Director, Safety Sciences

Role: Lead safety strategy and evaluation for clinical-stage oncology programs, focusing on regulatory submissions and benefit-risk assessments. Responsibilities: develop safety deliverables for NDA/BLA filings, author and review integrated safety documents, collaborate on safety analyses, and ensure compliance with global pharmacovigilance regulations; support regulatory meetings and contribute to labeling strategies; oversee safety reporting activities. Requirements: MD, PhD, PharmD, or RN with 8+ (MD, PhD, PharmD) or 10+ (RN) years' pharmacovigilance experience in biopharma; expertise in late-phase clinical development, NDA/BLA submission readiness, safety data integration, and benefit-risk justification; strong knowledge of clinical safety databases, regulatory guidelines, and risk management. HighValue: small molecule oncology, Phase 3, NDA/BLA, global regulatory compliance, safety data analysis, benefit-risk assessment, regulatory agency interactions. WorkSetup: based in San Francisco or Boston with less than 10% travel.