Associate Director Clinical Data Management Program Lead

Regeneron Pharmaceuticals, Inc (USA); Kentucky; Hybrid; USD 157,000 - 257,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

Pension or retirement benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits

Paid time off

Family support benefits

Job summary

Regeneron Pharmaceuticals, Inc. is seeking an Associate Director, Clinical Data Management, Program Lead to oversee CDM activities across clinical programs.

The role partners with senior leadership, study teams, vendors, and collaborators to ensure quality, timelines, and budgets are met while advancing data standards. The position requires a Bachelor's in a related field and 10+ years of CDM experience with 5+ years in people management.

Qualifications

• Bachelor's degree in Mathematics, Science, or related field.
• 10+ years of clinical data management experience in biotech/pharma/health industry.
• 5+ years of people management experience.
• Solid understanding of 21 CFR Part 11, ICH-GCP, and CDISC standards.

Responsibilities

• Lead the overall success of CDM deliverables across studies and programs.
• Communicate program status, risks, and issues to collaborators and develop mitigation strategies.
• Provide CDM expertise during protocol design, startup, and conduct, promoting standards.

Skills

CDM leadership

Program management

Communication

Metrics & KPIs

Problem solving

CCDM preferred

Education

Bachelor's degree in Mathematics/Science/related field

Tools

CDISC standards

21 CFR Part 11

ICH-GCP guidelines

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.

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.

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)

$157,200.00 - $256,600.00

Benefits

• 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
• family support benefits

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.