Associate Director, External Data Acquisition and Delivery

Regeneron Pharmaceuticals; Warren (MI); Híbrido; USD 155.000 - 253.000; Jornada completa

Descripción de la vacante

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,

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Clinical Data Management

Vendor Oversight

Leadership

Data Reconciliation

Project Management

Educación

Bachelor’s degree in Science/Health/Computing

Advanced degree preferred

Herramientas

Medidata Rave

Veeva

Oracle Inform

SAS

CSV

XML

Descripción del empleo

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Associate Director to join our Clinical Data Management team.

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.

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

When & where:

• Work Location: Warren, NJ

• Hybrid; 4 days per week on site

• 25% Travel may be required

Discover your role:

• 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

This role requires:

• Minimum 10+ years of experience in ClinicalDataAcquisition/Managementwithinbiotechnology, 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

• 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

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.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

Salary Range (annually)

$154,800.00 - $252,800.00