Director, Safety Sciences

Olema Oncology•Boston, MA

21h•Hybrid

About The Position

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. It’s an exciting time to be part of Team Olema, with our transformation into a fully integrated oncology company well underway, top-line data from our lead program expected later this year, and our first potential commercial launch on the horizon. 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 the fall which, if successful, could lead to our first potential approval and commercial launch in 2027. 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 has the potential to transform the metastatic breast cancer treatment paradigm and access 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 reported encouraging Phase 1 monotherapy data from this program across multiple solid tumor types and are advancing patient enrollment in the ongoing combination arms in MBC. Aspiring to transform the metastatic treatment paradigm is an ambitious endeavor that requires a resolute approach to developing better therapies and a passionate team dedicated to helping the patients we serve feel better, longer. We possess a deep commitment to our shared purpose, the sustained pursuit of excellence, cultivating the courage required to advance our programs, drive to succeed, and a collective capacity for adaptability through learning, growth, and evolution. Team Olema is made up of nimble self-starters who bring consistency in their 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 >>> Director, Safety Sciences As the Director, Safety Sciences reporting to the Senior Director, Safety Science you will provide leadership for the strategy, evaluation, and communication of clinical safety data across the development lifecycle, supporting global regulatory submissions and ongoing product development. Oversee the development of key safety deliverables for NDA/BLA filings, lead integrated benefit-risk assessments, and drive cross-functional alignment on safety strategy and regulatory interactions. Ensure compliance with FDA, EMA, ICH, and other global regulatory requirements while enabling proactive risk management and informed benefit-risk decision-making. This role is based out of our San Francisco or Boston office and will require less than 10% travel.

Requirements

MD, PhD in the field of medical/biological science, PharmD, or RN degree
Small Molecule and Oncology is a must
Minimum of 8+ (MD, PhD, PharmD) or 10+ (RN) years of pharmacovigilance/drug safety experience in biopharmaceutical industry
Late phase clinical development and registration experience; NDA/BLA submissions and submission readiness planning
Experience with clinical safety data integration and ISS authoring/review
Proven experience with benefit-risk assessments and regulatory justification
Experience with labeling negotiations and safety labeling strategy
Demonstrated success leading health authority meeting preparation and regulatory responses
Ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities, along with regulatory response management
Familiar with the clinical database/EDC, CTD/eCTD knowledge
Ability to work with the safety database for purposes of clinical/medical case review and simple queries
Experience working with business partners and managing safety vendors
Track record of leading, managing, mentoring and teaching new/junior team members
Actively participated in process improvement initiatives e.g. the development and maintenance of relevant SOPs and supporting documents
Able to manage time effectively, prioritize competing tasks, and consistently meet deadlines
Strong verbal and written skills to convey safety findings and recommendations with clarity
Excellent analytical, problem-solving, strategic planning, and interpersonal skills
Self-motivated and enthusiastic; fast learner who can identify the core project challenges and expeditiously change courses as required in a fast-paced organization
Demonstrates sound judgment, professionalism, and strong ethical standards

Responsibilities

Lead the preparation of safety components for NDA/BLA submissions, ensuring alignment with FDA, EMA, and ICH requirements.
Author and review integrated safety documents, including the Integrated Summary of Safety (ISS), Summary of Clinical Safety (SCS), benefit-risk assessments, and clinical overviews.
Collaborate and support in the development of safety narratives, datasets, analyses, and submission-ready safety deliverables for regulatory filings.
Conduct comprehensive evaluation and integration of safety data from clinical studies to support overall benefit-risk assessment for marketing applications.
Collaborate with Clinical Development, Biostatistics, Regulatory Affairs, Medical Writing, and Programming teams to develop safety strategies and analyses supporting regulatory submissions.
Prepare and review safety sections of key regulatory documents, including NDA/BLA modules, Investigator Brochures, protocols, informed consent forms, briefing books, and Company Core Data Sheets (CCDS).
Lead development and maintenance of Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS), and other risk management documents as applicable.
Participate in preparation and overall regulatory agency meetings (FDA, EMA, PMDA, MHRA, etc.), including safety briefing materials and responses to health authority questions.
Partner with QA in regulatory inspections and audits, ensuring submission-related safety documentation is inspection ready.
Review and interpret safety findings from clinical trials, literature, and post-marketing data to support regulatory decision-making and labeling recommendations.
Contribute to the development of product labeling, including safety sections of prescribing information, package inserts, and related risk communication materials.
Oversee aggregate safety reporting activities, including DSURs, PBRERs/PSURs, PADERs, and other periodic safety reports required during product development and registration.
Provide strategic safety input for submission timelines, filing readiness assessments, and regulatory risk mitigation plans.
Ensure compliance with applicable FDA, EU, ICH, and global pharmacovigilance regulations governing clinical safety and marketing authorization applications.
Lead cross-functional safety review meetings and communicate safety findings effectively to internal stakeholders, regulatory authorities, and external partners.