Director, Clinical Medical Writing

**Join our Mission to Protect Humankind!**

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.

WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:

• RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.
• AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
• LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
• MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.

**Summary:**

Vaxcyte is seeking a Director, Clinical Medical Writing to drive and shape the medical writing processes, procedures, strategies, and document generation and maintenance. This position will lead medical writing activities and will manage contract writers and document QC experts, as well as workflows for document development in Veeva Vault. Key accountabilities include generating documents such as protocol, investigator brochure, informed consent form, pharmacy manual, manuscripts, clinical study reports, etc.), providing guidance on scientific and technical requirements for regulatory documents, contributing towards a style guide for Vaxcyte, and following best practices for authoring of key clinical regulatory documents to meet global regulatory standards. The Director, Clinical Medical Writing will develop new SOPs and templates and contribute towards existing SOPs to support the writing of clinical documents for clinical development activities.

To be successful, the incumbent will be a strong collaborator and communicator, possessing outstanding clinical writing skills and an attitude that fits our culture in a high growth, fast-paced environment.

**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.
• 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 w/ Microsoft Word and PowerPoint; and competent with other Microsoft Office 365 apps, and Veeva Vault. Familiarity with emerging AI-based medical writing tools preferred.