Senior Director, Global Clinical Data Management (Biotechnology)

Location: Remote or onsite depending on the candidate’s geographic location and offer letter; Monday–Friday during standard business hours, with flexibility subject to manager approval.

Annual base pay: $230,000–$253,000 in national markets or $260,000–$280,000 in premium markets, including Los Angeles, San Diego, San Francisco, New York City, Chicago, and Boston. The role is also eligible for a discretionary bonus and equity award.

Company

Vertically integrated commercial-stage biotechnology company developing immunotherapies, cell therapies, cancer vaccines, and infectious-disease treatments.

What you will do

• Define and execute the global Clinical Data Management strategy across Phase I–IV clinical trials.
• Lead end-to-end data management operations, including CRF design, database builds, edit-check strategies, and database locks.
• Establish enterprise data standards, governance frameworks, quality systems, and audit-ready processes aligned with GCP, FDA, EMA, and ICH requirements.
• Oversee CROs, FSPs, and other external partners to ensure timely, cost-effective, and high-quality delivery.
• Drive inspection readiness, regulatory audit support, data lineage, traceability, and clinical dataset quality.
• Lead automation, AI-enabled data review, advanced clinical data platform, budget, resource forecasting, and vendor-contract initiatives.

Requirements

• Bachelor’s or Master’s degree in life sciences or a technical discipline.
• 12+ years of experience in clinical data, clinical operations, or healthcare data systems.
• Strong enterprise data governance experience and expertise in multi-study portfolio management.
• Deep knowledge of EDC systems, CDMS platforms, and SDTM/CDISC standards.
• Working knowledge of clinical research, GCP, and regulatory requirements, with strong FDA/EMA inspection experience.
• Experience developing and managing teams with direct and indirect reports, including leadership-level talent management.

Nice to have

• Experience managing a global team.

Culture & Benefits

• Collaborative environment with opportunities to work across different company functions.
• Professional development opportunities within a growing, publicly traded biopharmaceutical company.
• Medical, dental, and vision plan options, plus health and financial wellness programs.
• 401(k) retirement plan with company match, flexible spending accounts, life and disability coverage, and an employee assistance program.
• Paid time off, holidays, education savings support, legal services, identity theft protection, pet insurance, and employee discounts.