Director, Clinical Medical Writing

Essential Functions

• Provide expertise and leadership in the development of regulatory and clinical documents, including the processes and templates that will ensure sustainable and high-quality deliverables.
• Lead clinical study documentation including but not limited to clinical protocols, investigator brochures, informed consents, various study plans, and clinical study reports.
• Lead cross-functional team discussions to support the development of the above noted clinical trial documents for IND submissions and execution of clinical trials.
• Provide strategy and support in the best practices of medical writing for the development organization.
• Ensure data quality by performing listing reviews per established plans/processes.
• Participate in the selection and oversight of vendors contracted for medical writing services.
• Manage document generation to finalization timelines and budget; proactively participate in budget setting, forecasting, and other aspects of financial management of the trial (vendor accruals).
• Support SOP and process development and improvement.
• Partner across Clinical Operations to embed quality and GCP compliance within day-to-day activities.
• Represent Clinical Medical Writing on cross-functional clinical, regulatory, and submission teams and actively participate in BLA/NDA submission planning and documentation.
• Champion an inclusive mindset and approach, and foster collaboration and consistency across studies and programs.
• Proactively identify risks and develop and implement mitigation strategies.
• Will have management responsibilities.

Requirements

• Advanced degree (Ph.D. or PharmD) preferred, combined with 12+ years of medical writing experience in the clinical research or biotechnology industry. Other combinations of education and/or experience may be considered.
• PREFERRED: Clinical writing experience in clinical vaccine development, with Phase I-III and Phase IV post-marketing experience.
• Experience as lead writer for key documents included in major US and/or international regulatory submissions required.
• Experience managing writing activities for a major US or international regulatory submission (project or people management preferred).
• Proven ability to develop and implement medical writing processes and standards.
• Strong computer skills, project management skills, and a high attention to detail.
• Experience with Zoom and Veeva Vault, preferred.
• Strong communication skills (both written and oral).
• Strong organizational abilities and experience in a multitasking environment.
• A clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission.
• Expert-level skills with Microsoft Word and PowerPoint; and competent with other Microsoft Office 365 apps, and Veeva Vault. Familiarity with emerging AI-based medical writing tools preferred.

Reports to

Sr. Vice President, Clinical Development

Location

San Carlos, CA or Remote Based

Work Arrangement

Hybrid (minimum of 2-3 days per week onsite)/Remote

Compensation

The compensation package will be competitive and includes comprehensive benefits and an equity component.

Salary Range: $221,000 – $258,000 (SF Bay Area). Salary ranges for non-California locations may vary.