Senior Director, Clinical Development

Merck & Co.; Basking Ridge (NJ); On-site; USD 280,350 - 467,250; Full time

Job summary

Daiichi Sankyo, Inc. seeks a Senior Director within Global Oncology Clinical Development to oversee medical accountability for trials and provide scientific leadership across study design, data interpretation, and regulatory engagement.

This role requires MD with postgraduate training and 7+ years of clinical experience, with up to 20% travel. Based in the United States, New Jersey region.

Qualifications

• MD required.
• Postgraduate training in therapeutic area or related specialty required.
• 7+ years relevant clinical experience.

Responsibilities

• Provides medical accountability and oversight for one or more clinical trials.
• Oversees CRO medical monitor activities and data review.
• Leads development and execution of the Clinical Development Plan (CDP).
• Interacts with health authorities and prepares regulatory responses.

Skills

Medical Oversight

Clinical Development

Regulatory Interactions

Data Review

Education

MD

Postgraduate training in therapeutic area or related specialty

Job description

Job Summary

The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to the effective strategy, design, execution, and interpretation of oncology clinical trials.

Position Summary / Objective

• 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

• 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 therapeutic area or related specialty required

Experience Qualifications

• 7 or more years relevant clinical experience required

Travel Requirements

Ability to travel up to 20% of the time. Domestic and international travel will be required.

Equal Opportunity Statement

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