Associate Director – Data and Knowledge Management

This is a fully remote position, open to applicants in California.

📋 Description

• Collect and consolidate data from manufacturing nodes across the supply chain to facilitate regulatory filings, monitor processes, and drive continuous improvement.

• Design and manage data management strategies that support operations, development, and regulatory submissions.

• Take ownership of data verification for all commercial regulatory submissions.

• Direct the integration of both structured and unstructured data across various departments (e.g., preclinical, clinical, regulatory, CMC).

• Create systems and workflows to capture and preserve organizational knowledge, encompassing protocols, study outcomes, lessons learned, and decision rationales.

• Develop tools and processes that empower scientific teams to efficiently locate, share, and reuse knowledge.

• Advocate for a culture of knowledge sharing within scientific and operational functions.

• Collaborate with regulatory, quality, R&D, IT, and contract manufacturing teams to identify data and knowledge needs and align appropriate solutions.

• Spearhead cross-functional initiatives aimed at digital transformation, data harmonization, and collaboration tools.

• Oversee and mentor a team of data professionals, analysts, and knowledge specialists.

• Ensure timely access to high-quality data for operational decision-making.

• Collaborate with the data science team to enhance data visualization, reporting, and insights.

• Facilitate the use of AI/ML and automation for enhanced data analysis and knowledge extraction.

• Maintain compliance with data protection and clinical trial regulations, including GDPR, HIPAA, and 21 CFR Part 11.

• Identify and address risks related to data security, access, and retention.

⛳️ Requirements

• Bachelor’s, Master’s, or PhD degree in Life Sciences, Data Science, Information Management, or a related field. A minimum of 9+ years of relevant experience for Ph.D. holders, 11+ years for M.S./M.A. graduates, or 14+ years for B.S./B.A. graduates.

• Over 8 years of experience in data and/or knowledge management, including at least 3 years in a life sciences or biotech environment.

• Demonstrated experience in leading enterprise data governance and knowledge sharing initiatives within a highly regulated setting.

• Strong project management and communication skills; capable of working collaboratively with scientific and operational teams.

• Familiarity with tools such as SharePoint, Veeva Vault, Confluence, Tableau, and SQL is highly desirable.

• Experience in supporting clinical trials and regulatory submissions (e.g., IND, BLA) is strongly preferred.

• A 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 along with an equity component.