Strategic Lead, External Data Acquisition & Delivery

Regeneron Pharmaceuticals

Warren (MI)

Hybrid

USD 155,000 - 253,000

Full time

14 days+

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Job summary

Regeneron Pharmaceuticals in Warren, NJ, is seeking an Associate Director, External Data Acquisition and Delivery (EDAD) to provide strategic oversight and operational leadership for external data activities across the clinical trial portfolio. This role partners with CDM, CROs, and vendors to drive data strategy, governance, and process improvements, with hybrid onsite work and up to 25% travel.

The ideal candidate will lead data integration, reconciliation, and data transfer specifications,

Qualifications

Minimum 10+ years of experience in Clinical Data Acquisition/Management within biotechnology, pharmaceutical, or healthcare industries.
Minimum 4+ years of people management experience.
Demonstrated experience overseeing external data reconciliation activities between EDC systems and vendor platforms.
Experience driving process improvements and vendor oversight in supervised environments.
Bachelor’s degree in Science, Health, Mathematics, Computing, Information Systems, or a related field.
Advanced degree preferred.

Responsibilities

Leading External Data Acquisition, integration, quality oversight, and delivery strategy across the clinical trial portfolio.
Serving as a portfolio-level lead for external data quality and clinical-data operational strategy.
Reviewing protocol requirements, vendor specifications, and operational data flows.
Leading all aspects of development and maintenance of Data Transfer Specification (DTS) documents to ensure compliance with Regeneron standards and timelines.
Providing expert mentorship on external data services including biomarker, eSource, eCOA, imaging, ECG, PK, genomics, and laboratory data.
Driving external vendor oversight, onboarding, qualification, governance, and ongoing performance monitoring.
Establishing and handling vendor KPIs, SLAs, and quality metrics.
Governing reconciliation activities between EDC systems and vendor data platforms to ensure data integrity and consistency.
Monitoring reconciliation metrics, discrepancy trends, and resolution timelines across studies.
Collaborating with Database Development, Biostatistics, Study Data Managers, and external vendors to resolve complex data discrepancies.
Leading process improvement initiatives, automation opportunities, and implementation of innovative external data solutions.
Managing and developing a team of EDAD Managers, Specialists, and associates through coaching, mentoring, and performance management.
Supporting SOP development, inspection readiness, audit activities, and regulatory compliance.
Representing EDAD in leadership forums, governance committees, and technology discussions.