At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager, Clinical Sciences (Internal Medicine) to join our Clinical Sciences team, supporting our global clinical development programs in cardiovascular, renal, and metabolic disease. In this role, you will help design, execute, and interpret clinical studies, safeguarding data integrity and patient safety while collaborating with Medical Directors and cross-functional study teams. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
Location: Tarrytown, NY, Warren, NJ, Cambridge, MA
Work model/flexibility: Primarily on-site with hybrid flexibility
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
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
Tagged as: Life Sciences
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