Director, External Data Acquisition and Delivery
Regeneron Pharmaceuticals
Summary
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Director, External Data Acquisition and Delivery to join our Clinical Data Management. This role provides senior leadership for vendor and provider oversight for data and tech, external data reconciliation, data transfer specifications, external data acquisition capabilities, external data integrity, and inspection readiness across all data types. In this role, you will shape how laboratory, biomarker, eCOA, imaging, genomics, and digital health data are acquired, reconciled, and delivered with quality and speed. You will collaborate with vendors, technology teams, Quality, Procurement, and cross-functional partners while developing a high-performing across multiple regions.
Job description
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
Requirements
- Bachelor's degree in Science, Health, Mathematics, Computing, Information Systems, Data Management, or related field
- 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
Benefits
- Annual bonuses
- Incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Medical, Dental & Vision
- Life and disability insurance
- Paid time off
- Family support benefits
Company overview
Regeneron Pharmaceuticals is a leading American biotechnology company founded in 1988 and headquartered in Tarrytown, New York. The company specializes in inventing, developing, and commercializing life-transforming medicines for people with serious diseases. Regeneron is renowned for its innovative antibody technologies and has developed several groundbreaking therapies, including EYLEA® for retinal diseases, DUPIXENT® for inflammatory conditions, and the COVID-19 antibody cocktail REGEN-COV®. The company operates with a strong focus on research and development across multiple therapeutic areas including ophthalmology, oncology, cardiovascular diseases, and rare genetic disorders. Regeneron's proprietary VelocImmune® technology platform enables the rapid generation of fully human monoclonal antibodies. With over 15,000 employees globally and annual revenues exceeding $14 billion, Regeneron has established itself as a major force in the biotechnology industry, consistently ranking among the top-performing pharmaceutical companies and maintaining a robust pipeline of investigational therapies.