Director, Clinical Data Management

Regeneron Pharmaceuticals, Inc (USA); Cambridge (MA); Hybrid; USD 183,000 - 305,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc (USA) is seeking a Director of Clinical Data Management to lead and shape data management strategy, ensure high-quality, inspection-ready data, and mentor a team of managers and data managers. The role sits within a hybrid work model and collaborates with cross-functional partners and vendors.

Responsibilities include guiding portfolio execution, setting goals, and ensuring quality across studies, while maintaining strong relationships with leadership and sponsors.

Qualifications

• 12+ years of clinical data management experience in biotechnology, pharmaceutical, or health-related industries.
• 5+ years of people management experience.
• Bachelor's degree in Mathematics, Science, or related field and CCDM certification.
• Expert knowledge of 21 CFR Part 11, ICH-GCP, and CDISC standards.
• Proven record of leading studies and study teams, and motivating virtual teams in a matrix environment.

Responsibilities

• Lead, coach, and mentor managers and data managers, providing performance feedback and growth opportunities.
• Oversee portfolio-level execution, tracking milestones and deliverables, and resolving risks and critical issues.
• Partner with senior leadership to shape department goals, organizational structure, and resource allocation.
• Hold CROs and vendors accountable for quality and compliance, and help build long-term outsourcing partnerships.
• Drive inspection and audit readiness, overseeing the team through inspections and quality gap resolution.
• Sponsor or lead cross-functional initiatives and represent Data Management in program and leadership forums.

Skills

Leadership

Project management

Communication

Strategic thinking

Mentoring

Education

Bachelor's degree in Mathematics/Science or related field

Certified Clinical Data Manager (CCDM)

Tools

21 CFR Part 11

ICH-GCP

CDISC standards

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, Clinical Data Management to join our Data Management organization, serving as Therapeutic Area Head in a hybrid work model. In this role, you will set the data management vision and strategy for one or more therapeutic areas, ensure high-quality, inspection-ready clinical data, and coach and develop a team of managers and data managers. You will collaborate closely with cross-functional partners, CROs, and outsourcing vendors. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & Where:

• Location: Cambridge, MA; Warren, NJ; Armonk, NY
• Work model: mostly onsite with hybrid flexibility

Discover your role:

• Lead, coach, and mentor managers and data managers, providing performance feedback and growth opportunities
• Oversee portfolio-level execution, tracking milestones and deliverables, and resolving risks and critical issues
• Partner with senior leadership to shape department goals, organizational structure, and resource allocation
• Hold CROs and vendors accountable for quality and compliance, and help build long-term outsourcing partnerships
• Drive inspection and audit readiness, overseeing the team through inspections and quality gap resolution
• Build strong relationships across teams by negotiating effectively, managing conflict, and collaborating
• Sponsor or lead cross-functional initiatives and represent Data Management in program and leadership forums

This role requires:

• Bachelor's degree in Mathematics, Science, or a related field, plus a Certified Clinical Data Manager (CCDM) certification
• 12+ years of clinical data management experience in biotechnology, pharmaceutical, or a health-related industry
• 5+ years of people management experience
• Expert knowledge of 21 CFR Part 11, ICH-GCP, and CDISC standards
• Proven record of leading studies and study teams, and of motivating virtual teams in a matrix environment
• Strong problem-solving, project management, and communication skills, with a strategic approach and the ability to thrive in a fast-paced 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.

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.

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

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician‑scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA‑approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.