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

The Clinical Research Program Directorwill 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.

• Bachelors degree required. Masters 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