Director, Clinical Data Management

Director, Head of Clinical Data Management

Job Responsibilities:
- Lead the Clinical Data Management function, providing strategic and operational oversight across the clinical portfolio.
- Serve as Data Management lead for a high-priority program with hands-on involvement in study execution, data review, issue resolution, and risk management.
- Lead NDA/BLA submission activities (readiness, data standards compliance, inspection preparedness).
- Partner with Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, Safety, and Regulatory Affairs to support study execution and data quality.
- Oversee CROs/vendors to ensure quality, compliance, accountability, timelines, and deliverables.
- Lead cross-functional data review and key data management documentation (Data Management Plans, edit checks, validation specs, reconciliation plans, data transfer agreements).
- Develop scalable data management processes/standards/governance/SOPs; manage risks and competing priorities.
- Build and expand the Clinical Data Management team.
- Travel ~10%; evening/weekend work involved.

Skills & Knowledge:
- EDC systems experience (Medidata RAVE or Veeva).
- GCP; CDISC/CDASH; ICH guidelines; FDA regulations.
- Excellent communication; strong analytical/problem-solving.

Basic Requirements:
- BS/MS in Life Sciences, CS, Math, Health Sciences, or related field.
- 10+ years data management experience in pharma/biotech/CRO.
- Demonstrated team leadership/mentoring.
- Oncology therapeutic area experience.
- Proven CRO relationship management and data management deliverables oversight.
- Experience with AI-enabled tools.

Preferred Requirements:
- Veeva EDC system experience.
- Radiopharmaceutical experience.

Benefits (as listed):
- Health Coverage (medical, pharmacy, dental, vision).
- Wellbeing support programs.
- Financial protection (401(k), disability, life insurance, etc.).
- Paid Time Off (flexible time off/paid vacation varies by employee group).