Associate Director – Data and Knowledge Management

🔥 16 hours ago

🏄 California – Remote

🏄 California – Remote

💵 $183k - $214k / year

⏰ Full Time

🟠 Senior

👔 Director

🦅 H1B Visa Sponsor

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Vaxcyte

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2013

🧬 Biotechnology

💊 Pharmaceuticals

Biotechnology • Pharmaceuticals

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to prevent and treat serious bacterial infections. The company develops broad-spectrum conjugate and novel protein vaccines—using modern synthetic chemistry and a proprietary cell-free protein synthesis platform licensed from Sutro Biopharma—to create difficult-to-make protein antigens more efficiently. Its lead programs are pneumococcal conjugate vaccine candidates VAX-31 (31-valent) and VAX-24 (24-valent) in Phase 2/3 studies, with earlier-stage candidates targeting Group A Strep and Shigella; Vaxcyte focuses on reducing invasive bacterial disease burden, antibiotic resistance consequences, and related morbidity in vulnerable populations.

📋 Description

• Acquire and gather data from manufacturing nodes throughout the supply chain to enable regulatory filings, process monitoring, and continuous improvement. • Develop and oversee data management strategies to support operations, development, and regulatory submissions. • 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 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 minimum 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.

🏖️ Benefits

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