Director, Safety Sciences
Olema Oncology
August 14, 2026
On-site
San Francisco, CA
Medical Affairs
About the Role: Director, Safety Sciences
Responsibilities:
- Provide leadership for the strategy, evaluation, and communication of clinical safety data across the development lifecycle.
- Oversee development of safety deliverables for NDA/BLA filings; lead integrated benefit-risk assessments; drive cross-functional alignment on safety strategy and regulatory interactions.
- Ensure compliance with FDA, EMA, ICH, and other global regulatory requirements; enable proactive risk management.
- Prepare and review safety components and documents for submissions (e.g., ISS, SCS, benefit-risk assessments, clinical overviews).
- Develop safety narratives, datasets, analyses, and submission-ready deliverables; conduct integration of safety data for benefit-risk assessment.
- Prepare safety sections of key regulatory documents (e.g., CTD/eCTD modules, protocols, informed consent forms, Investigator Brochures, CCDS).
- Lead development/maintenance of RMPs and REMS.
- Support regulatory agency meetings; prepare safety briefing materials and responses.
- Partner with QA for inspections/audits; ensure documentation is inspection ready.
- Oversee aggregate safety reporting (e.g., DSURs, PBRERs/PSURs, PADERs).
- Provide strategic safety input for timelines, filing readiness, and regulatory risk mitigation; lead safety review meetings.
Qualifications:
- 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 experience in biopharma.
- Late phase clinical development/registration; NDA/BLA submissions and readiness planning.
- Experience integrating clinical safety data and ISS authoring/review.
- Proven benefit-risk assessment and regulatory justification; labeling strategy/negotiations.
- Ability to apply FDA/EU/ICH pharmacovigilance guidance; regulatory response management.
- CTD/eCTD knowledge; familiarity with EDC/clinical databases and safety database work for case review.
- Experience managing safety vendors; leading/mentoring junior team members; process improvement/SOP development.
Skills/Attributes:
- Time management, prioritization, strong verbal/written communication, analytical/problem-solving, strategic planning, ethical judgment.
Compensation/Benefits (if applicable):
- Base pay range: $235,000–$255,000 annually; total compensation may include equity, bonus, and benefits.
Application instructions:
- No additional application instructions provided.
Responsibilities:
- Provide leadership for the strategy, evaluation, and communication of clinical safety data across the development lifecycle.
- Oversee development of safety deliverables for NDA/BLA filings; lead integrated benefit-risk assessments; drive cross-functional alignment on safety strategy and regulatory interactions.
- Ensure compliance with FDA, EMA, ICH, and other global regulatory requirements; enable proactive risk management.
- Prepare and review safety components and documents for submissions (e.g., ISS, SCS, benefit-risk assessments, clinical overviews).
- Develop safety narratives, datasets, analyses, and submission-ready deliverables; conduct integration of safety data for benefit-risk assessment.
- Prepare safety sections of key regulatory documents (e.g., CTD/eCTD modules, protocols, informed consent forms, Investigator Brochures, CCDS).
- Lead development/maintenance of RMPs and REMS.
- Support regulatory agency meetings; prepare safety briefing materials and responses.
- Partner with QA for inspections/audits; ensure documentation is inspection ready.
- Oversee aggregate safety reporting (e.g., DSURs, PBRERs/PSURs, PADERs).
- Provide strategic safety input for timelines, filing readiness, and regulatory risk mitigation; lead safety review meetings.
Qualifications:
- 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 experience in biopharma.
- Late phase clinical development/registration; NDA/BLA submissions and readiness planning.
- Experience integrating clinical safety data and ISS authoring/review.
- Proven benefit-risk assessment and regulatory justification; labeling strategy/negotiations.
- Ability to apply FDA/EU/ICH pharmacovigilance guidance; regulatory response management.
- CTD/eCTD knowledge; familiarity with EDC/clinical databases and safety database work for case review.
- Experience managing safety vendors; leading/mentoring junior team members; process improvement/SOP development.
Skills/Attributes:
- Time management, prioritization, strong verbal/written communication, analytical/problem-solving, strategic planning, ethical judgment.
Compensation/Benefits (if applicable):
- Base pay range: $235,000–$255,000 annually; total compensation may include equity, bonus, and benefits.
Application instructions:
- No additional application instructions provided.