Director, Safety Sciences
Olema Oncology
July 02, 2026
On-site
Cambridge, MA
Medical Affairs
Director, Safety Sciences
Responsibilities:
- Lead strategy, evaluation, and communication of clinical safety data across the development lifecycle, supporting global regulatory submissions.
- Oversee key safety deliverables for NDA/BLA filings; lead integrated benefit-risk assessments; ensure cross-functional alignment on safety strategy and regulatory interactions.
- Author/review integrated safety documents (ISS, SCS, benefit-risk assessments, clinical overviews) and develop safety narratives, datasets, analyses, and submission-ready deliverables.
- Evaluate and integrate safety data to support benefit-risk for marketing applications; develop safety strategies and analyses with Clinical Development, Biostatistics, Regulatory Affairs, Medical Writing, and Programming.
- Prepare/review safety sections of regulatory documents (NDA/BLA modules, Investigator Brochures, protocols, informed consent forms, briefing books, CCDS).
- Develop/maintain RMPs, REMS, and other risk management documents as applicable.
- Support preparation for and participation in regulatory agency meetings; lead safety briefing materials and responses to health authority questions.
- Partner with QA on inspections/audits; review safety findings to support regulatory decisions and labeling recommendations.
- Contribute to product labeling and oversee aggregate safety reporting (DSURs, PBRERs/PSURs, PADERs, and other periodic reports).
- Provide strategic safety input on timelines/filing readiness and regulatory risk mitigation; lead safety review meetings.
Qualifications/Skills:
- MD, PhD (medical/biological science), PharmD, or RN; Small Molecule and Oncology is required.
- 8+ years (MD/PhD/PharmD) or 10+ years (RN) pharmacovigilance/drug safety in biopharmaceutical industry.
- Late phase clinical development/registration; NDA/BLA submission readiness planning.
- Experience integrating clinical safety data and ISS authoring/review; strong benefit-risk assessment and regulatory justification.
- Labeling strategy/negotiations; experience preparing for health authority meetings and regulatory responses.
- Knowledge of FDA/EU/ICH pharmacovigilance requirements; regulatory response management.
- Familiarity with clinical database/EDC; CTD/eCTD; ability to query safety databases.
- Experience managing safety vendors/partners; leadership/mentoring of junior team members; experience with SOP/process improvement.
Attributes:
- Time management, prioritization, strong verbal/written communication, analytical/problem-solving, strategic planning, strong ethics.
Location/Travel:
- San Francisco or Boston office; <10% travel.
Compensation/Benefits:
- Base pay range expected: $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, supporting global regulatory submissions.
- Oversee key safety deliverables for NDA/BLA filings; lead integrated benefit-risk assessments; ensure cross-functional alignment on safety strategy and regulatory interactions.
- Author/review integrated safety documents (ISS, SCS, benefit-risk assessments, clinical overviews) and develop safety narratives, datasets, analyses, and submission-ready deliverables.
- Evaluate and integrate safety data to support benefit-risk for marketing applications; develop safety strategies and analyses with Clinical Development, Biostatistics, Regulatory Affairs, Medical Writing, and Programming.
- Prepare/review safety sections of regulatory documents (NDA/BLA modules, Investigator Brochures, protocols, informed consent forms, briefing books, CCDS).
- Develop/maintain RMPs, REMS, and other risk management documents as applicable.
- Support preparation for and participation in regulatory agency meetings; lead safety briefing materials and responses to health authority questions.
- Partner with QA on inspections/audits; review safety findings to support regulatory decisions and labeling recommendations.
- Contribute to product labeling and oversee aggregate safety reporting (DSURs, PBRERs/PSURs, PADERs, and other periodic reports).
- Provide strategic safety input on timelines/filing readiness and regulatory risk mitigation; lead safety review meetings.
Qualifications/Skills:
- MD, PhD (medical/biological science), PharmD, or RN; Small Molecule and Oncology is required.
- 8+ years (MD/PhD/PharmD) or 10+ years (RN) pharmacovigilance/drug safety in biopharmaceutical industry.
- Late phase clinical development/registration; NDA/BLA submission readiness planning.
- Experience integrating clinical safety data and ISS authoring/review; strong benefit-risk assessment and regulatory justification.
- Labeling strategy/negotiations; experience preparing for health authority meetings and regulatory responses.
- Knowledge of FDA/EU/ICH pharmacovigilance requirements; regulatory response management.
- Familiarity with clinical database/EDC; CTD/eCTD; ability to query safety databases.
- Experience managing safety vendors/partners; leadership/mentoring of junior team members; experience with SOP/process improvement.
Attributes:
- Time management, prioritization, strong verbal/written communication, analytical/problem-solving, strategic planning, strong ethics.
Location/Travel:
- San Francisco or Boston office; <10% travel.
Compensation/Benefits:
- Base pay range expected: $235,000–$255,000 annually; total compensation includes equity, bonus, and benefits.