Senior Director, Clinical Development

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