Associate Director, External Data Management

Regeneron is founded on the belief that the right idea, combined with the right team, can lead to significant transformations. Our growing global network is dedicated to inventing, developing, and commercializing medicines that change lives for those with serious diseases. In doing so, we are pioneering innovative approaches to science, manufacturing, and commercialization, as well as redefining our understanding of health. As an Associate Director, External Data Acquisition and Delivery (EDAD), you will provide strategic oversight and operational leadership for External Data Acquisition and Delivery activities across Regeneron’s clinical trial portfolio and initiatives. You will ensure readiness of external data collection platforms, data conformance tools, reconciliation processes, and the delivery of high-quality, compliant external data from third-party vendors including laboratory, biomarker, Digital Health Technologies, imaging, ECG, PK, genomics, and specialty data. You will partner closely with Clinical Data Management, CROs, external vendors, and cross-functional partners to drive external data strategy, operational excellence, vendor oversight, digital transformation initiatives, and process improvements.A Typical Day May Include:Leading External Data Acquisition, integration, quality oversight, and delivery strategy across the clinical trial portfolioServing as a portfolio-level lead for external data quality and clinical-data operational strategyReviewing protocol requirements, vendor specifications, and operational data flowsLeading all aspects of development and maintenance of Data Transfer Specification (DTS) documents to ensure compliance with Regeneron standards and timelinesProviding expert mentorship on external data services including biomarker, eSource, eCOA, imaging, ECG, PK, genomics, and laboratory dataDriving external vendor oversight, onboarding, qualification, governance, and ongoing performance monitoringEstablishing and handling vendor KPIs, SLAs, and quality metricsGoverning reconciliation activities between EDC systems and vendor data platforms to ensure data integrity and consistencyMonitoring reconciliation metrics, discrepancy trends, and resolution timelines across studiesCollaborating with Database Development, Biostatistics, Study Data Managers, and external vendors to resolve complex data discrepanciesLeading process improvement initiatives, automation opportunities, and implementation of innovative external data solutionsManaging and developing a team of EDAD Managers, Specialists, and associates through coaching, mentoring, and performance managementSupporting SOP development, inspection readiness, audit activities, and regulatory complianceRepresenting EDAD in leadership forums, governance committees, and technology discussionsThis Role May Be For You If You Have:Strong expertise managing multiple clinical external data types including biomarker, imaging, eCOA, ECG, PK, genomics, laboratory, and Digital Health Technology dataAdvanced knowledge of external data reconciliation processes and EDC platforms such as Medidata Rave, Veeva, or Oracle InformExperience working with SAS, CSV, and XML data formatsStrong understanding of industry regulations including 21 CFR Part 11, ICH-GCP, and CDISC standardsProven experience handling external vendor relationships and driving accountability for quality deliverablesStrong leadership, people management, coaching, and mentoring capabilitiesStrategic thinking, creativity, problem-solving, and analytical skillsStrong project management and stakeholder management capabilitiesExcellent verbal and written communication skillsAbility to work effectively in a fast-paced, matrixed, and global environmentTo Be Considered For This Role, You Must Have:Minimum 10+ years of experience in Clinical Data Acquisition/Management within biotechnology, pharmaceutical, or healthcare industriesMinimum 4+ years of people management experienceDemonstrated experience overseeing external data reconciliation activities between EDC systems and vendor platformsExperience driving process improvements and vendor oversight in supervised environmentsBachelor’s degree in Science, Health, Mathematics, Computing, Information Systems, or a related fieldAdvanced degree preferredDoes this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location.  In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.  For other countries’ specific benefits, please speak to your recruiter.Please be advised that at Regeneron, we believe we are most successful and work best when we are together.  For that reason, many of Regeneron’s roles are required to be performed on-site.  Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location. 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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company