Director, External Data Acquisition and Delivery
When & where:
• Location: Warren, NJ
• Work model/flexibility: Primarily onsite with hybrid flexibility
• Travel percentage: Up to 20%
Discover your role:
• Set the strategic direction for external data acquisition, integration, and reconciliation across all therapeutic areas
• Own portfolio-level governance of external data quality, data integrity, and risk
• Own and mature the model for data management, including qualification, onboarding, operational readiness, ongoing performance monitoring, and governance for clinical data management domain in collaboration with the cross-functional team.
• Guide Data Transfer Specifications, external data management plans, and review plans with cross-functional partners
• Set EDC-to-vendor reconciliation standards that keep our processes inspection-ready and compliant with ICH-GCP and 21 CFR Part 11
• Advance new data capabilities, digital health technologies, and automation with Digital & Tech and Data Technology and Innovation
• Lead, coach, and develop a global team of Associate Directors, managers, specialists, and associates
• Represent Regeneron in industry forums such as CDISC and SCDM, and deputize for the Global Head as needed
This role requires:
• Bachelor's degree (advanced degree preferred) in Science, Health, Mathematics, Computing, Information Systems, Data Management, or a related field with 12+ years of progressive experience in clinical data acquisition/management, external data operations.
• 5+ years of people leadership, including managing managers or senior professionals
• Experience leading external data vendor oversight, data transfer specification governance, and external data reconciliation in a regulated environment
• Advanced knowledge of ICH-GCP, 21 CFR Part 11, CDISC standards, and EDC platforms such as Medidata Rave, Veeva, or Oracle InForm
• Society of Clinical Data Management or ACRP-CP certification is recommended
Salary Range (annually)
$183,100.00 - $305,200.00