Director, Safety Sciences
Olema Oncology
August 14, 2026
On-site
Cambridge, MA
Medical Affairs
Director, Safety Sciences
Responsibilities:
- Provide leadership for the strategy, evaluation, and communication of clinical safety data across the development lifecycle.
- Oversee preparation of safety deliverables for NDA/BLA submissions; ensure alignment with FDA, EMA, and ICH.
- Author/review integrated safety documents (ISS, SCS), benefit-risk assessments, and clinical overviews.
- Develop safety narratives, datasets, analyses, and submission-ready safety materials for regulatory filings.
- Integrate safety data to support benefit-risk assessment for marketing applications.
- Collaborate cross-functionally (Clinical Development, Biostatistics, Regulatory Affairs, Medical Writing, Programming) on safety strategies and analyses.
- 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 with safety briefing materials and responses.
- Partner with QA on inspections/audits; ensure inspection-ready safety documentation.
- Review/interpret safety findings to support labeling recommendations and product labeling contributions.
- Oversee aggregate safety reporting (DSURs, PBRERs/PSURs, PADERs, periodic safety reports).
- Provide safety input for submission timelines, filing readiness, and regulatory risk mitigation plans.
- Ensure compliance with FDA/EU/ICH/global pharmacovigilance requirements; lead safety review meetings.
Qualifications/Skills:
- MD, PhD (medical/biological science), PharmD, or RN.
- Small Molecule and Oncology experience is required.
- 8+ years (MD/PhD/PharmD) or 10+ years (RN) pharmacovigilance/drug safety in biopharma.
- Late-phase development/registration and NDA/BLA submission readiness experience.
- ISS authoring/review; clinical safety data integration.
- Benefit-risk assessments, regulatory justification, and safety labeling strategy/negotiations.
- Proven health authority meeting preparation and regulatory response experience.
- Knowledge of FDA/EU/ICH pharmacovigilance guidelines and regulatory response management.
- Clinical database/EDC and CTD/eCTD knowledge; ability to query safety database.
- Experience managing safety vendors/partners; leading/mentoring junior staff.
- Strong analytical, problem-solving, strategic planning, interpersonal, and written/verbal communication skills.
Benefits/Compensation:
- Base pay range: $235,000–$255,000 annually; total compensation includes equity, bonus, and benefits.
Application instructions:
- Not specified.
Responsibilities:
- Provide leadership for the strategy, evaluation, and communication of clinical safety data across the development lifecycle.
- Oversee preparation of safety deliverables for NDA/BLA submissions; ensure alignment with FDA, EMA, and ICH.
- Author/review integrated safety documents (ISS, SCS), benefit-risk assessments, and clinical overviews.
- Develop safety narratives, datasets, analyses, and submission-ready safety materials for regulatory filings.
- Integrate safety data to support benefit-risk assessment for marketing applications.
- Collaborate cross-functionally (Clinical Development, Biostatistics, Regulatory Affairs, Medical Writing, Programming) on safety strategies and analyses.
- 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 with safety briefing materials and responses.
- Partner with QA on inspections/audits; ensure inspection-ready safety documentation.
- Review/interpret safety findings to support labeling recommendations and product labeling contributions.
- Oversee aggregate safety reporting (DSURs, PBRERs/PSURs, PADERs, periodic safety reports).
- Provide safety input for submission timelines, filing readiness, and regulatory risk mitigation plans.
- Ensure compliance with FDA/EU/ICH/global pharmacovigilance requirements; lead safety review meetings.
Qualifications/Skills:
- MD, PhD (medical/biological science), PharmD, or RN.
- Small Molecule and Oncology experience is required.
- 8+ years (MD/PhD/PharmD) or 10+ years (RN) pharmacovigilance/drug safety in biopharma.
- Late-phase development/registration and NDA/BLA submission readiness experience.
- ISS authoring/review; clinical safety data integration.
- Benefit-risk assessments, regulatory justification, and safety labeling strategy/negotiations.
- Proven health authority meeting preparation and regulatory response experience.
- Knowledge of FDA/EU/ICH pharmacovigilance guidelines and regulatory response management.
- Clinical database/EDC and CTD/eCTD knowledge; ability to query safety database.
- Experience managing safety vendors/partners; leading/mentoring junior staff.
- Strong analytical, problem-solving, strategic planning, interpersonal, and written/verbal communication skills.
Benefits/Compensation:
- Base pay range: $235,000–$255,000 annually; total compensation includes equity, bonus, and benefits.
Application instructions:
- Not specified.