Manager overseeing clinical studies in Internal Medicine, collaborating with cross-functional teams at Regeneron. Involves ensuring scientific integrity and execution of clinical studies.
Responsibilities
Assists in the development, evaluation, planning and execution of clinical studies
Ensures scientific integrity and interpretation of study data of a clinical development program
Contributes to candidate development projects through early and/or late phase development
Collaborates closely with Medical Director(s) (MDs) to provide scientific expertise necessary to design and deliver on clinical studies
Maintains compliance in accordance with FDA, EMEA, ICH and GCP guidelines
Supports clinical/medical data review, including safety monitoring and activities that ensure patient safety
Requirements
BS/MS/PhD/PharmD in a related area
≥ 6 years of pharmaceutical clinical drug development experience
Experience in one or more of the following therapeutic areas is preferred – cardiovascular, renal, metabolic disease
Basic knowledge of clinical development process, regulatory requirements and ICH/GCP guidelines
Benefits
health and wellness programs (including medical, dental, vision, life, and disability insurance)
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