Director, Safety Sciences

Olema Oncology is a clinical‑stage biopharmaceutical company focused on transforming breast cancer care. We are evolving into a fully integrated oncology company, with top‑line data expected later this year and a potential commercial launch in 2027.

Our lead product candidate, palazestrant, is a novel oral estrogen receptor antagonist and degrader, currently in two pivotal Phase 3 trials: OPERA‑01 (monotherapy) and OPERA‑02 (combination with ribociblib). The program targets ER+/HER2- metastatic breast cancer.

We also advance OP‑3136, a KAT6 inhibitor with promising Phase 1 data, and the potential to combine with palazestrant for further value in metastatic disease.

The Director, Safety Sciences reports to the Senior Director, Safety Science and leads strategy for clinical safety data across development, supporting global regulatory submissions and ongoing product development. Duties include preparing safety components for NDA/BLA filings, conducting benefit‑risk assessments, and ensuring compliance with FDA, EMA, ICH, and other requirements.

This role is based in our San Francisco or Boston office and requires less than 10% travel.

Primary responsibilities include:

• Lead the preparation of safety components for NDA/BLA submissions, ensuring alignment with FDA, EMA, and ICH requirements.
• Author and review integrated safety documents, including the Integrated Summary of Safety (ISS), Summary of Clinical Safety (SCS), benefit‑risk assessments, and clinical overviews.
• Collaborate and support in the development of safety narratives, datasets, analyses, and submission‑ready safety deliverables for regulatory filings.
• Conduct comprehensive evaluation and integration of safety data from clinical studies to support overall benefit‑risk assessment for marketing applications.
• Collaborate with Clinical Development, Biostatistics, Regulatory Affairs, Medical Writing, and Programming teams to develop safety strategies and analyses supporting regulatory submissions.
• Prepare and review safety sections of key regulatory documents, including NDA/BLA modules, Investigator Brochures, protocols, informed consent forms, briefing books, and Company Core Data Sheets (CCDS).
• Lead development and maintenance of Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS), and other risk management documents as applicable.
• Participate in preparation and overall regulatory agency meetings (FDA, EMA, PMDA, MHRA, etc.), including safety briefing materials and responses to health authority questions.
• Partner with QA in regulatory inspections and audits, ensuring submission‑related safety documentation is inspection ready.
• Review and interpret safety findings from clinical trials, literature, and post‑marketing data to support regulatory decision‑making and labeling recommendations.
• Contribute to the development of product labeling, including safety sections of prescribing information, package inserts, and related risk communication materials.
• Oversee aggregate safety reporting activities, including DSURs, PBRERs/PSURs, PADERs, and other periodic safety reports required during product development and registration.
• Provide strategic safety input for submission timelines, filing readiness assessments, and regulatory risk mitigation plans.
• Ensure compliance with applicable FDA, EU, ICH, and global pharmacovigilance regulations governing clinical safety and marketing authorization applications.
• Lead cross‑functional safety review meetings and communicate safety findings effectively to internal stakeholders, regulatory authorities, and external partners.

Knowledge

• MD, PhD in medical/biological science, PharmD, or RN degree.
• Small molecule and oncology background required.

Experience

• Minimum 8+ years of pharmacovigilance/drug safety experience in biopharmaceutical industry (MD, PhD, PharmD) or 10+ years for RN.
• Late‑phase clinical development and registration experience, including NDA/BLA submissions and planning.
• Experience with clinical safety data integration and ISS authoring/review.
• Proven experience with benefit‑risk assessments and regulatory justification.
• Experience…