Director, Safety Sciences

Role: Lead the strategy, evaluation, and communication of clinical safety data for Olema's oncology pipeline, supporting global regulatory submissions and ongoing development. Responsibilities: prepare safety components for NDA/BLA filings, author and review safety documents (ISS, SCS), conduct benefit-risk assessments, develop safety narratives and datasets, support safety strategy and regulatory interactions, oversee safety reporting (DSURs, PBRERs/PSURs), and ensure compliance with FDA, EMA, ICH, and global pharmacovigilance regulations. Collaborate with Clinical Development, Biostatistics, Regulatory Affairs, Medical Writing, and other teams to facilitate safety data integration and regulatory readiness. Lead safety aspects of labeling, risk management plans, and agency meetings, contributing to overall benefit-risk profiles and safety communication. Requirements: MD, PhD, PharmD, or RN with expertise in small molecules and oncology; 8+ years (MD/PhD/PharmD) or 10+ years (RN) in pharmacovigilance/drug safety, with late-phase clinical development and regulatory submission experience. Proven success in safety data integration, benefit-risk assessment, and regulatory strategy, including NDA/BLA processes. Preferred: experience in oncology, solid tumor indication, and familiarity with clinical data systems and safety databases. High-value specifics include oncology (breast cancer), Phase 3 development, NDA/BLA preparation, and global regulatory compliance. Work setup: based in San Francisco or Boston, with less than 10% travel.