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

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.

 

Why Join Us

This is a unique opportunity to help build and scale a cutting-edge translational immunology program advancing cellular therapies beyond oncology into new therapeutic areas. The Clinical Research Program Director will 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.

Program & Portfolio Management

• Oversee day-to-day management of translational research programs in immunology and cellular therapy
• Coordinate cross-functional teams including faculty, clinical research staff, GMP facilities, regulatory affairs, and external collaborators
• Develop and manage project timelines, milestones, budgets, and deliverables across preclinical and clinical phases
• Track progress of multiple concurrent studies and ensure alignment with institutional and sponsor priorities

Clinical Trials & Translational Research

• Support design, startup, and execution of early-phase (Phase I/II) clinical trials involving cellular therapies for non-cancer indications
• Coordinate activities spanning pre-clinical development, IND-enabling studies, and clinical implementation
• Interface with clinical operations teams to ensure protocol adherence, subject safety, and data compliance/ integrity

Regulatory Strategy & IND Submissions

• Lead preparation, coordination, and submission of Investigational New Drug (IND) applications to the FDA, including for cell and gene therapy products
• Manage regulatory documentation (e.g., protocols, investigator brochures, CMC sections, pharmacology/toxicology data)
• Serve as liaison with FDA and support responses to information requests, clinical holds, and annual reports
• Ensure compliance with GCP, GMP, and applicable regulatory requirements

Operational & Institutional Navigation

• Guide studies through internal review processes (e.g., IRB, biosafety, data use, and institutional committees)
• Coordinate with technology transfer, legal, and compliance offices as needed
• Establish and refine workflows to streamline translational research operations within the department

Collaboration & Communication

• Serve as a central point of coordination between investigators, institutional leadership, sponsors, and external partners
• Prepare reports, presentations, and updates for internal stakeholders and funding agencies
• Facilitate multidisciplinary meetings and ensure clear communication across teams
• Performs other related duties.

• Bachelor?s degree required. Master?s degree in life sciences, public health, regulatory science, or a related field strongly preferred. Advanced clinical or doctoral degrees (PhD, MD, RN, or equivalent) are also strongly preferred.
• Minimum of 7 years of experience in a hospital or medical environment, preferably within human subjects or clinical trials research, including at least 3 years of supervisory experience.
• Demonstrated experience managing clinical trials, particularly early-phase or investigator-initiated studies
• Direct experience preparing and submitting IND applications to the FDA, including cellular therapy and/or biologic products

• Experience in translational medicine, ideally in immunology or cell therapy (non-oncology focus preferred)

   

Skills & Knowledge

• Strong understanding of FDA regulatory pathways, especially IND requirements for drugs and cell-based therapies
• Familiarity with GCP, GMP, and IND-enabling preclinical requirements
• Proven ability to manage complex, multidisciplinary programs and timelines
• Excellent organizational, communication, and stakeholder management skills

• Ability to navigate academic institutional processes and regulatory committees