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Job description
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).
Qualifications
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.
Attributes
Strong communication, analytical/problem‑solving, strategic planning; time management; ethical judgment; fast learner.
Application / Location
Based in San Francisco or Boston; Base pay range: $235,000–$255,000; total compensation includes equity, bonus, and benefits.
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Worksite address
boston, MA, 02298, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.