Regeneron · 2 weeks ago
Associate Director, Clinical Sciences, Internal Medicine
Regeneron is a biopharmaceutical company focused on developing innovative medicines. The Associate Director, Clinical Sciences plays a pivotal role in the planning and execution of clinical studies in Internal Medicine, ensuring scientific integrity and collaboration across functions. This position involves designing and leading clinical research studies, contributing to regulatory documentation, and maintaining a deep understanding of therapeutic areas.
BiopharmaBiotechnologyPharmaceutical
Responsibilities
May function as Clinical Scientist for program, and/or as delegate of Therapeutic area Clinical Scientist
Contributes to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings; may represent function in collaborative activities with other departments
Maintains proficient understanding of therapeutic disease area(s) and drug candidate including underlying disease biology, clinical manifestations and therapeutic standard practice, compound(s) including mechanism of action and drug landscape
Utilizes proficient scientific expertise to propose, design, and execute clinical research and development studies for early and/or late-stage assets; able to conceive and communicate strategy proposals well-grounded in supporting literature
Develops the Expanded Synopsis and authors clinically relevant sections and reviews other scientific portions of clinical trial protocols and amendments. Authors and/or reviews documents related to trials, such as medical monitoring plans, SAPs, informed consents and clinical components of the Clinical Study Reports with minimal guidance and supports the development of regulatory documents; performs quality review and may approve; adjudicate and resolve cross functional comments with minimal support
Contributes to planning and prepares information for external /stakeholder meetings (IM, Governance, DMCs, Regulatory Authority); Presents data and information to external investigators (SIV) and internal collaborators
Proficient analytical knowledge and skills to understand how program objectives and design impact data analysis; Identifies risks and designs mitigation strategies
Promotes consistent first line medical/clinical data review techniques and conventions across studies/programs; Reviews clinical data review plan and authors medical monitoring plan for assigned studies/program
Qualification
Required
Bachelor's Degree required
≥ 10 years of pharmaceutical clinical drug development experience
Basic knowledge of Metabolic disease and/or inflammatory disease areas
Proficient knowledge of the drug development process
Good Clinical Practice
Study design
Clinical research methodology
Solid medical writing skills
Experience in managing trials in one or more of the following therapeutic areas - cardiovascular, renal, metabolic and/or inflammatory disease
Preferred
Advanced degree or equivalent education/degree in life science/healthcare preferred (PhD/PharmD/MSc)
Benefits
Health and wellness programs
Fitness centers
Equity awards
Annual bonuses
Paid time off for eligible employees at all levels
Company
Regeneron
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 CompanyTotal Funding
$15.93MKey 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
Recent News
2026-01-09
2026-01-08
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