Associate Director of Data and Knowledge Management
Join Vaxcyte, a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from bacterial diseases such as invasive pneumococcal disease, Group A Strep, and Shigella. Our mission is to eradicate or treat serious bacterial infections through creative, high-integrity science and collaboration.
About the Role
The Associate Director of Data and Knowledge Management will lead enterprise-wide efforts to structure, govern, and utilize data and knowledge assets critical to process development, clinical, regulatory, and operational activities. This role ensures scientific data integrity, regulatory readiness, and the preservation of institutional knowledge in a dynamic, fast-paced clinical environment.
Responsibilities
- Develop and oversee data management strategies to support operations, development, and regulatory submissions.
- Acquire and gather data from manufacturing nodes throughout the supply chain to enable regulatory filings, process monitoring, and continuous improvement.
- Own data verification for all commercial regulatory submissions.
- Lead the integration of structured and unstructured data across departments (e.g., preclinical, clinical, regulatory, CMC).
- Build systems and workflows to capture and retain organizational knowledge, including protocols, study results, lessons learned, and decision rationales.
- Develop tools and processes that enable scientific teams to find, share, and reuse knowledge efficiently.
- Champion a knowledge-sharing culture across scientific and operational functions.
- Partner with regulatory, quality, R&D, IT, and contract manufacturing teams to understand data and knowledge needs and align solutions.
- Lead cross-functional initiatives focused on digital transformation, data harmonization, and collaboration tools.
- Manage and mentor a team of data professionals, analysts, and knowledge specialists.
- Ensure timely access to high-quality data for operational decision-making.
- Partner with the data science team to drive data visualization, reporting, and insights.
- Support the use of AI/ML and automation for improved data analysis and knowledge extraction.
- Ensure compliance with data protection and clinical trial regulations, including GDPR, HIPAA, and 21 CFR Part 11.
- Identify and mitigate risks related to data security, access, and retention.
Requirements
- Bachelor’s, Master’s, or PhD degree in Life Sciences, Data Science, Information Management, or related field.
- Minimum of 9+ years of relevant experience for Ph.D., 11+ years for M.S./M.A., or 14+ years for B.S./B.A.
- 8+ years of experience in data and/or knowledge management, with a minimum of 3 years in a life sciences or biotech setting.
- Proven experience leading enterprise data governance and knowledge-sharing initiatives in a highly regulated environment.
- Strong project management and communication skills; able to work cross-functionally with scientific and operational teams.
- Experience with tools like SharePoint, Veeva Vault, Confluence, Tableau, and SQL is highly desirable.
- Experience supporting clinical trials and regulatory submissions (e.g., IND, BLA) strongly preferred.
- Background in immunology, vaccines, or infectious disease R&D is highly preferred.
- Experience in scaling systems and processes in a high-growth, early- to mid-stage biotech company is preferred.
Core Values
- Rethink Convention: Bring creative and intellectual diversity to innovate and re-innovate vaccine delivery.
- Aim High: Embrace our audacious goal to courageously make the most complex biologics ever attempted.
- Lead with Heart: Foster a kindness-first, inclusive approach to collaboration and vigorous debate.
- Model Excellence: Demonstrate integrity, accountability, equality, and clarity in communications and decision-making.
Benefits
The compensation package includes comprehensive benefits and an equity component.
Pay
Salary Range: $183,000 – $214,000 (SF Bay Area). Salary ranges for non-California locations may vary.
Schedule
Work Arrangement: Remote in California or North Carolina.