Global Regulatory Affairs, Compliance and Project Management

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 >>> Associate Director, Global Regulatory Affairs, Compliance and Project Management 

As the Global Associate Director, Regulatory Affairs, compliance and project management reporting to the Senior Director, Global Regulatory Strategy, you will play a key role in the managing projects designed towards advancing Olema’s development programs and helping bring innovative therapies to patients.  The role involves oversight of all regulatory compliance activities. You will partner cross-functionally to manage the projects of all Olema assets in development and post approval.  Implement strategies to ensure compliance with applicable laws, regulations, and guidance documents for regulatory submissions and regulatory operational activities.