Olema Oncology is a clinical-stage biopharmaceutical company developing novel therapies to transform treatment for metastatic breast cancer and beyond. Backed by Lightspeed.
About the role
As the Director, Safety Sciences reporting to the Senior Director, Safety Science you will provide leadership for the strategy, evaluation, and communication of clinical safety data across the development lifecycle, supporting global regulatory submissions and ongoing product development. Oversee the development of key safety deliverables for NDA/BLA filings, lead integrated benefit-risk assessments, and drive cross-functional alignment on safety strategy and regulatory interactions.
What they're looking for
- Minimum of 8+ (MD, PhD, PharmD) or 10+ (RN) years of pharmacovigilance/drug safety experience in biopharmaceutical industry
- Late phase clinical development and registration experience, NDA/BLA submissions and submission readiness planning
- Experience with clinical safety data integration and ISS authoring/review
- Proven experience with benefit-risk assessments and regulatory justification
- Experience with labeling negotiations and safety labeling strategy
- Demonstrated success leading health authority meeting preparation and regulatory responses
More about this role
Olema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for patients living with breast cancer and beyond. With our transformation into a fully integrated oncology company well underway, it’s an exciting time to be part of Team Olema.
Our lead product candidate, palazestrant, is a novel, orally available complete estrogen receptor antagonist (CERAN) and selective estrogen receptor degrader (SERD) currently in two pivotal Phase 3 clinical trials. We expect top-line data from OPERA-01, our ongoing Phase 3 trial of palazestrant as a monotherapy in patients with second- or third-line ER+/HER2- metastatic breast cancer (MBC), in Q1 2027 which, if positive, could lead to our first potential approval and commercial launch in 2028. OPERA-02, our Phase 3 trial of palazestrant in combination with ribociblib in patients with frontline ER+/HER2- MBC, is enrolling patients. Together with its mechanism of action, pharmacokinetic properties, and the potential to demonstrate activity in both ESR1 wild-type and mutant tumors, palazestrant could transform the metastatic breast cancer treatment paradigm and provide access to...
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