Regeneron · 4 hours ago
Associate Director, Clinical Scientist, Internal Medicine (Cardio, Metabolic, & Renal)
Tarrytown, NY
Full-time
Onsite
Lead/Staff, Director/Executive
$176K/yr - $287K/yr
10+ years expRegeneron is a leading biotechnology company, and they are seeking an Associate Director Clinical Scientist to lead the development and execution of clinical studies. This role involves ensuring scientific integrity, collaborating with cross-functional teams, and contributing to candidate development projects in a matrix environment.
BiopharmaBiotechnologyPharmaceutical
Responsibilities
May function as lead Clinical Scientist for program, and/or as delegate of Therapeutic area Lead Clinical Scientist; Member of the Clinical Study Team and Global Clinical SubTeam
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
Applies proficient scientific expertise to propose, design, and complete 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
Maintains compliance in accordance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety
Leads planning and prepares information for external /stakeholder meetings (IM, Governance, DMCs, Regulatory Authority); Presents data and information to external investigators (SIV) and internal stakeholders
Performs clinical/medical data review, including safety monitoring and activities and procedures that ensure patient safety
Applies 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
May serve as a peer coach learning how to mentor and provides guidance to junior members of department and cross-functional team members as appropriate
Qualification
Required
≥ 10 years of pharmaceutical clinical drug development experience
Experience in managing clinical trials in one or more of the following therapeutic areas – cardiovascular, renal, metabolic disease
Proficient knowledge of the drug development process
Good Clinical Practice
Study design
Clinical research methodology
Solid medical writing skills
Proficient knowledge of clinical development process
Regulatory requirements
ICH/GCP guidelines
Preferred
Ability to lead activities within a matrix environment
Exhibits confidence and professional diplomacy, while effectively relating to people at all levels internally and externally
Demonstrated ability to influence within team and may influence across functionally
Demonstrates initiative, creativity and innovation skills
Directly or indirectly contributes to the development of innovations
Identifies opportunities for process improvements
Resolves novel problems requiring creative application of advanced skill, training, and education
Demonstrated leadership and accomplishment in all aspects of conducting global clinical trials and execution of clinical programs
Strong cross-functional management, interpersonal and problem-solving skills with a proven track in clinical trial process improvements
Considerable organizational awareness, including significant experience working cross-functionally
Benefits
Health and wellness programs (including medical, dental, vision, life, and disability insurance)
Fitness centers
401(k) company match
Family support benefits
Equity awards
Annual bonuses
Paid time off
Paid leaves (e.g., military and parental leave)
Company
Regeneron
Regeneron Pharmaceuticals specializes in the discovery, development, and commercialization of innovative medicines.
10001+ employees
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
Aris Baras
Senior Vice President, Regeneron Pharmaceuticals, General Manager, Regeneron Genetics Center
Bari Kowal
Senior Vice President, Head Development Operations & Portfolio Management
Recent News
Pharmaceutical Technology
2026-01-16
2026-01-16
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