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

Responsibilities

• 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
• Support design, startup, and execution of early-phase (Phase I/II) clinical trials involving cellular therapies for non-cancer indications
• Interface with clinical operations teams to ensure protocol adherence, subject safety, and data compliance/integrity
• 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
• 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
• Collaborate with 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

Qualifications

• 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)