Summary:
As we grow, we are seeking a strategic and collaborative Associate Director of Data and Knowledge Management to ensure the integrity, accessibility, and effective use of data and knowledge assets across the organization.
The Associate Director of Data and Knowledge Management will lead enterprise-wide efforts to structure, govern, and utilize data and knowledge resources critical to our process development, clinical, regulatory, and operational activities. This role is instrumental in ensuring scientific data integrity, regulatory readiness, and the preservation of institutional knowledge in a dynamic, fast-paced clinical environment.
Essential Functions:
Data Management, Strategy & Governance:
- 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).
Knowledge Management:
- 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.
Collaboration & Leadership:
- 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.
Analytics & Insights:
- 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.
Compliance & Risk Management:
- 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.
Reports to: Senior Director, Process Validation
Location: Cary, North Carolina, San Carlos, California or Philadelphia, Pennsylvania
Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy):
Hybrid (Cary, North Carolina or San Carlos, California or Philadelphia, Pennsylvania) (minimum of 3 days per week onsite)
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $183,000 - $214,000 (SF Bay Area). Salary ranges for non-California locations may vary.