Associate Director, Clinical Scientist, Cardiovascular/Metabolic disease

Regeneron Pharmaceuticals • Warren, MI

9d • Hybrid

About The Position

Regeneron is seeking an Associate Director, Clinical Sciences (Internal Medicine) to join its Clinical Sciences team and support global clinical development programs in cardiovascular, renal, and metabolic disease. The role leads the design, execution, and scientific interpretation of clinical studies, ensuring data integrity and patient safety while partnering closely with Medical Directors and cross-functional teams. It offers the opportunity to contribute to a science-driven organization developing medicines for people with serious diseases.

The position is based in Tarrytown, New York; Warren, New Jersey; or Cambridge, Massachusetts. It is primarily on-site, with hybrid flexibility. The role involves leading clinical studies and programs in a matrix environment, serving as lead Clinical Scientist or delegate for the therapeutic area, and working with Medical Directors to provide scientific expertise for early- and/or late-phase studies. Responsibilities also include preparing and reviewing study documents, proposing evidence-based strategies, presenting data and plans to stakeholders, conducting clinical and medical data review, promoting patient safety and regulatory compliance, addressing risks, and mentoring colleagues.

Requirements

• MS, PhD, or PharmD in a related field.
• 10 or more years of pharmaceutical clinical drug development experience; other levels may be considered depending on experience.
• Experience managing clinical trials in one or more of 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 and the ability to communicate clear, concise messages and present with confidence.
• Demonstrated leadership in conducting global clinical trials and executing clinical programs.
• 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 provide scientific expertise for designing and completing early- and/or late-phase studies.
• Develop expanded synopses and author or review protocols, amendments, medical monitoring plans, statistical analysis plans (SAPs), informed consents, and clinical study report sections.
• Propose and communicate study strategies grounded in supporting literature and knowledge of the disease area, mechanism of action, and drug landscape.
• Present data and plans to investigators, governance bodies, data monitoring committees (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 and uphold 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.

Benefits

• Competitive and comprehensive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits, paid time off, and family support benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Director