Director, Clinical Medical Writing

About the Role Vaxcyte is seeking a Director, Clinical Medical Writing to lead and shape the medical writing function across regulatory and clinical documents, ensuring high-quality submissions and effective collaboration in a fast-paced clinical development environment. This role will oversee the medical writing team and contract writers, manage document QC activities, and drive workflows in Veeva Vault.

What You'll Do

• Provide expertise and leadership in the development of regulatory and clinical documents, including processes and templates to ensure sustainable, high-quality deliverables.
• Lead clinical study documentation (protocols, investigator brochures, informed consent forms, study plans, clinical study reports) and cross-functional discussions to support IND submissions and trial execution.
• Develop and implement medical writing strategies and best practices within the development organization; ensure data quality through listing reviews per plans.
• Manage vendor selection/oversight for medical writing services and oversee document generation to finalization timelines and budgets (vendor accruals).
• Collaborate with Clinical Operations to embed quality and GCP compliance; represent Clinical Medical Writing on cross-functional teams and participate in BLA/NDA submission planning.
• Develop or influence SOPs and templates; contribute to process improvements and a culture of inclusion, collaboration, and consistency across programs.
• Proactively identify risks and implement mitigation strategies; manage staff responsibilities and performance as part of a growing organization.

What We're Looking For

• Advanced degree (Ph.D. or PharmD) with 12+ years of medical writing experience in clinical research or biotechnology (alternative combinations considered).
• Preferred vaccine development experience (Phase I–III and Phase IV) and track record as lead writer for major regulatory submissions (US and/or international).
• Experience managing writing activities for major regulatory submissions (project or people management).
• Demonstrated ability to develop and implement medical writing processes and standards; strong project management, data quality, and attention to detail.
• Proficiency with Zoom and Veeva Vault preferred; strong Microsoft Word, PowerPoint (Office 365) skills; excellent written and oral communication; ability to work in a multitasking, high-growth environment.
• Thorough understanding of clinical development from protocol design through regulatory submission; familiarity with AI-based medical writing tools preferred.
• Location: San Carlos, CA or remote; reports to Sr. VP, Clinical Development.

Nice to Have

• Familiarity with emerging AI-based medical writing tools.

Compensation & Benefits

• Salary range: $221,000–$258,000 (SF Bay Area). The compensation package includes comprehensive benefits and an equity component.