Associate Director – Data and Knowledge Management

Role Overview

• 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.

Tech Stack

• SQL
• Tableau
• Vault

Benefits

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