Sr. Director, Clinical Medical Writing

Role: Director of Clinical Medical Writing responsible for leading the development and management of regulatory clinical documents for vaccine candidates in a fast-paced, biotech environment. Responsibilities: oversee medical writing processes, manage contract writers, generate key documents like protocols, IBs, informed consent forms, and clinical study reports; develop SOPs and templates; ensure compliance with global regulatory standards; support BLA/NDA submissions; collaborate with cross-functional teams; and manage timelines and budgets. Requirements: Ph.D. or PharmD with 12+ years' experience in clinical research or biotech, particularly in vaccine development (Phases I-IV, post-marketing), with proven leadership in regulatory document authorship and management. Strong expertise in clinical development processes, GxP compliance, and experience with Veeva Vault, Microsoft Office, and emerging AI writing tools is preferred. High-value specifics: vaccine modality, clinical phases, US and international regulatory submissions, and experience managing vendor relationships. Location: San Carlos, CA or remote with hybrid work arrangement; some travel may be required.