Senior Manager, Clinical Sciences – Internal Medicine

Regulatory Jobs; Village of Tarrytown (NY); On-site; USD 151,000 - 246,000; Full time

Job summary

Regeneron seeks a Senior Manager, Clinical Sciences (Internal Medicine) to lead the scientific design and execution of cardiovascular, renal, and metabolic studies. You will collaborate with Medical Directors and cross-functional teams to ensure high data integrity and patient safety across global programs.

The role emphasizes protocol development, medical writing, and safety monitoring, with on-site work in Tarrytown, NY and surrounding locations.

Qualifications

• MD/PhD/PharmD or equivalent in a related field with 8+ years of pharmaceutical clinical drug development experience
• Experience in cardiovascular, renal, or metabolic diseases preferred
• Strong knowledge of GCP, ICH guidelines, trial design, and clinical research methodology

Responsibilities

• Partner with Medical Directors to design and run clinical studies
• Contribute to clinical study teams, program meetings, advisory boards, and data/safety monitoring meetings
• Support early and/or late-phase studies by developing protocol synopses and drafting or reviewing protocols and amendments
• Author and review study documents including monitoring plans, SAPs, informed consents, and clinical study report sections
• Perform clinical and medical data review, including safety monitoring to protect patient safety
• Collaborate with internal functions and external vendors to promote study integrity
• Identify risks and mitigations by analyzing how study objectives and design affect data analysis
• Build deep knowledge of disease areas, MOA, and drug landscape while upholding FDA/EMA/ICH/GCP standards

Skills

Clinical trial design

Medical writing

Data analysis

Cross-functional teamwork

Regulatory knowledge

Education

MS/PhD/PharmD in related field

Job description

Regeneron seeks a Senior Manager, Clinical Sciences (Internal Medicine) to lead the scientific design and execution of cardiovascular, renal, and metabolic studies. You will collaborate with Medical Directors and cross-functional teams to ensure high data integrity and patient safety across global programs.

The role emphasizes protocol development, medical writing, and safety monitoring, with on-site work in Tarrytown, NY and surrounding locations.