Clinical Research Program Director in Cellular Therapy and Biologics for Non-Oncology Diseases (Immunology and Immunotherapy)

Mount Sinai Health System • New York, NY

9d • Onsite

About The Position

The Clinical Research Program Director will lead the operational, regulatory, financial, and strategic coordination of a clinical and translational immunology research portfolio focused on the development and clinical implementation of cellular therapies for non-oncologic diseases. This role bridges basic science, translational research, and clinical trials, with a strong emphasis on regulatory execution, including IND submissions to the FDA for both drug and cellular therapy products. The ideal candidate brings deep experience in academic clinical research environments, IND-enabling activities, and early-phase clinical trials, and is comfortable managing complex, multi-stakeholder programs involving investigators, regulatory bodies, and institutional committees.

Requirements

• Deep experience in academic clinical research environments.
• Experience with IND-enabling activities.
• Experience with early-phase clinical trials.
• Comfort managing complex, multi-stakeholder programs involving investigators, regulatory bodies, and institutional committees.

Responsibilities

• Lead the operational, regulatory, financial, and strategic coordination of a clinical and translational immunology research portfolio.
• Focus on the development and clinical implementation of cellular therapies for non-oncologic diseases.
• Bridge basic science, translational research, and clinical trials.
• Emphasize regulatory execution, including IND submissions to the FDA for both drug and cellular therapy products.
• Manage complex, multi-stakeholder programs involving investigators, regulatory bodies, and institutional committees.
• Organize a hub-and-spoke model within the Lipschultz Precision Immunology Institute at Icahn School of Medicine (PrIISM) serving as the central coordinating hub and clinical departments/divisions functioning as disease-specific spokes.

Benefits

• Strength through Unity and Inclusion
• Opportunity to help build and scale a cutting-edge translational immunology program.
• Advance cellular therapies beyond oncology into new therapeutic areas.
• Be part of Mount Sinai’s unparalleled legacy of achievement, education, and innovation.
• Work in a supportive and welcoming environment where everyone has the opportunity to thrive and advance professionally.

What This Job Offers

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