Director, External Data Acquisition and Delivery

Regeneron Pharmaceuticals; Warren (MI); Hybrid; USD 183,000 - 305,000; Full time

Job summary

Regeneron Pharmaceuticals seeks a Director of External Data Acquisition and Delivery to lead vendor oversight, data reconciliation, and transfer specifications within Clinical Data Management. You will shape how lab, biomarker, eCOA, imaging, genomics and digital health data are acquired and delivered with quality and speed.

This role requires 12+ years in clinical data and 5+ years in leadership, with expertise in ICH-GCP, 21 CFR Part 11, and major EDC platforms.

Qualifications

• Bachelor's degree in a science or data discipline with 12+ years in clinical data acquisition/management.
• Leadership experience overseeing managers or senior professionals.
• Experience leading external data vendor oversight and data transfer governance.

Responsibilities

• Set strategic direction for external data acquisition, integration, and reconciliation.
• Own portfolio governance of external data quality and risk.
• Mature the data management model including onboarding, readiness, and governance.
• Guide data transfer specifications and external data management plans.
• Set EDC-to-vendor reconciliation standards for inspection readiness and compliance.
• Advance new data capabilities and automation with Digital & Tech teams.
• Lead and develop a global team across regions.
• Represent Regeneron in industry forums and deputize for Global Head as needed.

Skills

Leadership

Vendor management

Data governance

Cross-functional collaboration

Regulatory knowledge

Project management

Education

Bachelor's degree in Science/Health/Math/Computing/Data Management

Tools

Medidata Rave

Veeva

Oracle InForm

Job description

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Director, External Data Acquisition and Delivery to join our Clinical Data Management. This role provides senior leadership for vendor and provider oversight for data and tech, external data reconciliation, data transfer specifications, external data acquisition capabilities, external data integrity, and inspection readiness across all data types. In this role, you will shape how laboratory, biomarker, eCOA, imaging, genomics, and digital health data are acquired, reconciled, and delivered with quality and speed. You will collaborate with vendors, technology teams, Quality, Procurement, and cross-functional partners while developing a high-performing across multiple regions.

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

When & where:

• Location: Warren, NJ


• Work model/flexibility: Primarily onsite with hybrid flexibility


• Travel percentage: Up to 20%

Discover your role:

• Set the strategic direction for external data acquisition, integration, and reconciliation across all therapeutic areas


• Own portfolio-level governance of external data quality, data integrity, and risk


• Own and mature the model for data management, including qualification, onboarding, operational readiness, ongoing performance monitoring, and governance for clinical data management domain in collaboration with the cross-functional team.


• Guide Data Transfer Specifications, external data management plans, and review plans with cross-functional partners


• Set EDC-to-vendor reconciliation standards that keep our processes inspection-ready and compliant with ICH-GCP and 21 CFR Part 11


• Advance new data capabilities, digital health technologies, and automation with Digital & Tech and Data Technology and Innovation


• Lead, coach, and develop a global team of Associate Directors, managers, specialists, and associates


• Represent Regeneron in industry forums such as CDISC and SCDM, and deputize for the Global Head as needed

This role requires:

• Bachelor’s degree (advanced degree preferred) in Science, Health, Mathematics, Computing, Information Systems, Data Management, or a related field with 12+ years of progressive experience in clinical data acquisition/management, external data operations.


• 5+ years of people leadership, including managing managers or senior professionals


• Experience leading external data vendor oversight, data transfer specification governance, and external data reconciliation in a regulated environment


• Advanced knowledge of ICH-GCP, 21 CFR Part 11, CDISC standards, and EDC platforms such as Medidata Rave, Veeva, or Oracle InForm


• Society of Clinical Data Management or ACRP-CP certification is recommended

Does this sound like you? 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.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or 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, and family support benefits. 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. If you have any questions, please speak with your recruiter.

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. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

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.

Salary Range (annually)

$183,100.00 - $305,200.00