Executive Director, Clinical Data Management

Kardigan is a heart health company seeking an Executive Director, Clinical Data Management to lead the strategic and operational direction of the Clinical Data Management function across the clinical development portfolio.

Requirements

• Bachelor's degree required, advanced degree preferred in Life Sciences, Data Science, Biomedical Engineering, Informatics, or related field.
• 12+ years of experience in Clinical Data Management, Clinical Operations or Biometrics within biopharma, biotech, CRO, or health technology.
• Experience leading teams across multiple locations and geographic regions preferred.
• Extensive experience in drug development and working with regulatory agencies such as FDA and EMA.
• Proficiency in CDISC requirements for regulatory submissions, including expertise with preparation and submission of data in CDISC - STDM/ADaM, CDASH.
• Strong understanding of EDC systems, data standards, and end-to-end data management processes and governing regulatory expectations (ICH, 21CFR Part 11).
• Excellent collaborator, communicator (verbal & written), and influencer across technical and non-technical audiences.
• Detail and process oriented and demonstration of strong project management skills.

Benefits

• 4 days per week on-site work schedule
• Up to 20-30% domestic and international travel as required
• Paid holidays
• Generous Paid Time Off
• 401k Matching
• Retirement Plan