Director, Safety Sciences
Olema Oncology
August 15, 2026
On-site
Boston, MA
Medical Affairs
Director, Safety Sciences
Responsibilities:
- Lead strategy, evaluation, and communication of clinical safety data across the development lifecycle.
- Oversee key safety deliverables for NDA/BLA filings; lead integrated benefit-risk assessments.
- Author/review integrated safety documents (ISS, SCS), benefit-risk assessments, and clinical overviews.
- Develop safety narratives, datasets, analyses, and submission-ready safety deliverables for regulatory filings.
- Evaluate and integrate safety data to support benefit-risk assessment for marketing applications.
- Collaborate cross-functionally (Clinical Development, Biostatistics, Regulatory Affairs, Medical Writing, Programming) on safety strategy and submission analyses.
- Prepare/review safety sections of regulatory documents (CTD/eCTD modules, Investigator Brochures, protocols, informed consent forms, briefing books, CCDS).
- Develop/maintain Risk Management Plans (RMPs), REMS, and related risk management documents.
- Support regulatory agency meetings with safety briefing materials and responses.
- Partner with QA for inspections/audits; ensure submission-related documentation is inspection ready.
- Review/interpreting safety findings from trials, literature, and post-marketing data for regulatory decisions and labeling.
- Oversee aggregate safety reporting (DSURs, PBRERs/PSURs, PADERs, and periodic reports).
- Provide safety input for submission timelines, readiness, and regulatory risk mitigation.
- Lead cross-functional safety reviews and communicate findings to stakeholders.
Qualifications/Requirements:
- MD/PhD in medical/biological science, PharmD, or RN.
- Small Molecule and Oncology experience is required.
- 8+ (MD/PhD/PharmD) or 10+ (RN) years pharmacovigilance/drug safety experience in biopharma.
- Late-phase development/registration; NDA/BLA submissions and readiness planning.
- Clinical safety data integration; ISS authoring/review.
- Benefit-risk assessment/regulatory justification; labeling negotiations and safety labeling strategy.
- Experience with health authority meeting prep and regulatory responses.
- Working knowledge of FDA/EU/ICH pharmacovigilance requirements and regulatory response management.
- Clinical database/EDC and CTD/eCTD knowledge; ability to use safety database for case review.
- Manage safety vendors/partners; lead/mentor/jointly teach junior team members.
- Process improvement experience (e.g., SOP development/maintenance).
Skills/Attributes:
- Time management, prioritization, and deadline adherence.
- Strong written/verbal communication; analytical, problem-solving, strategic planning, interpersonal skills.
- Self-motivated, fast learner, sound judgment, professionalism, ethical standards.
Location/Travel:
- San Francisco or Boston; less than 10% travel.
Compensation/Benefits:
- Base pay range: $235,000–$255,000 annually; total compensation includes equity, bonus, and benefits.
Application Instructions:
- None provided in the posting.
Responsibilities:
- Lead strategy, evaluation, and communication of clinical safety data across the development lifecycle.
- Oversee key safety deliverables for NDA/BLA filings; lead integrated benefit-risk assessments.
- Author/review integrated safety documents (ISS, SCS), benefit-risk assessments, and clinical overviews.
- Develop safety narratives, datasets, analyses, and submission-ready safety deliverables for regulatory filings.
- Evaluate and integrate safety data to support benefit-risk assessment for marketing applications.
- Collaborate cross-functionally (Clinical Development, Biostatistics, Regulatory Affairs, Medical Writing, Programming) on safety strategy and submission analyses.
- Prepare/review safety sections of regulatory documents (CTD/eCTD modules, Investigator Brochures, protocols, informed consent forms, briefing books, CCDS).
- Develop/maintain Risk Management Plans (RMPs), REMS, and related risk management documents.
- Support regulatory agency meetings with safety briefing materials and responses.
- Partner with QA for inspections/audits; ensure submission-related documentation is inspection ready.
- Review/interpreting safety findings from trials, literature, and post-marketing data for regulatory decisions and labeling.
- Oversee aggregate safety reporting (DSURs, PBRERs/PSURs, PADERs, and periodic reports).
- Provide safety input for submission timelines, readiness, and regulatory risk mitigation.
- Lead cross-functional safety reviews and communicate findings to stakeholders.
Qualifications/Requirements:
- MD/PhD in medical/biological science, PharmD, or RN.
- Small Molecule and Oncology experience is required.
- 8+ (MD/PhD/PharmD) or 10+ (RN) years pharmacovigilance/drug safety experience in biopharma.
- Late-phase development/registration; NDA/BLA submissions and readiness planning.
- Clinical safety data integration; ISS authoring/review.
- Benefit-risk assessment/regulatory justification; labeling negotiations and safety labeling strategy.
- Experience with health authority meeting prep and regulatory responses.
- Working knowledge of FDA/EU/ICH pharmacovigilance requirements and regulatory response management.
- Clinical database/EDC and CTD/eCTD knowledge; ability to use safety database for case review.
- Manage safety vendors/partners; lead/mentor/jointly teach junior team members.
- Process improvement experience (e.g., SOP development/maintenance).
Skills/Attributes:
- Time management, prioritization, and deadline adherence.
- Strong written/verbal communication; analytical, problem-solving, strategic planning, interpersonal skills.
- Self-motivated, fast learner, sound judgment, professionalism, ethical standards.
Location/Travel:
- San Francisco or Boston; less than 10% travel.
Compensation/Benefits:
- Base pay range: $235,000–$255,000 annually; total compensation includes equity, bonus, and benefits.
Application Instructions:
- None provided in the posting.