仕事内容
Regeneron is founded on the belief that the right idea, combined with the right team, can lead to significant transformations. Our growing global network is dedicated to inventing, developing, and commercializing medicines that change lives for those with serious diseases. In doing so, we are pioneering innovative approaches to science, manufacturing, and commercialization, as well as redefining our understanding of health.
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.
A Typical Day May Include:
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 May Be For You If You Have:
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
To Be Considered For This Role, You Must Have:
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
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! 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)
$157,200.00 - $256,600.00