Director, Clinical Data Management

Regeneron; Cambridge (MA); Hybride; USD 183 000 - 305 000; Plein temps

Avantages offerts par ce poste

Hybrid work model

Résumé du poste

Regeneron Pharmaceuticals, Inc. in Cambridge, MA is hiring a Director of Clinical Data Management to lead the Data Management organization and set vision for therapeutic data management. The role is hybrid with onsite expectations across Cambridge, MA; Warren, NJ; and Armonk, NY.

You will coach managers and data managers, oversee portfolio milestones, shape department goals, and ensure high-quality, inspection-ready data while partnering with CROs and outsourcing vendors.

Qualifications

• Bachelor's degree in Mathematics, Science, or related field; CCDM certification.
• 12+ years of clinical data management experience in biotech/pharma or 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 virtual teams in a matrix environment.
• Strong problem-solving, project management, and communication skills with a strategic approach.

Responsabilités

• 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.

Connaissances

Leadership

People management

Communication

Strategic thinking

Problem solving

Formation

Bachelor's degree in Math/Science

CCDM certification

Description du poste

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

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