Senior. Director Clinical Data Management

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 a Senior Director, Clinical Data Management - India, you will be part of the Clinical Data Management Leadership Team and plays a key role in shaping the global operational vision, strategy, and direction for Data Management in support of the clinical pipeline. This Includes the establishment of a highly performing Data Management group in the region.

The incumbent will bring deep technical and operational expertise to strengthen internal clinical data management capabilities across clinical data reporting, clinical data review, medical coding, local lab data processing and delivery, database build and testing, and external data acquisition. The focus is on improving database quality, streamlining data flow, and enabling faster, more reliable clinical insights through modern platforms, automation, and scalable processes.

This role partners closely with Clinical Data Management Central Services, Clinical Data Operations, External Data Acquisition and Delivery teams, as well as internal collaborators and external vendors, to ensure data management activities are delivered with quality, compliance, and operational efficiency from study start-up through archival across key development programs.

This position is office-based and will be on site at Regeneron’s Hyderabad office.

A typical day may include the following:

• Build and lead a strong regional Clinical Data Management organization to expand internal capabilities across clinical data reporting, data review, coding, laboratory data processing, database build and testing, and external data delivery.

• Define and supervise functional metrics, KPIs, and KQIs to supervise quality, compliance, and timely delivery.

• Be responsible for the delivery of high-quality laboratory data, coded terminology, and external data to support statistical analysis across the portfolio.

• Provide effective oversight of FSPs and external data vendors.

• Identify operational risks early and implement practical solutions to support critical study turning points globally.

• Evaluate resource needs and allocation to maintain strong productivity and delivery against functional goals.

• Shape organization design, hire top talent, and support performance and development across the team.

• Lead cross-functional initiatives that improve efficiency, strengthen operations, and support inspection readiness.

• Advance the use of automation and AI/GenAI solutions to reduce manual effort, improve data quality, and enable faster data access.

• Build strong partnerships across internal teams and external collaborators to support collaboration throughout the drug development process.

• Chip in to the development of global SOPs, WIs, BPTs, and training curricula for Clinical Data Management.

• Model company values through collaboration, innovation, accountability, respect, and sound leadership.

• Stay current on emerging trends, technologies, and standard methodologies in Clinical Data Management, and represent Regeneron in industry forums and professional associations.

This job may be for you if you have:

• Leadership experience in Clinical Data Management or a related field, including leading medium to large teams (50–150) supporting global data management functions.

• Strong expertise in clinical data management processes, industry procedures, and key clinical systems such as EDC, eSource, eCOA, IRT, Clinical Data Repositories, medical coding platforms, and laboratory normal range repositories.

• Experience assessing cases, running proof-of-concept initiatives, and scaling effective technical solutions to address operational challenges.

• Sophisticated knowledge of clinical data management principles, technologies, regulations, and standards, including 21 CFR Part 11, ICH-GCP, GxP, and GDPR.

• Strong discernment and a broad understanding of the pharmaceutical or biotech industry.

• A track record of solving complex business problems, leading transformation, and navigating change such as new operating models, acquisitions, or portfolio shifts.

• The ability to influence and build trusted relationships with senior collaborators across functions and levels.

• Success in building high-performing teams focused on innovation, transformation, and operational excellence.

• Strong communication and collaborator leadership skills.

• The ability to operate efficiently in a fast-paced environment.

• Willingness to travel up to 25%.

To be considered for this role you must have

• 15+ years of clinical data management experience in a pharmaceutical or biotech setting.

• 10+ years of functional leadership experience.

• 8+ years of people management, leadership, and mentoring experience.

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.