About this role
About the Role Director, Safety Sciences will lead safety sciences for Olema Oncology’s clinical development programs, with a focus on palazestrant. This role sits within a rapidly transforming oncology company committed to delivering safer therapies for breast cancer and beyond and will partner across Clinical, Regulatory, and Pharmacovigilance to shape safety strategy and data generation through two pivotal Phase 3 trials. What You'll Do
- Lead safety sciences activities for palazestrant across Phase 3 trials, including safety signal assessment, risk management planning, and data generation
- Collaborate with Cross-functional teams (Clinical Development, Regulatory, Pharmacovigilance, Biostatistics, Medical Affairs) to ensure safety data aligns with regulatory expectations
- Oversee safety data collection, analysis, and reporting for ongoing trials and contribute to safety sections of regulatory submissions and top-line data presentations
- Ensure compliance with ICH/GCP and pharmacovigilance standards What We're Looking For
- Significant experience leading safety sciences or pharmacovigilance in oncology drug development
- Proven ability to collaborate with cross-functional teams and communicate safety risks effectively
- Experience with Phase 3 clinical programs and regulatory submissions
- Strong strategic thinking and leadership skills