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

Job 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

About Us

Strength through Unity and Inclusion

The Mount Sinai Health System is committed to fostering an environment where everyone can contribute to excellence. We share a common dedication to delivering outstanding patient care. When you join us, you become part of Mount Sinai's unparalleled legacy of achievement, education, and innovation as we work together to transform healthcare. We encourage all team members to actively participate in creating a culture that ensures fair access to opportunities, promotes inclusive practices, and supports the success of every individual.

At Mount Sinai, our leaders are committed to fostering a workplace where all employees feel valued, respected, and empowered to grow. We strive to create an environment where collaboration, fairness, and continuous learning drive positive change, improving the well-being of our staff, patients, and organization. Our leaders are expected to challenge outdated practices, promote a culture of respect, and work toward meaningful improvements that enhance patient care and workplace experiences. We are dedicated to building a supportive and welcoming environment where everyone has the opportunity to thrive and advance professionally. Explore this opportunity and be part of the next chapter in our history.

About the Mount Sinai Health System:

Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with more than 48,000 employees working across eight hospitals, more than 400 outpatient practices, more than 300 labs, a school of nursing, and a leading school of medicine and graduate education. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time - discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it. Through the integration of its hospitals, labs, and schools, Mount Sinai offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence and informatics while keeping patients' medical and emotional needs at the center of all treatment. The Health System includes more than 9,000 primary and specialty care physicians; 13 joint-venture outpatient surgery centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers. We are consistently ranked by U.S. News & World Report's Best Hospitals, receiving high "Honor Roll" status, and are highly ranked: No. 1 in Geriatrics, top 5 in Cardiology/Heart Surgery, and top 20 in Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 12 in Ophthalmology. U.S. News & World Report's "Best Children's Hospitals" ranks Mount Sinai Kravis Children's Hospital among the country's best in several pediatric specialties. The Icahn School of Medicine at Mount Sinai is ranked No. 11 nationwide in National Institutes of Health funding and in the 99th percentile in research dollars per investigator according to the Association of American Medical Colleges. Newsweek's "The World's Best Smart Hospitals" ranks The Mount Sinai Hospital as No. 1 in New York and in the top five globally, and Mount Sinai Morningside in the top 20 globally.

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.