiency, support the macro or tool development, and support the macro or tool implementation and maintenance. - Evaluate, assess and enhance DSI computing environment system with some supervision. Responsibilities include: assess DSI new computing environment system for programming and analysis efficiency, identify system bug/issue and lead the activity to enhance the system, develop system training materials and work as the SME to support implementation, evaluate, request and approve system upgrades, and propose/develop system utilities. - Provide input to build a strong RWD environment, RWE computing environment, promote innovative solutions, operational excellence and develop efficient processes and standards for RWE. - Demonstrate high level proficiency for Machine Learning (ML) and Artificial Intelligence (AI) technology, align with future roadmap, network with other business area/analytics group to promote efficiency in the use of AI/ML. 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 from an accredited institution in science or in a technical field required. - Master's Degree preferred Experience Qualifications - 7 or More Years Minimum 7 years (or Master's degree with minimum of 4 years) proven experience within pharmaceutical industry, or CROs supporting statistical programming preferred - 4 or More Years Previous experience supporting macro and/or system utility development is highly preferred preferred - Advanced working knowledge of statistical or script programming language such as SAS, R, Python, SQL preferred - Understanding of statistical concepts in support of analyses preferred - Experience in using the RWD including retrospective database, registries, EMR and claims preferred - Knowledge in the secondary database structures or external control arms preferred - Experience in statistical modelling (time to event analysis), causal inference methods (Mixed Models for Repeated Measures, Cox proportional hazard model, propensity scoring techniques, comparative effectiveness analysis, etc.) is 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.

Manager, RWE Programming - Real World Evidence

Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to the effective strategy, design, execution, and interpretation of Oncology clinical trials. Position Summary / Objective: Serves as a primary source of medical accountability and oversight for one or more clinical trials. Matrix management responsibilities across the internal and external network. Manages Phase 1 - Phase 3 studies (depending on assignment) with demonstrated decision-making capabilities. Provides medical and scientific expertise to cross-functional DSI colleagues Responsibilities Medical Monitoring: <ul><li>For studies in which Medical Monitoring activities are conducted in-house:</li><li>Provides medical input regarding country feasibility. Consulted on decisions related to clinical trial feasibility and contributes to the site feasibility assessment from a physician's perspective</li><li>May provide clinical input into the eCRF (Case Report Form) design, participate in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) review</li><li>Conducts clinical data review per Integrated Data Review Plan</li><li>Accountable for the assessment of protocol deviations</li><li>Discusses medical eligibility questions and answers safety questions (dose modifications, discontinuations, and management of adverse events)</li><li>May participate in Site Initiation Visit (SIV) and conduct medical monitoring visits at any time during the conduct of the study to provide medical input</li><li>Provides medical guidance for coding of AEs, medical history, and medications when needed</li><li>Addresses medical questions directly from sites/ Institutional Review Boards (IRBs), and other site personnel as needed</li><li>Study-specific subject matter expert (ME) for internal audit or Health Authority (HA) questions related to medical monitoring</li><li>For studies in which Medical Monitoring activities are conducted by the Contract Research Organization (CRO) Medical Monitor (MM):</li><li>Provides oversight to the CRO MM for clinical data review activities</li><li>May support addressing eligibility and medical questions from sites/ IRBs</li><li>May provide medical guidance for coding of AEs, medical history, and medications when needed</li></ul> Clinical Development Expertise Strategy: <ul><li>In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of the Clinical Development Plan (CDP). Ensures individual protocols are consistent with CDP and aligned to achieve the Target Product Profile (TPP)</li><li>Development of clinical sections of trial-level regulatory documents (e.g., response to HAs, briefing book, etc.) in conjunction with Medical Writing</li><li>Leads scientific components of IM (Investigators Meeting) and SIV (Site Initiation Visit) Training: compound, Diagnosis (Dx) Overview, in collaboration with Clinical Scientists (CS)</li><li>Interpretation and presentation of clinical study(ies) data to internal and external stakeholders</li><li>Provides medical/scientific training on compound/disease and dose modifications/discontinuations as well as management of adverse events based upon approved Safety Management Team (SMT) materials</li><li>Supports overall program safety reporting (e.g., Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety-related documents, in collaboration with the Safety Physician</li><li>Maintain up-to-date knowledge of all-important advances within a disease area through scientific literature, critical meetings, and relationships with Key External Experts (KEEs). Contributes to clinical/scientific training of relevant DSI stakeholders on the disease area, competitive landscape, and compound/drug. May serve as speaker for program/ franchise medical/scientific training in collaboration with the GCL, if applicable</li><li>Delivers all relevant components needed for maintenance of product licenses (e.g., Core Data Sheet generation/revision; clinical benefit-risk assessments for license renewals, responses to Health Authority)</li><li>Participant and voting member in the labeling development process in the Labeling Working Team (LWT), in collaboration with the CDL</li><li>Contributes from a medical strategy standpoint to developing the Clinical Study Report (CSR). May review tables, listings, and figures (TLF) and CSR safety narratives</li><li>May lead the development and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of the other sections in collaboration with the other authoring functions</li><li>Accountable for Protocol content/study design development</li><li>Contributes from a medical strategy standpoint to the development of clinical sections of study-level documents (e.g., protocol, amendments)</li><li>Reviews safety data to mitigate risk to trial participants for the assigned trial per protocol</li><li>Development of charters for the Steering Committee (SC), Endpoint Committee, and Data Monitoring Committee (DMC). Identify committee members and coordinate/facilitate meetings</li><li>Primary contact for DMC, Endpoint Committee, and SC: Reviews; Presents study updates to the DMC in the open session</li><li>Reports on/prepares presentation material of trial safety information/data to internal and external safety boards (e.g., DMC, SC, Ad boards).</li><li>PP and EPP (Expected Product Profile) development in collaboration with peer functions and CS</li><li>Oversight of Academic Research Organization (ARO) or Cooperative Group partnership, if applicable</li><li>Health Authority Interactions Publications</li><li>May contribute to addressing questions about medical decisions, clinical data review, protocol deviations, etc., and/or scientific aspects of the study during FDA, MHRA, EMA, and PMDA interactions, such as pre-submissions, end of phase 1/2, and inspections</li><li>May support the GCL, if applicable, in planning and executing the overall publication and clinical communication strategy (overall or at the individual trial level), providing input to key external presentations.</li><li>Contributes to and serves as the medical point of expertise in key Health Authority interactions and Ad board meetings</li></ul>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications: (from an accredited college or university)<ul><li>MD required</li><li>Postgraduate training in TA or related specialty required Experience</li></ul>Qualifications:<ul><li>7 or More Years relevant clinical experience required</li><li>Travel - Ability to travel up to 20% Domestic and International travel will be required.</li></ul> Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Senior Director, Oncology R&D

Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of Global Medical Affairs' externally sponsored clinical research (ESR) initiatives, ensuring strict adherence to Good Clinical Practices (GCPs), relevant Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations, EU Directives, and International Conference on Harmonization (ICH) guidelines. This role emphasizes the management of Investigator Initiated Studies (IIS) and Collaborative External Sponsored Research (CESR) projects. Candidates should have a comprehensive understanding of clinical trial management, with firsthand experience managing collaborative research studies being highly desirable. Responsibilities:<ul><li>Lifecycle Management: Oversee and manage the complete lifecycle of externally sponsored research, including both IIS and collaborative studies. Ensure projects align with strategic goals and compliance standards from initiation through completion.</li><li>Operational Strategy: Develop and implement ESR team operational strategies for externally sponsored studies. Serve as the global ESR lead for assigned assets to ensure optimal execution and outcomes, addressing potential issues proactively and ensuring adherence to timelines.</li><li>Program Leadership: Lead and manage multiple research programs, demonstrating expertise in both strategy formulation and operational execution in the field of externally sponsored research. Provide clear direction and guidance to project teams.</li><li>Committee Facilitation: Facilitate review committee meetings, ensuring comprehensive documentation of meeting outcomes, decisions, and action items. Coordinate with stakeholders to ensure timely follow-up and resolution of issues.</li><li>Clinical Trial Management: Oversee clinical trial functions including CTA negotiations, Fair Market Value evaluations, milestone follow-ups, study enrollment updates, study reports, and closeout procedures. Work closely with study site operational staff to ensure timely and accurate updates.</li><li>Project Management: Demonstrate advanced project management skills, facilitating discussions with internal and external cross-functional teams. Present findings and project statuses to cross-functional leadership and alliance management teams.</li><li>Budget Management: Exhibit strong budget management experience, including forecasting, reforecasting, and managing plan vs. actuals. Preferably, have experience managing global studies involving multiple currencies and complex financial tracking.</li><li>Vendor and Site Management: Direct and enhance interactions with investigator sites and other external vendors to ensure projects are delivered on time, within budget, and meet high-quality standards. Ensure effective communication and issue resolution.</li><li>Communication and Collaboration: Foster and maintain effective communication channels within a global, multi-disciplinary team environment. Ensure alignment and collaboration across functions, regional ESR and Medical teams as well as alliance partners, promoting a cohesive team approach.</li><li>Regulatory and Safety Compliance: Understand study conduct from supply chain/drug forecasting to safety and regulatory requirements related to studies using investigational drugs and commercial products. Demonstrate experience in various types of studies across all phases, with a preference for oncology.</li></ul> People Management: This position may require the supervision of functional and/or direct reports by providing instruction and direction of daily activities in support of goals. Assume potential line management responsibilities for ESR Managers focused on the tactical aspects of study execution. In their absence, take on both strategic and tactical responsibilities to ensure study continuity and success. 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 the Life Sciences required</li><li>Master's Degree Life Sciences preferred</li></ul>Experience Qualifications<ul><li>4 or More Years relevant working experience in externally sponsored research, including IIS and collaborative studies required</li><li>4 or More Years in a clinical management setting required</li><li>A robust background in navigating complex regulatory environments and achieving study objectives efficiently and effectively required</li><li>Strong understanding of Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), FDA regulations, EU Directives, and ICH guidelines required</li><li>Excellent communication, organizational, and problem-solving skills required</li><li>Proven people management experience, demonstrating effective leadership and team development preferred</li><li>Ability to travel up to 10% In-house office position that may require travel (global).</li></ul> Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.