Executive Director, Clinical Data Acquisition

Role Summary

The Executive Director, Clinical Data Acquisition leads a team responsible for strategic and operational data collection across all clinical studies (Phase I–IV). The role focuses on data standards, policies, and high-quality data capture through EDC systems, while managing external vendors and developing the CDA function to meet current and future needs. The incumbent represents Clinical Data Management and Data Science & Biometrics in leadership capacities and collaborates with senior R&D leaders to ensure compliant, timely, and high-quality data delivery across the portfolio.

Responsibilities

• Define and drive the vision for optimized data collection utilizing latest technologies, ensuring regulatory compliance and timely, high-quality data generation.
• Oversee end-to-end CDA activities including data standards, eCRF development, external data transfers/integration, reconciliation, and validation of data systems and repositories.
• Provide day-to-day leadership of the CDA team (employees, contractors, vendors) to foster proactive engagement and collaboration with CDM, DSB, IT, Procurement, Development Operations, Clinical Development, Global Patient Safety, and others.
• Maintain record retention strategies for clinical data and documentation in accordance with global regulations and policies, including archival of data at sites and storage in repositories (e.g., eTMF).
• Drive quality, efficiency, and innovation at the study and portfolio level to meet deliverables within timelines, budget, and quality standards; contribute to protocol, database, validation, and data management plan design.
• Establish governance structures with vendors to ensure quality oversight of deliverables and relationships across the portfolio.
• Lead data standardization initiatives to ensure regulatory compliance and alignment with industry standards (e.g., CDISC) and internal policies.
• Develop and implement continuous process improvement by monitoring KPIs, quality, and timeliness of study deliverables.
• Foster cross-functional senior leadership engagement to deliver solutions for new service capabilities.
• Contribute to departmental and study budgets, including forecasting and cost accruals.
• Identify and resolve operational problems to remove barriers to study execution.
• Support study teams during regulatory submissions and inspections, including oversight processes and issue mitigation.
• Promote customer focus and maintain a positive, value-based work environment aligned with company values; lead and inspire teams through change.
• Stay current with regulatory and industry advances; represent the company in data management and data strategy to establish CDM as an industry leader.
• May perform day-to-day tactical responsibilities to ensure successful execution of clinical studies.

Qualifications

• BS/BA in a related discipline with 18+ years of related experience; or
• MS/MA in a related discipline with 16+ years of related experience; or
• PhD in a related discipline with 15+ years of related experience; or
• Equivalent combination of education and experience. Certification in the assigned area may be required.

Experience

• Typically requires 18+ years of related experience in Biotech/Pharmaceutical industry; Oncology clinical trials experience preferred.
• Experience leading major change initiatives preferred.
• Demonstrated experience leading global data management and/or technical teams required.
• Experience participating in regulatory submissions and inspections required.
• Minimum of 12 years of line management experience required.

Skills

• Extensive experience in the specialty; strong understanding of clinical development, quality, regulatory standards (CDISC), and data management policies (GCP, ICH).
• Ability to develop technical or business solutions to complex problems; provide guidance for major programs and teams.
• Strong analytical and business communication skills; ability to train staff on data management SOPs and guidelines.
• Knowledge of Good Clinical Practices (GCP) and experience managing external data management activities.
• Independent judgment in methods and evaluation; ability to build formal networks across groups.

Education

• BS/BA, MS/MA, or PhD in a related discipline as detailed above; certification in the assigned area may be required.