Associate Director, Clinical Sciences, Internal Medicine jobs in United States
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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
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Comp. & Benefits
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H1B Sponsor Likelynote

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

Clinical drug developmentClinical research methodologyMedical writing skillsClinical PracticeStudy designCross-functional managementInnovationInfluencing skillsRisk identificationProcess improvementInterpersonal skillsAttention to detailCreativityTeam player

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

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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