Summary

Regeneron Pharmaceuticals is a leading American biotechnology company founded in 1988 and headquartered in Tarrytown, New York. The company specializes in inventing, developing, and commercializing life-transforming medicines for people with serious diseases. Regeneron is renowned for its innovative antibody technologies and has developed several groundbreaking therapies, including EYLEA® for retinal diseases, DUPIXENT® for inflammatory conditions, and the COVID-19 antibody cocktail REGEN-COV®. The company operates with a strong focus on research and development across multiple therapeutic areas including ophthalmology, oncology, cardiovascular diseases, and rare genetic disorders. Regeneron's proprietary VelocImmune® technology platform enables the rapid generation of fully human monoclonal antibodies. With over 15,000 employees globally and annual revenues exceeding $14 billion, Regeneron has established itself as a major force in the biotechnology industry, consistently ranking among the top-performing pharmaceutical companies and maintaining a robust pipeline of investigational therapies.

Job description

Discover your role

Partner with Medical Directors to deliver the scientific expertise needed to design and run clinical studies
Contribute to clinical study teams, program team meetings, advisory boards, steering committees, and data/safety monitoring meetings
Support early and/or late-phase studies by helping develop protocol synopses and authoring or reviewing protocols and amendments
Author and review study documents, including medical monitoring plans, SAPs, informed consents, and clinical study report sections
Perform clinical and medical data review, including safety monitoring, to protect patient safety
Work with internal functions and external vendors to promote study integrity and consistent data review practices
Identify critical risks and recommend mitigations by analyzing how study objectives and design affect data analysis
Build and maintain deep knowledge of the disease area, mechanism of action, and drug landscape, while upholding FDA, EMA, ICH, and GCP standards

This role requires

MS/PhD/PharmD in a related field with 8+ years of pharmaceutical clinical drug development experience (other levels considered depending on experience)
Preferred: Experience in one or more of the following therapeutic areas: cardiovascular, renal, or metabolic disease
Preferred: Track record of clinical trial process improvements
Proven knowledge of the drug development process, GCP, ICH guidelines, study design, and clinical research methodology
Strong medical writing, analytical, and presentation skills, with the ability to communicate clear, concise messages
Demonstrated ability to influence within a team and cross-functionally in a matrix environment
Strong problem-solving and interpersonal skills, with the ability to resolve complex issues creatively and independently

Requirements

MS/PhD/PharmD in a related field
8+ years of pharmaceutical clinical drug development experience
Proven knowledge of the drug development process, GCP, ICH guidelines, study design, and clinical research methodology
Strong medical writing, analytical, and presentation skills
Demonstrated ability to influence within a team and cross-functionally in a matrix environment
Strong problem-solving and interpersonal skills

Benefits

Annual bonuses
Incentive plans
Equity awards
Pension or retirement benefits
401(k) company match
Health and wellness programs
Fitness centers
Insurance benefits
Paid time off
Family support benefits

Company overview

Regeneron Pharmaceuticals is a leading American biotechnology company founded in 1988 and headquartered in Tarrytown, New York. The company specializes in inventing, developing, and commercializing life-transforming medicines for people with serious diseases. Regeneron is renowned for its innovative antibody technologies and has developed several groundbreaking therapies, including EYLEA® for retinal diseases, DUPIXENT® for inflammatory conditions, and the COVID-19 antibody cocktail REGEN-COV®. The company operates with a strong focus on research and development across multiple therapeutic areas including ophthalmology, oncology, cardiovascular diseases, and rare genetic disorders. Regeneron's proprietary VelocImmune® technology platform enables the rapid generation of fully human monoclonal antibodies. With over 15,000 employees globally and annual revenues exceeding $14 billion, Regeneron has established itself as a major force in the biotechnology industry, consistently ranking among the top-performing pharmaceutical companies and maintaining a robust pipeline of investigational therapies.