Associate Director, External Clinical Data Management jobs in United States
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Regeneron · 1 week ago

Associate Director, External Clinical Data Management

Regeneron is a biopharmaceutical company that focuses on the development of medicines for serious diseases. The Associate Director, External Data Services will oversee the External Data Services team, ensuring compliance with industry standards and Regeneron procedures while driving strategic initiatives and managing vendor relationships.

BiopharmaBiotechnologyPharmaceutical
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Shape and implement the strategy for External Data Services
Lead and manage a team of External Data Services Managers and Specialists
Oversee the development and maintenance of all DTS documents, ensuring alignment with Regeneron standards, processes, and timelines
Drive the External Data Vendor Oversight model, establishing effective communication, partnership-level processes, and portfolio-level transparency on DTS status and escalations
Represent External Data Services in leadership forums and technology discussions
Contribute to and execute the External Data Services technology strategy
Provide expert-level guidance to CROs, stakeholders, and external vendors on External Data Services
Identify process gaps and lead initiatives to improve processes
Track milestones and deliverables, escalate issues, and communicate portfolio-level updates to stakeholders
Lead or contribute to special projects requiring strategic input and expertise in External Data
Serve as a subject matter expert (SME) for complex topics requiring leadership-level commitment
Develop SOPs, Work Instructions, Guidance Manuals, and other DTS development tools
Provide coaching, mentoring, and performance management for direct reports
Manage resource allocation and planning for External Data Services

Qualification

External Clinical Data ManagementData Management expertiseSASCSVXML extraction21 CFR Part 11 knowledgeICH-GCP Guidelines knowledgeCDISC standards knowledgeImaging Data experienceBiomarker data knowledgeAnalytical skillsLeadership skillsProblem-solving skillsProject management skillsInterpersonal skillsCommunication skillsAttention to detail

Required

A minimum of 10+ years of experience in External Clinical Data Management, with expert knowledge of database structures in biotechnology, pharmaceutical, or health-related industries
At least 4 years of people management experience
A Bachelor's degree in Science, Health, Computing, or a related field
Hands-on experience with Imaging Data is required

Preferred

Advanced knowledge of Biomarker data types and/or Imaging Data for oncology and non-oncology studies is a plus
Expert knowledge of database structures is preferred

Benefits

Health and wellness programs
Fitness centers
Equity awards
Annual bonuses
Paid time off for eligible employees at all levels

Company

Regeneron

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Regeneron Pharmaceuticals specializes in the discovery, development, and commercialization of innovative medicines.

H1B Sponsorship

Regeneron has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (157)
2024 (128)
2023 (128)
2022 (137)
2021 (104)
2020 (122)

Funding

Current Stage
Public Company
Total Funding
$15.93M
Key Investors
U.S. Department of Health & Human Services
2024-07-11Post Ipo Equity· $2.03M
2023-10-18Post Ipo Equity· $5M
2016-08-22Post Ipo Equity· $8.9M

Leadership Team

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Aris Baras
Senior Vice President, Regeneron Pharmaceuticals, General Manager, Regeneron Genetics Center
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Bari Kowal
Senior Vice President, Head Development Operations & Portfolio Management
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Company data provided by crunchbase