Senior Director, Patient Safety Sciences

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 >>> Senior Director, Patient Safety Sciences   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.  You will lead, develop, and inspire a high-performing team, establish clear priorities, strengthening capabilities, and fostering a culture of accountability, collaboration, and continuous learning. Working closely with colleagues across Clinical Development, Regulatory Affairs, Medical Affairs, and other functions, you will ensure that safety considerations are integrated into program strategy and decision-making. You will also represent Olema’s safety perspective in engagements with external stakeholders, including investigators, partners, and regulatory agencies.  This is an opportunity to shape a growing function, develop talented safety professionals, and make a meaningful contribution to the advancement of innovative therapies for patients with cancer.  This role is based out of our San Francisco or Boston office and will require minimal travel .  Your work will primarily encompass:  Lead the strategic planning and execution of Olema’s patient safety activities, including cross-functional collaboration with key departments. Recommend pharmacovigilance and risk-management strategies and lead signal detection, assessment, and evaluation activities.   Lead the development and authoring of safety-related sections of clinical and regulatory documents, including benefit-risk assessments, protocols, Investigator’s Brochures, informed consent forms, briefing books, core safety information, and other internal and external documents.  Provide clinical and medical review of serious adverse events (SAEs), suspected unexpected, serious adverse reactions (SUSARs), and analyses of similar events, as required. Responsibilities include reviewing source records and case narratives for accuracy; evaluating MedDRA coding; identifying medically relevant queries; determining expectedness based on reference safety information; preparing sponsor assessments; and guiding Drug Safety colleagues in determining reportability.  Provide safety expertise and leadership in Data Monitoring Committee meetings, including the preparation, review, and interpretation of relevant safety data.  Lead Safety Sciences activities related to quality systems, audits, inspection readiness, and regulatory inspections, ensuring the function maintains a consistent state of compliance and preparedness.  Develop and deliver safety-related training for employees, cross-functional partners, and clinical site personnel, promoting shared accountability for patient safety and regulatory compliance.  Build, lead, and develop a high-performing Safety Sciences team. Provide coaching and mentorship to direct reports and junior team members; establish clear goals and expectations; delegate responsibilities effectively; monitor performance and workload; and foster accountability, professional growth, collaboration, and continuous improvement.