Director, Safety Sciences
Olema Oncology
July 02, 2026
On-site
Boston, MA
Medical Affairs
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; <10% travel.
- Base pay range: $235,000–$255,000; total compensation includes equity, bonus, and benefits.
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; <10% travel.
- Base pay range: $235,000–$255,000; total compensation includes equity, bonus, and benefits.