Director, Clinical Data Management

Director, Head of Clinical Data Management

Job Responsibilities
- Lead the Clinical Data Management function across the clinical portfolio.
- Serve as Data Management lead for a high-priority program: hands-on study execution, data review, issue resolution, and risk management.
- Lead NDA/BLA submission activities: submission readiness, data standards compliance, regulatory inspection preparedness.
- Partner cross-functionally (Clinical Ops, Biostatistics, Statistical Programming, Medical Monitoring, Safety, Regulatory Affairs) to meet data quality objectives.
- Oversee CROs/vendors to ensure quality, compliance, timelines, and deliverables.
- Lead cross-functional data reviews; oversee data management documentation (Data Management Plans, edit checks, validation specs, reconciliation plans, data transfer agreements).
- Develop scalable data management processes, standards, governance, and SOPs.
- Manage competing priorities; proactively identify risks and mitigation strategies.
- Build and expand the Clinical Data Management team.

Skills & Qualifications
- Strong EDC experience (Medidata RAVE or Veeva).
- GCP, CDISC/CDASH, ICH guidelines, and FDA regulations.
- Excellent written/verbal communication; strong analytical/problem-solving skills.
- BS/MS in Life Sciences, Computer Science, Mathematics, Health Sciences, or related field.
- 10+ years data management experience in pharma/biotech/CRO.
- Proven oncology therapeutic area experience.
- Team leadership/mentoring experience.
- Proven CRO relationship management; AI-enabled tools experience.

Preferred
- Veeva EDC; radiopharmaceutical experience.

Benefits (as stated)
- Health coverage (medical/pharmacy/dental/vision), wellbeing support, and 401(k) with disability/life and related protection.
- Paid time off (flexible time off or annual vacation per location/role type).