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

Benefits

Qualifications

• •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
• •Bachelor’s degree required
• •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
• •4 more items(s)

Responsibilities

• •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
• •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
• •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
• •21 more items(s)