Clinical Research Program Director in Cellular Therapy and Biologics for Non-Oncology Diseases [...]

Description 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. Responsibilities 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. 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 Equal Opportunity Employer The Mount Sinai Health System is an equal opportunity employer, complying with all applicable federal civil rights laws. We do not discriminate, exclude, or treat individuals differently based on race, color, national origin, age, religion, disability, sex, sexual orientation, gender, veteran status, or any other characteristic protected by law. We are deeply committed to fostering an environment where all faculty, staff, students, trainees, patients, visitors, and the communities we serve feel respected and supported. Our goal is to create a healthcare and learning institution that actively works to remove barriers, address challenges, and promote fairness in all aspects of our organization. Compensation The Mount Sinai Health System (MSHS) provides salary ranges that comply with the New York City Law on Salary Transparency in Job Advertisements. The salary range for the role is $115,494 - $194,020.12 Annually. Actual salaries depend on a variety of factors, including experience, education, and operational need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits. #J-18808-Ljbffr Mount Sinai Medical Center