Director, Safety Sciences

Role: Director, Safety Sciences — leading clinical safety data strategy and communication throughout drug development, supporting regulatory submissions, and ensuring global compliance. Responsibilities: oversee safety deliverables for NDA/BLA filings, author and review safety documents (e.g., ISS, benefit-risk assessments), and coordinate safety strategies with cross-functional teams including Regulatory Affairs, Medical, and Biostatistics. Support safety data integration, manage safety narratives, datasets, safety labeling, and risk management plans, and participate in regulatory agency meetings. Requirements: MD, PhD, PharmD, or RN; 8+ years (MD/PhD/PharmD) or 10+ years (RN) of pharmacovigilance experience in biopharma, with expertise in late-phase clinical development, NDA/BLA submissions, benefit-risk assessment, and safety data review. High-value: Oncology focus with small molecule experience; exposure to Phase 3 clinical trials, regulatory filings, and global pharmacovigilance regulations (FDA, EMA, ICH). Work setup: based in San Francisco or Boston, less than 10% travel.