Senior Director, Commercial Manufacturing and Operations

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 a $15 billion global market opportunity. Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with the potential to generate further value and meaningfully impact the metastatic breast cancer treatment landscape – particularly in combination with palazestrant. We recently presented encouraging Phase 1 monotherapy data from this program across multiple solid tumor types, are advancing patient enrollment in the ongoing combination arms in MBC, and expect to initiate a Phase 1 study of OP-3136 in combination with Bayer's darolutamide in metastatic castration-resistant prostate cancer by the end of this year. Aspiring to transform the metastatic treatment paradigm is an ambitious endeavor that requires a resolute approach to developing better therapies and passionate colleagues dedicated to helping the patients we serve feel better, longer. Team Olema possesses a deep commitment to a shared purpose, the sustained pursuit of excellence, cultivating the courage required to advance our programs, the drive to succeed, and a collective capacity for adaptability through learning, growth, and evolution. We are a small group of nimble self-starters who bring consistency in our quest for the extraordinary every single day. If you're ready to be part of a tenacious, courageous, agile, and growing team, join us in making a profound impact, together – for our patients, for your career, and for what's beyond. ABOUT THE ROLE The Senior Director, Commercial Manufacturing & Operations is Olema's senior leader accountable for building, scaling and governing the commercial manufacturing and supply platform for palazestrant. The role owns end-to-end commercial supply, spanning drug substance (DS), drug product (DP), packaging, labeling, serialization, inventory and distribution, and ensures uninterrupted, cost-effective supply to Olema's 3PL and specialty pharmacy network. The Senior Director will set the commercial supply strategy, liaison with executive leadership, and own and executes the planning, inventory, vendor and logistics work behind it, then build the team as the business grows. KEY RESPONSIBILITIES Commercial Supply Strategy & Launch Readiness Set the commercial supply strategy for palazestrant, including network design, capacity and second-source planning, and the launch inventory build (including at-risk manufacturing and packaging decisions). Own the commercial supply budget, COGS inputs, supply cost KPIs and tariff exposure in partnership with Finance. Lead supply-side launch readiness from NDA submission through PDUFA and market entry; maintain the launch risk register and present status, risks and mitigation options to executive leadership. Manufacturing & CDMO Governance (DS & DP) Provide business and operational oversight of …

View the full posting and apply