Head of Clinical Data Management

About the role

We're seeking a Head of Clinical Data Management to join our dynamic team. Reporting to the VP, Biometrics, you'll oversee all aspects of Clinical Data Management across our development portfolio, ensuring high-quality data supports drug development.

Responsibilities

• Define and execute strategy for Clinical Data Management support across studies, programs, and evidence generation activities.
• Accountable for quality, consistency, and strategic delivery of all data management activities, including CRF/eCRF design, database build and validation, edit check specifications, data review and cleaning, external data integrations and reconciliations, medical coding, query management, database lock activities, and submission readiness.
• Build, develop, and lead a high-performing Data Management organization with strong operational expertise and leadership bench strength; set priorities, conduct performance evaluations, drive talent development, and oversee resource planning and allocation.
• Establish and maintain robust quality control and risk mitigation frameworks; ensure compliance with industry standards, global regulatory requirements, and internal SOPs; maintain inspection readiness and support regulatory interactions and audits.
• Provide strategic leadership for data management systems, technologies, automation, and innovation initiatives to build scalable, compliant, and future-ready data capabilities within a validated GxP environment.
• Lead modernization initiatives across data management processes and capabilities, including areas such as data integration and reconciliation, centralized and risk-based data review, automation, AI-enabled workflows, metadata-driven processes, and data interoperability.
• Partner closely with Programming, Biostatistics, IT, and Digital teams to advance integrated data and analytics ecosystems.
• Foster strong collaboration within Biometrics and across functions; represent Data Management in key cross-functional forums and enterprise initiatives.

Requirements

• A Master’s degree or PhD in Life Sciences, Computer Science, Data Science, Statistics, or a related discipline and 12+ years of progressive experience in Clinical Data Management within the pharmaceutical or biotechnology industry.
• 8+ years of leadership experience managing teams, functions, and complex development portfolios.
• Deep understanding of the clinical trial data lifecycle, clinical data management processes, GCP and global regulatory requirements, CDISC standards, EDC systems, external data integrations, database lock processes, and inspection readiness expectations.
• Proven experience leading Data Management activities for Phase 2 and Phase 3 global clinical trials, including support for regulatory submissions (NDA/BLA/MAA/PMDA and global filings) and health authority inspections.
• Strong experience with modern clinical data technologies, automation, digital transformation, and innovation initiatives, including building or modernizing data management capabilities, processes, and infrastructure within a validated GxP environment.
• Experience in rare disease, respiratory, immunology, gene therapy, or specialty biotech development programs is preferred.

Qualifications

• Excellent communication, leadership, problem-solving, and organizational change management skills.

Skills

• Strategic thinking
• Operational execution capabilities
• Cross-functional leadership and influence

Benefits

Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP).

Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration.

401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance.

Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back.

Pay

$255,000.00 - $347,500.00 Annual

Schedule

Full-time, remote position.