San Carlos, California, United States · Hybrid
$221k–$258k/yr
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 co…
Skills: Clinical Medical Writing, Regulatory Document Generation, Project Management, Vendor Management, Veeva Vault
Visp, Wallis, Switzerland · On-site
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 co…
Skills: Bioconjugation, Process Engineering, Statistical Data Analysis, GMP Regulations, DOE Planning
San Carlos, California, United States · Remote OK
$174k–$203k/yr
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 co…
Skills: Process Validation, Risk Management, PPQ, CPV, Biologics Manufacturing
San Carlos, California, United States · Hybrid
$215k–$251k/yr
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 co…
Skills: Physical Security Operations, Executive Protection, Access Control, Risk Management, People Management
San Carlos, California, United States · Hybrid
$170k–$200k/yr
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 co…
Skills: Organizational Design, Talent Management, Leadership Coaching, Employee Relations, Workforce Planning
Visp, Wallis, Switzerland · Hybrid
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 co…
Skills: Quality Assurance, GMP, FDA Regulations, EMA Regulations, ICH Guidelines
San Carlos, California, United States · On-site
$51/hr–$56/hr
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 co…
Skills: HPLC/UPLC, SEC, CE, UV-Vis, ELISA
San Carlos, California, United States · Remote OK
$165k–$193k/yr
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 co…
Skills: Drug Substance Commercialization, Conjugation Process, Technical Launch Planning, Regulatory Filings, IND/BLA Authoring
San Carlos, California, United States · On-site
$146k–$171k/yr
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 co…
Skills: Bioconjugation, Tangential Flow Filtration, HPLC, SEC-MALS, Polysaccharide Purification
San Carlos, California, United States · Remote OK
$183k–$194k/yr
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 co…
Skills: Regulatory CMC Strategy, Regulatory Submissions, Health Authority Interaction, BLA Authoring, IND Authoring
San Carlos, California, United States · Remote OK
$165k–$193k/yr
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 co…
Skills: Polysaccharide Manufacturing, Tech Transfer, Process Validation, Biologic Production, Bacterial Fermentation
San Carlos, California, United States · On-site
$102k–$119k/yr
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 co…
Skills: Hazardous Waste Management, Biomedical Waste Management, EHS Compliance, Emergency Response, SDS Database Management
San Carlos, California, United States · On-site
$146k–$171k/yr
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 co…
Skills: Conjugation Process Development, cGMP Manufacturing, Bioprocess Operations, TFF Systems, HPLC
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Lead the development and strategy of clinical medical writing processes, including the generation of protocols, investigator brochures, and clinical study reports. Manage contract writers and QC experts while overseeing document workflows within Veeva Vault to meet global regulatory standards.
Requires an advanced degree (PhD or PharmD preferred) and over 12 years of medical writing experience in biotechnology or clinical research. Must have a proven track record as a lead writer for major US or international regulatory submissions.
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.
Reports to: Sr. Vice President, Clinical Development
Location: San Carlos, CA or Remote Based
Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy): 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.
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.
Vaxcyte is a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. VAX-31, a 31-valent pneumococcal conjugate vaccine (PCV) candidate being evaluated in the OPUS Phase 3 adult clinical program and in a Phase 2 infant clinical program, is being developed for the prevention of invasive pneumococcal disease (IPD) and is the broadest-spectrum PCV candidate in the clinic today. VAX-24, a 24-valent PCV candidate, is designed to cover more serotypes than any infant PCV on-market. VAX-31 and VAX-24 are designed to improve upon standard-of-care PCVs by covering the serotypes in circulation that cause a significant portion of IPD and are associated with high case-fatality rates, antibiotic resistance and meningitis, while maintaining coverage of previously circulating strains. VAX-XL, in earlier-stage development, also leverages the Company’s carrier-sparing, site-specific conjugation technology with the aim of further expanding coverage to deliver the broadest-spectrum candidate in the Company’s PCV franchise. Vaxcyte is re-engineering the way highly complex vaccines are made through XpressCF®, its cell-free protein synthesis platform exclusively licensed from Sutro Biopharma, Inc. Unlike conventional cell-based approaches, the Company’s system for producing difficult-to-make proteins and antigens is intended to accelerate its ability to develop high-fidelity vaccines with enhanced immunological benefits. Vaxcyte’s pipeline also includes VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections, and VAX-GI, a vaccine candidate designed to prevent Shigella.
Offices: 825 Industrial Rd, Suite 300, San Carlos, California 94070, US
Vaxcyte is a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. VAX-31, a 31-valent pneumococcal conjugate vaccine (PCV) candidate being evaluated in the OPUS Phase 3 adult clinical program and in a Phase 2 infant clinical program, is being developed for the prevention of invasive pneumococcal disease (IPD) and is the broadest-spectrum PCV candidate in the clinic today. VAX-24, a 24-valent PCV candidate, is designed to cover more serotypes than any infant PCV on-market. VAX-31 and VAX-24 are designed to improve upon standard-of-care PCVs by covering the serotypes in circulation that cause a significant portion of IPD and are associated with high case-fatality rates, antibiotic resistance and meningitis, while maintaining coverage of previously circulating strains. VAX-XL, in earlier-stage development, also leverages the Company’s carrier-sparing, site-specific conjugation technology with the aim of further expanding coverage to deliver the broadest-spectrum candidate in the Company’s PCV franchise. Vaxcyte is re-engineering the way highly complex vaccines are made through XpressCF®, its cell-free protein synthesis platform exclusively licensed from Sutro Biopharma, Inc. Unlike conventional cell-based approaches, the Company’s system for producing difficult-to-make proteins and antigens is intended to accelerate its ability to develop high-fidelity vaccines with enhanced immunological benefits. Vaxcyte’s pipeline also includes VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections, and VAX-GI, a vaccine candidate designed to prevent Shigella.
Offices: 825 Industrial Rd, Suite 300, San Carlos, California 94070, US
