Director Clinical Development

Role: Lead clinical scientific oversight of global Phase 2 and 3 trials within late-stage development, supporting NDA/BLA submissions. Responsibilities: design and supervise pivotal trials ensuring alignment with target product profile, collaborate with cross-functional teams (Regulatory, Biostatistics, Clinical Ops), develop and review study materials, and prepare for regulatory interactions. Contribute to clinical data analysis, reporting, and scientific publications. Requirements: PhD, PharmD, or equivalent; 8-10 years experience in clinical development, with proven success managing Phase 3 studies; strong expertise in trial design, GCP, ICH guidelines, and regulatory processes. HighValue: late-stage trials, global scope, NDA/BLA readiness, immunology/inflammation therapeutic area experience preferred, with focus on biologics or advanced modalities. WorkSetup: not specified, but implies global/regional coordination in regulated environment.