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 Senior Director of Safety Sciences, you will report to the Vice President, Drug Safety and Pharmacovigilance and play a critical leadership role in building and strengthening Olema’s Safety Science function. As a trusted safety science expert, you will provide strategic and scientific leadership for the planning, implementation, and oversight of patient safety activities across Olema’s growing development portfolio.
What they're looking for
- Minimum of 15 years' relevant experience in drug safety in biopharmaceutical industry and in oncology clinical trials specifically
- Minimum of 6+ years of progressive people leadership experience, including managing, developing, and mentoring high-performing teams
- Experience in oncology is required, small molecule experience is preferred
- Track record of strong individual performance combined with demonstrated success in building, leading, and developing high-performing teams
- Demonstrated ability to coach and develop employees, establish clear expectations, manage performance, and foster a culture of collaboration, accountability, and continuous learning
- Demonstrated experience selecting, managing, and overseeing safety and pharmacovigilance vendors, including establishing performance expectations and ensuring quality, compliance, and accountability
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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