Job DescriptionThe 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.
ResponsibilitiesProgram & 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.
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)
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
