Description d’emploi
Job Description
About Regeneron
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.
This position is office-based and will be on site at Regeneron’s Hyderabad office.
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 have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.