Associate Director, External Data Acquisition and Delivery

Regeneron Pharmaceuticals • Warren, MI

19d • Hybrid

About The Position

Regeneron is seeking an Associate Director to join its Clinical Data Management team. This role provides strategic oversight and operational leadership for External Data Acquisition and Delivery (EDAD) activities across the clinical trial portfolio. The Associate Director ensures readiness of external data collection platforms, data conformance tools, and reconciliation processes, and oversees delivery of high-quality, compliant external data from third-party vendors. Data types include laboratory, biomarker, Digital Health Technologies, imaging, ECG, PK, genomics, and specialty data.

The role partners with Clinical Data Management, CROs, external vendors, and cross-functional stakeholders to advance external data strategy, operational excellence, vendor oversight, digital transformation, and process improvement. It leads portfolio-level external data quality and operational strategy, manages and develops EDAD staff, and represents EDAD in leadership forums, governance committees, and technology discussions.

The position is based in Warren, New Jersey, with a hybrid schedule requiring four days per week onsite. Travel may be required, up to 25%.

Requirements

• At least 10 years of experience in Clinical Data Acquisition or Management within biotechnology, pharmaceutical, or healthcare industries.
• At least 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.
• 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 managing 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.

Nice To Haves

• Advanced degree.

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 development and maintenance of Data Transfer Specification (DTS) documents, ensuring 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 manage 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.

Benefits

• Annual bonuses or other incentive plans (depending on country and role).
• Equity awards (depending on country and role).
• Pension or retirement benefits (depending on country and role).
• 401(k) company match (depending on country and role).
• Health and wellness programs (depending on country and role).
• Fitness centers (depending on country and role).
• Insurance benefits, including medical, dental, vision, life, and disability (depending on country and role).
• Paid time off (depending on country and role).
• Family support benefits (depending on country and role).

What This Job Offers

• Job Type: Full-time
• Career Level: Director