Associate Director, 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. You will support managing all projects with adherence to compliance of high-quality regulatory submissions—including INDs, NDAs, health authority meeting materials, and other key documents—and contribute to the regulatory and technical writing required throughout the product development lifecycle. This position is based in our Cambridge, MA, or San Francisco, CA office. The role requires approximately 10% travel. Your work will primarily encompass: Translate applicable laws, regulations, and guidance for managing regulatory projects. Implement regulatory strategies supporting compliance that support development programs and business objectives. Supporting the high-quality, timely execution of regulatory activities, deliverables, and milestones. Interact with cross functional project teams to manage and track all regulatory activities and communicate any identified risks to wards compliance of regulatory submission documents, including INDs, NDAs, health authority meeting materials, and related correspondence. Manage the timelines for all regulatory milestones across projects and support regulatory operations for tracking and maintaining submission timelines. Provide remedial actions to any identified risks across projects including any unforeseen situations that can delay or hinder project continuity Review regulatory submissions for accuracy, consistency, completeness, and compliance. Develop and enhance regulatory policies, procedures, and SOPs that support effective and compliant operations. Provide regulatory expertise and documentation support during regulatory and quality inspections. Maintain current knowledge of pharmaceutical development concepts, practices, and regulatory requirements, including applicable provisions of 21 CFR Parts 50, 54, 56, 200, 201, 202, 207, 312, and 314, as well as relevant ICH guidelines. Ideal Candidate Profile >>> Regulatory Compliance Project Management A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge , experience , and attributes for this role. Experience : Bachelor’s degree in a scientific or related discipline; an advanced degree is preferred. 8+ years of Regulatory Compliance and Project Management experience within the pharmaceutical or biotechnology industry. Demonstrated skills to interpret and apply applicable laws, regulations, and