Senior Director, Clinical Development (Basking Ridge)

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to be an innovative global healthcare company contributing to the sustainable development of society, we are shaping a healthier, more hopeful future for patients, their families, and society.Job SummaryThe 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 / ObjectiveServes as a primary source of medical accountability and oversight for one or more clinical trialsMatrix management responsibilities across the internal and external networkManages Phase 1 - Phase 3 studies (depending on assignment) with demonstrated decision-making capabilitiesProvides medical and scientific expertise to cross-functional DSI colleaguesJob DescriptionResponsibilitiesMedical Monitoring Provides medical input on study and country feasibility, including site feasibility assessmentsContributes to eCRF design, UAT, and CRF Completion Guidelines as neededConducts ongoing clinical data review and assesses protocol deviationsAddresses medical queries from sites/IRBs, including eligibility, safety, dose modifications, and adverse event managementServes as study medical expert and oversees CRO Medical Monitor activities, including data review and medical guidance (e.g., AE coding)Responsibilities ContinuedClinical Development Expertise & StrategyLeads development and execution of the Clinical Development Plan (CDP), ensuring alignment with protocols and Target Product Profile (TPP)Provides medical/scientific leadership for study design, protocol development, and key study-level documents (e.g., CSR, IB, regulatory responses)Interprets and presents clinical data to internal and external stakeholders; supports regulatory and safety reporting (e.g., DSUR, PSUR)Delivers scientific training and leads key study meetings (e.g., IM, SIV) on compound, disease, and safety managementMaintains deep therapeutic area expertise and contributes to strategic insights on disease landscape, competition, and product positioning (TPP/EPP)Leads engagement with governance bodies (e.g., DMC, Steering Committee), including charter development, presentations, and ongoing oversightOversees external partnerships (e.g., CROs, AROs, cooperative groups) and contributes to labeling and product lifecycle managementHealth Authority Interactions & PublicationsMay 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 inspectionsMay 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.Contributes to and serves as the medical point of expertise in key Health Authority interactions and Ad board meetingsQualificationsEducation QualificationsMD requiredPostgraduate training in TA or related specialty requiredExperience Qualifications7 or more years relevant clinical experience requiredTravel RequirementsAbility to travel up to 20% of the time. Domestic and International travel will be 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.Salary Range:USD$280,350.00 - USD$467,250.00Download Our Benefits Summary PDF