Associate Director Clinical Data Management Program Lead

Regeneron; New Jersey; Hybrid; USD 180,000 - 235,000; Full time

Benefits offered by this job

Medical, dental and vision insurance

Life insurance and disability coverage

Global wellness support

Paid time off

Job summary

Regeneron Pharmaceuticals, Inc. seeks an Associate Director, Clinical Data Management, Program Lead to steer CDM activities across clinical programs. You will partner with senior leadership, study teams, and external partners to ensure quality, timelines, and budgets are met.

The role focuses on strategy, governance, and mentorship in a fast-growing environment and offers on-site with hybrid flexibility across Warren, NJ or nearby locations.

Qualifications

• 10+ years in clinical data management in biotech/pharma.
• 5+ years of people management experience.
• Strong knowledge of 21 CFR Part 11, ICH-GCP, and CDISC standards.
• Proven record leading studies and virtual teams.

Responsibilities

• Lead the overall success of CDM deliverables across studies and programs.
• Communicate program status, risks, and issues to collaborators and develop mitigations.
• Provide CDM expertise during protocol design, study start-up, and study conduct with standardized practices.
• Oversee program timelines, resources, and budgets, serving as escalation point for issues.
• Track metrics and KPIs, manage Quality Events, CAPAs, and deviations.
• Represent CDM in reviews, CRO governance, and joint meetings with collaborators.
• Drive inspection readiness and coordinate CDM activities during regulatory inspections.
• Mentor and coach team members, and manage staff development and performance.

Skills

CDM leadership

Cross-functional leadership

Regulatory knowledge

Project management

Communication skills

Education

Bachelor's degree in Mathematics, Science, or related field

Job description

Associate Director Clinical Data Management Program Lead

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Associate Director, Clinical Data Management, Program Lead to lead the strategic management of CDM activities across assigned clinical programs, ensuring quality, timelines, and budgets are met while collaborating with senior leadership, clinical study teams, external vendors, and collaboration partners.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

• Location: Warren, NJ, Armonk, NY or Tarrytown, NY
• Work model/flexibility: mostly onsite with hybrid flexibility

Discover your role:

• Lead the overall success of CDM deliverables across studies and programs
• Communicate program status, risks, and issues proactively to collaborators and develop mitigation strategies
• Provide CDM expertise during protocol design, study start‑up, and study conduct, promoting consistent standards and best practices
• Oversee program timelines, resources, and budgets, and serve as the escalation point for program and study issues
• Track metrics and KPIs, and manage Quality Events, CAPAs, and process deviations
• Represent CDM in review committees, CRO governance, and joint meetings with collaborators
• Drive inspection readiness and coordinate CDM activities during regulatory inspections
• Mentor and coach team members, and, where applicable, manage staff through recruitment, development, and performance management

This role require s:

• Bachelor's degree in Mathematics, Science, or a related field
• 10+ years of clinical data management experience in the biotechnology, pharmaceutical, or health-related industry and 5+ years of people management experience
• Solid understanding of 21 CFR Part 11, ICH‑GCP guidelines, and CDISC standards for data collection
• Proven record of leading studies and study teams, with the ability to motivate virtual teams in a matrix environment
• Strong problem‑solving, project management, and communication skills in a fast‑paced setting
• Certified Clinical Data Manager (CCDM) certification is preferred

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.

• Location: Cambridge, United States of America, Armonk, United States of America and 1 other locations
• Location: Remote - United States of America
• Location: Remote - United States of America

We take hiring seriously — because finding the right person for our mission matters as much to us as finding the right company matters to you. Our process is thorough by design: we want every new hire to feel confident they've found a place where their work truly matters, and we want to be just as confident we've found someone who'll thrive here. It's a two‑way conversation, not a one‑way interview.

Curious what that looks like step by step? Check out How We Hire.

Part of the team

Where You'll Make an Impact

Here, you’ll collaborate with teams across regions to help move our mission forward.

We invest in your health and stability so you can focus on making meaningful impact. Below is a highlight of benefit programs that may be available to you, depending on your country of employment, role, etc.

• Medical, dental and vision insurance
• Life insurance and disability coverage
• Global wellness support & benefits access
• Paid time off, personal/flexibility hours and holiday leave

How We Hire

From application to your first day — here's how it works.

1. EXPLORE

Browse open roles at careers.regeneron.com, filtered by department, location or category. You can also create a job alert or join our Talent Community to get matched with new openings as they post.

2. APPLY

See something you like? Submit your application for the role that fits your background and goals.

3. CONNECT

We review your application and if your experience is a match, we'll reach out to start the conversation. Some roles include a seminar or technical exercise — we'll always tell you in advance.

4. DECISION

After interviews and careful consideration by the hiring team, we'll follow up either way. If you're selected, we'll walk you through the offer — compensation, benefits, and start date.

5. WELCOME

Once you accept, we'll help you prepare for day one - from paperwork and office details to relocation when applicable. You'll have the support you need to start strong.

Stay connected

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