Associate Director, Clinical Medical Writing
Vaxcyte
San Carlos, CA, USA
Posted on Saturday, July 15, 2023
Company Profile:
Vaxcyte, Inc. (Nasdaq: PCVX) is a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. The Company is developing broad-spectrum conjugate and novel protein vaccines to prevent or treat bacterial infectious diseases. Vaxcyte’s lead candidate, VAX-24, is a 24-valent, broad-spectrum, carrier-sparing pneumococcal conjugate vaccine (PCV) being developed for the prevention of invasive pneumococcal disease (IPD). The Company is re-engineering the way highly complex immunizations are made through modern synthetic techniques, including advanced chemistry and our exclusively licensed XpressCFTM cell-free protein synthesis platform. Unlike conventional cell-based approaches, the Company’s system for producing difficult-to-make proteins and antigens is intended to accelerate its ability to efficiently create and deliver high-fidelity vaccines with enhanced immunological benefits. Vaxcyte’s pipeline also includes VAX-31, a 31-valent PCV candidate; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease; and VAX-GI, a vaccine program designed to prevent Shigella. The Company is driven to eradicate or treat invasive bacterial infections, which have serious and costly health consequences when left unchecked. For more information, visit www.vaxcyte.com.
Vaxcyte, headquartered in San Carlos, CA, went public in June 2020 and currently has a team of approximately 180 employees and anticipates continued, significant growth. Following equity offerings in October 2022 and April 2023, which generated over $1.1 billion in net proceeds, the Company’s balance sheet is further strengthened to advance its pipeline of novel vaccines, including VAX-24. These financings followed positive data readouts from Vaxcyte’s Phase 1/2 proof-of-concept study evaluating VAX-24 in adults aged 18-64 and Phase 2 study in adults 65 and older. The Company believes these results support a best-in-class potential for VAX-24, which was designed to replace the current standard-of-care in adults and children. VAX-24 is being investigated for the prevention of IPD, which can be most serious for infants, young children, older adults and those with immune deficiencies or certain chronic health conditions. Given the global impact of pneumococcal disease remains significant, the public health community continues to advocate for vaccines that can offer broader protection to prevent IPD. Vaxcyte’s PCV franchise, consisting of VAX-24 and VAX-31, is designed specifically to address this need and has the potential to deliver the broadest protection for this very serious disease. We believe that our PCVs could receive regulatory approval based on successful completion of clinical studies utilizing well-defined surrogate immune endpoints, consistent with how other PCVs have obtained regulatory approval in the past, rather than requiring clinical field efficacy studies.
Summary:
Vaxcyte is seeking an Associate Director of Clinical Medical Writing to be responsible for driving and shaping the medical writing processes, procedures, strategies, document generation and maintenance. This position will lead all 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[JS1] , 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. They 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. The position will be remotely based with some travel to the San Carlos, CA office.
Essential Functions:
- 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.
- 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.
- Champion an inclusive mindset and approach, and foster collaboration and consistency across studies and programs.
- Proactively identify risks and develop and implement mitigation strategies.
Requirements:
- Preferred clinical writing experience in clinical vaccine development.
- Level commensurate with experience.
- Advanced degree (Ph.D. or PharmD) preferred, combined with 10+ years of medical writing experience in the clinical research or biotechnology industry.
- 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).
- 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).
- 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.
- Ability to travel up to 30% domestic and international.
- Models our Core Values: is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted.
- All Vaxcyte employees require vaccination against COVID-19.
Reports to: Vice President of Clinical Operations
Location: San Carlos, CA
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $200,000 - $206,000
Send resumes to:
Vaxcyte, Inc.
825 Industrial Road, Suite 300
San Carlos, CA 94070
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.