AD/Director, Clinical Data Sciences

Role Summary

AD/Director, Clinical Data Sciences — leadership role driving program execution of data science deliverables, ensuring data integrity and regulatory compliance within a fast-paced clinical development environment.

Responsibilities

• Serve as the accountable data sciences leader for key programs, ensuring proactive risk management and issue resolution.
• Develop and execute the clinical data sciences strategy to support program pipeline and portfolio goals.
• Oversee end-to-end data management activities from study start-up through submission, including protocol development, database design, data cleaning, and lock.
• Ensure timely and accurate delivery of clinical data to support interim analyses, database locks, and regulatory submissions.
• Ensure study documentation and filing is maintained in an inspection ready state and provide leadership and direct support as required for audits and regulatory inspections.
• Oversee vendor partnerships (CROs, EDC providers, and other data service partners) and ensure adherence to timelines, budgets, and quality standards.
• Promote a culture of quality, innovation, and collaboration across operations and development functions.
• Drive process optimization and digital transformation initiatives.
• Provide direct study support as may be required to support business objectives.
• Lead and mentor a high-performing clinical data sciences team.
• Support establishment and maintenance of data standards in accordance with industry guidelines.
• Complete other duties assigned by manager.

Qualifications

• B.A./B.S. or M.A./M.B.A. degree in Biology, Health Sciences, or related scientific field required.
• 10+ years in clinical data management/sciences within the pharmaceutical or biopharma industry.
• Prior leadership experience managing teams and overseeing multiple studies.
• Oncology experience.
• Extensive experience in managing external vendors (CROs, central laboratories, etc).
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Demonstrated expertise in EDC systems (Veeva EDC, Medidata Rave, etc.), data visualization platforms, and CDISC standards.
• Excellent communication skills.
• Analytical thinker with a data-driven mindset and attention to detail.
• Knowledge of health authorities‚Äô rules and regulations governing clinical data collection, storage, transmission, and privacy.
• Flexibility to travel approximately 5-10% of time.

Skills

• Leadership and team mentorship
• Clinical data management and data sciences
• Regulatory compliance and audits
• Vendor and project management
• EDC systems and CDISC standards
• Data visualization and analytical thinking

Education

• B.A./B.S. or M.A./M.B.A. in Biology, Health Sciences, or related field

Additional Requirements

• Travel: 5-10% of time