Associate Director, Clinical Sciences: Cardio/Metabolic

Regeneron Pharmaceuticals, Inc.; Warren (MI); On-site; USD 176,000 - 287,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking an Associate Director, Clinical Sciences (Internal Medicine) to lead the design, execution and scientific interpretation of cardiovascular, renal, and metabolic studies, ensuring data integrity and patient safety.

In a matrix environment, you will partner with Medical Directors to draft protocols and monitoring plans, present data to investigators and governing bodies, and mentor junior team members to advance global programs across late- and

Qualifications

• MS/PhD/PharmD in a related field with 10+ years of pharmaceutical clinical drug development experience
• Experience managing clinical trials in cardiovascular, renal, or metabolic disease
• Proficient knowledge of the drug development process, GCP, ICH guidelines, study design, and clinical research methodology
• Solid medical writing skills, with the ability to communicate clear, concise messages and present with confidence
• Demonstrated leadership in conducting global clinical trials and executing clinical programs
• Proven ability to influence cross-functionally, resolve novel problems creatively, and drive clinical trial process improvements

Responsibilities

• Lead clinical studies and programs in a matrix environment, serving as lead Clinical Scientist or delegate for the therapeutic area
• Partner with Medical Directors to deliver the scientific expertise needed to design and complete early and/or late-phase studies
• Develop expanded synopses and author or review protocols, amendments, medical monitoring plans, SAPs, informed consents, and clinical study report sections
• Propose and communicate study strategies grounded in the supporting literature and a deep understanding of the disease area, mechanism of action, and drug landscape
• Present data and plans to investigators, governance bodies, DMCs, and regulatory authorities, and contribute to advisory boards and steering committees
• Perform clinical and medical data review, including safety monitoring, to protect patient safety while upholding FDA, EMA, ICH, and GCP standards
• Identify risks, design mitigation strategies, and promote consistent data review practices across studies and programs
• Mentor and coach junior team members and cross-functional colleagues

Skills

Clinical study leadership

Cross-functional collaboration

Medical writing

Regulatory knowledge

Data interpretation

Education

MS/PhD/PharmD in a related field

Job description

Regeneron Pharmaceuticals, Inc. is seeking an Associate Director, Clinical Sciences (Internal Medicine) to lead the design, execution and scientific interpretation of cardiovascular, renal, and metabolic studies, ensuring data integrity and patient safety.

In a matrix environment, you will partner with Medical Directors to draft protocols and monitoring plans, present data to investigators and governing bodies, and mentor junior team members to advance global programs across late- and