Associate Director Clinical Data Management Program Lead

Regeneron Pharmaceuticals; Cambridge (MA); Hybrid; USD 157,000 - 257,000; Full time

Job summary

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

The role requires a bachelor’s degree and 10+ years in CDM with 5+ years in people leadership, plus strong knowledge of 21 CFR Part 11, ICH-GCP, and CDISC.

Qualifications

• 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.

Responsibilities

• 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.

Skills

CCDM certification

Project management

Communication skills

Problem solving

Education

Bachelor’s degree in Mathematics, Science, or a related field

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 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 requires

• 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 jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$157,200.00 - $256,600.00

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.