Director, Safety Sciences

Director, Safety Sciences Responsibilities

• Lead strategy, evaluation, and communication of clinical safety data across the development lifecycle, supporting global regulatory submissions and product development.
• Oversee safety deliverables for NDA/BLA filings; lead integrated benefit-risk assessments; drive cross-functional alignment on safety strategy and regulatory interactions.
• Author/review integrated safety documents (ISS, SCS), benefit-risk assessments, and clinical overviews; develop safety narratives, datasets, analyses, and submission-ready deliverables.
• Evaluate and integrate safety data to support benefit-risk for marketing applications.
• Collaborate with Clinical Development, Biostatistics, Regulatory Affairs, Medical Writing, and Programming to develop safety strategies/analyses.
• Prepare/review safety sections of regulatory documents (NDA/BLA modules, Investigator Brochures, protocols, informed consent forms, briefing books, CCDS).
• Lead Risk Management Plans (RMPs), REMS, and other risk management documents; participate in health authority meetings and respond to questions.
• Partner with QA for inspections/audits; review safety findings from clinical/literature/post‑marketing data to support regulatory decisions and labeling.
• Contribute to product labeling safety sections and oversee aggregate safety reporting (DSURs, PBRERs/PSURs, PADERs).

• MD/PhD (medical/biological science), PharmD, or RN;
  Small Molecule and Oncology required.
• 8+ years (MD/PhD/PharmD) or 10+ years (RN) pharmacovigilance/drug safety experience in biopharma.
• Late‑phase clinical development/registration; NDA/BLA submission readiness; ISS authoring/review.
• Proven benefit‑risk and regulatory justification; labeling strategy/negotiations; experience preparing for health authority meetings.
• Working knowledge of FDA/EU/ICH pharmacovigilance; CTD/eCTD; clinical database/EDC; safety database queries.
• Manage/mentor junior team; lead safety vendor management; contribute to process improvements.

• Strong communication, analytical/problem‑solving, strategic planning; time management; ethical judgment; fast learner.

Based in San Francisco or Boston;