Olema Oncology
Director, Safety Sciences
San Francisco, California · Director
Sponsorship not specified$235k-$255kDetected 20 days ago
Process ImprovementClinical TrialsFDA RegulatoryPharmacovigilanceLeadershipCommunicationProblem SolvingMentoringAdaptabilityBiostatisticsRegulatory Affairs
About the role
- 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.
- OPERA-02, our Phase 3 trial of palazestrant in combination with ribociblib in patients with frontline ER+/HER2- MBC, is enrolling patients.
- 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.
Responsibilities
- Lead the preparation of safety components for NDA/BLA submissions, ensuring alignment with FDA, EMA, and ICH requirements.
- Collaborate and support in the development of safety narratives, datasets, analyses, and submission-ready safety deliverables for regulatory filings.
- 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.
- 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.
- Lead cross-functional safety review meetings and communicate safety findings effectively to internal stakeholders, regulatory authorities, and external partners.
- Experience working with business partners and managing safety vendors
- 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
Requirements
- Oversee aggregate safety reporting activities, including DSURs, PBRERs/PSURs, PADERs, and other periodic safety reports required during product development and registration.
- Experience with clinical safety data integration and ISS authoring/review
- Experience with labeling negotiations and safety labeling strategy
Compensation
- The base pay range for this position is expected to be $235,000 - $255,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience.
Benefits
- Author and review integrated safety documents, including the Integrated Summary of Safety (ISS), Summary of Clinical Safety (SCS), benefit-risk assessments, and clinical overviews.
- 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.
- Participate in preparation and overall regulatory agency meetings (FDA, EMA, PMDA, MHRA, etc.), including safety briefing materials and responses to health authority questions.
- Proven experience with benefit-risk assessments and regulatory justification
- Demonstrated success leading health authority meeting preparation and regulatory responses
- Ability to work with the safety database for purposes of clinical/medical case review and simple queries
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