Senior Director, Clinical Development

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

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