Director, Safety Sciences
Olema Oncology
July 02, 2026
On-site
San Francisco, CA
Medical Affairs
Director, Safety Sciences
Responsibilities:
- Lead strategy, evaluation, and communication of clinical safety data across the development lifecycle to support global regulatory submissions and product development.
- Oversee key safety deliverables for NDA/BLA filings; lead integrated benefit-risk assessments and cross-functional alignment on safety strategy and regulatory interactions.
- Author/review integrated safety documents (ISS, SCS, benefit-risk assessments, clinical overviews) and develop submission-ready safety narratives, datasets, analyses, and clinical safety evaluations.
- Prepare/review safety sections of regulatory documents (NDA/BLA modules, Investigator Brochures, protocols, informed consent forms, briefing books, CCDS).
- Lead development/maintenance of RMPs, REMS, and other risk management documents.
- Support health authority meetings; partner with QA for inspections/audits.
- Review safety findings for regulatory decision-making and labeling recommendations; contribute to product labeling.
- Oversee aggregate safety reporting (DSURs, PBRERs/PSURs, PADERs, periodic safety reports) and provide regulatory risk mitigation input.
Qualifications / Skills:
- MD/PhD (medical/biological science), PharmD, or RN.
- Small molecule and oncology experience required.
- 8+ years (MD/PhD/PharmD) or 10+ years (RN) pharmacovigilance/drug safety in biopharma.
- Late-phase development/registration experience; NDA/BLA submission readiness planning.
- Experience integrating clinical safety data; ISS authoring/review; benefit-risk assessments; safety labeling strategy.
- Ability to apply FDA/EU/ICH pharmacovigilance guidance; CTD/eCTD and clinical database/EDC knowledge.
- Strong written/verbal communication, analytical/problem-solving, strategic planning, and ethical judgment.
Compensation:
- Base pay range: $235,000–$255,000 annually; total compensation includes equity, bonus, and benefits.
Responsibilities:
- Lead strategy, evaluation, and communication of clinical safety data across the development lifecycle to support global regulatory submissions and product development.
- Oversee key safety deliverables for NDA/BLA filings; lead integrated benefit-risk assessments and cross-functional alignment on safety strategy and regulatory interactions.
- Author/review integrated safety documents (ISS, SCS, benefit-risk assessments, clinical overviews) and develop submission-ready safety narratives, datasets, analyses, and clinical safety evaluations.
- Prepare/review safety sections of regulatory documents (NDA/BLA modules, Investigator Brochures, protocols, informed consent forms, briefing books, CCDS).
- Lead development/maintenance of RMPs, REMS, and other risk management documents.
- Support health authority meetings; partner with QA for inspections/audits.
- Review safety findings for regulatory decision-making and labeling recommendations; contribute to product labeling.
- Oversee aggregate safety reporting (DSURs, PBRERs/PSURs, PADERs, periodic safety reports) and provide regulatory risk mitigation input.
Qualifications / Skills:
- MD/PhD (medical/biological science), PharmD, or RN.
- Small molecule and oncology experience required.
- 8+ years (MD/PhD/PharmD) or 10+ years (RN) pharmacovigilance/drug safety in biopharma.
- Late-phase development/registration experience; NDA/BLA submission readiness planning.
- Experience integrating clinical safety data; ISS authoring/review; benefit-risk assessments; safety labeling strategy.
- Ability to apply FDA/EU/ICH pharmacovigilance guidance; CTD/eCTD and clinical database/EDC knowledge.
- Strong written/verbal communication, analytical/problem-solving, strategic planning, and ethical judgment.
Compensation:
- Base pay range: $235,000–$255,000 annually; total compensation includes equity, bonus, and benefits.