Senior Director, Clinical Development

Job Summary

Responsibilities

• Medical Monitoring
• Provides medical input on study and country feasibility, including site feasibility assessments
• Contributes to eCRF design, UAT, and CRF Completion Guidelines as needed
• Conducts ongoing clinical data review and assesses protocol deviations
• Addresses medical queries from sites/IRBs, including eligibility, safety, dose modifications, and adverse event management
• Serves as study medical expert and oversees CRO Medical Monitor activities, including data review and medical guidance (e.g., AE coding)
• Clinical Development Expertise & Strategy
• Leads 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 management
• Maintains 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 oversight
• Oversees external partnerships (e.g., CROs, AROs, cooperative groups) and contributes to labeling and product lifecycle management
• Health Authority Interactions & Publications
• 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
• 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.
• Contributes to and serves as the medical point of expertise in key Health Authority interactions and Ad board meetings

Qualifications

• Education Qualifications
• MD required
• Postgraduate training in TA or related specialty required
• Experience Qualifications
• 7+ years of relevant clinical experience required
• Travel Requirements Ability 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$467,250.00
• Download Our Benefits Summary PDF