Associate Director, External Data Acquisition and Delivery

Build our future together at Regeneron, where we use science and innovation to develop life-changing medicines for people with serious diseases. Join our Clinical Data Management team as an Associate Director of External Data Acquisition and Delivery (EDAD).

About the role

Provide strategic oversight and operational leadership for External Data Acquisition and Delivery activities across Regeneron’s clinical trial portfolio and initiatives. 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. 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.

Responsibilities

• Lead External Data Acquisition, integration, quality oversight, and delivery strategy across the clinical trial portfolio
• Serve as a portfolio-level lead for external data quality and clinical-data operational strategy
• Review protocol requirements, vendor specifications, and operational data flows
• Lead all aspects of development and maintenance of Data Transfer Specification (DTS) documents to ensure compliance with Regeneron standards and timelines
• Provide expert mentorship on external data services including biomarker, eSource, eCOA, imaging, ECG, PK, genomics, and laboratory data
• Drive external vendor oversight, onboarding, qualification, governance, and ongoing performance monitoring
• Establish and handle vendor KPIs, SLAs, and quality metrics
• Govern reconciliation activities between EDC systems and vendor data platforms to ensure data integrity and consistency
• Monitor reconciliation metrics, discrepancy trends, and resolution timelines across studies
• Collaborate with Database Development, Biostatistics, Study Data Managers, and external vendors to resolve complex data discrepancies
• Lead process improvement initiatives, automation opportunities, and implementation of innovative external data solutions
• Manage and develop a team of EDAD Managers, Specialists, and associates through coaching, mentoring, and performance management
• Support SOP development, inspection readiness, audit activities, and regulatory compliance
• Represent EDAD in leadership forums, governance committees, and technology discussions

Requirements

• 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

Skills

• Strong expertise managing multiple clinical external data types including biomarker, imaging, eCOA, ECG, PK, genomics, laboratory, and Digital Health Technology data
• Advanced knowledge of external data reconciliation processes and EDC platforms such as Medidata Rave, Veeva, or Oracle Inform
• Experience working with SAS, CSV, and XML data formats
• Strong understanding of industry regulations including 21 CFR Part 11, ICH-GCP, and CDISC standards
• Proven experience handling external vendor relationships and driving accountability for quality deliverables
• Strong leadership, people management, coaching, and mentoring capabilities
• Strategic thinking, creativity, problem-solving, and analytical skills
• Strong project management and stakeholder management capabilities
• Excellent verbal and written communication skills
• Ability to work effectively in a fast-paced, matrixed, and global environment

Schedule

• Hybrid; 4 days per week on site in Warren, NJ
• 25% travel may be required

Pay

Salary Range (annually): $154,800.00 - $252,800.00

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
• Family support benefits