About this role
About the Role Director, Safety Sciences at Olema Oncology, based in Boston, MA. You will lead the safety sciences strategy for palazestrant (CERAN and SERD) across its Phase 3 program, collaborating with Clinical Development, Regulatory, and Safety teams to ensure patient safety and robust risk management as Olema advances toward potential commercial launch. What You'll Do
- Provide strategic leadership for safety sciences across palazestrant’s Phase 3 trials (OPERA-01 and other pivotal studies).
- Oversee safety data collection, signal detection, and risk assessment to inform benefit-risk decisions.
- Partner with cross-functional teams to develop safety surveillance plans, aggregate safety data, and prepare safety narratives for regulatory submissions.
- Ensure compliant safety reporting and pharmacovigilance activities aligned with company and regulatory requirements. What We're Looking For
- Advanced degree (MD, DO, PharmD, PhD) with significant experience in safety/pharmacovigilance in oncology.
- Demonstrated leadership in safety sciences within Phase 3 clinical programs, preferably in targeted therapies or CERAN/SERD modalities.
- Strong collaboration and communication skills; ability to influence across clinical, regulatory, and translational teams.
- Proven track record of high-quality safety data review, risk assessment, and regulatory interactions.