About this role
Director, Safety Sciences at Olema Oncology. Location: San Francisco or Boston. Role: leading submissions, authoring documents, managing safety Requirements: Lead safety strategy and deliverables for NDA/BLA filings; author integrated safety documents; 8+ years pharmacovigilance (MD/PhD/PharmD) or 10+ years (RN); experience with late-phase development, ISS authoring, benefit-risk, and regulatory interactions. Category: Healthcare Services - Advanced Practice Seniority: Senior Level Tools: EDC, CTD/eCTD, safety database, Company Core Data Sheets (CCDS) Commitment: Full Time Workplace: Onsite Languages: English