Director, External Data Acquisition and Delivery

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.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

• Location:
  
  Warren, NJ
• Work model/flexibility:
  Primarily onsite with hybrid flexibility
• Travel percentage:
  Up to 20%

• 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

• 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 In Form
• Society of Clinical Data Management or ACRP-CP certification is recommended

Does this sound like you? We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.

Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits.

For…