We are seeking a Clinical Trials and Regulatory Affairs Manager for an exciting opportunity to help launch and establish the Center for Psychedelic Psychotherapy and Trauma Research (the Center) at the Icahn School of Medicine at Mount Sinai in collaboration with its affiliate, the James J. Peters Veterans Affairs Medical Center in the Bronx (Bronx VA). The incumbent will also work on other clinical studies of Post-traumatic Stress Disorder (PTSD)through the Traumatic Stress Studies Division, including a study designed to prevent the development of PTSD. The Center will provide novel clinical treatments with MDMA, psilocybin and other psychedelics through FDA-approved research protocols. The mission of the Center is to perform rigorous clinical trials on existing and novel psychedelic-assisted psychotherapies in trauma survivors, and to apply state-of-the art scientific methods to understand their mechanism of action. The Center seeks to provide education and training to therapists, medical residents, and trainees to position them to work with these therapies. The incumbent will be an integral member of the research and leadership team and will be responsible for programmatic support of all clinical trials as well as various existing project within Dr. Yehuda’s laboratory.

Responsibilities

• Plan and oversee regulatory activities for development of psychedelic assisted psychotherapy and other clinical trials; provide expertise and strategy
• Based on deep understanding of clinical trial operations and management of clinical trials, you will be responsible for preparation of study protocols, case report forms, patient consent forms, study monitoring procedures, internal review board submission documents, clinical study reports, case study reports as well as study site contracts for FDA regulatory trials, investigator-initiated trials and pharma partner trial projects.
• Manage the regulatory submission process and interactions with regulatory agencies such as FDA, DEA, and local IRBs. This includes maintaining continuing approvals from various committees and organizations (In-house: Scientific Committee, Institutional Review Board, Biosafety Committee)
• Ensure compliance with GCP, and regulatory guidelines
• Standardize all Center operations and establish clear, documented protocols
• Submission of study amendments in a timely fashion including changes to the protocol, consent forms and other study documents
• Prepare for and facilitate internal and third-party audits as necessary
• Supervise research coordinators on all aspects of regulatory documentation and submission. Important skills:
• Attention to detail
• Excellent oral and written communication skills
• Well organized with project and time management skills.; ability to plan and coordinate many moving pieces to achieve results, especially the development of new projects.
• Ability to work as a member of a team
• Expertise in clinical trials required; experience with medical and/or psychiatric research, and academic settings, a plus.
• Sense of mission Experience:

Qualifications

• Bachelor's degree in Nursing, Biology, and Public Health or related scientific/health field, Masters preferred.
• 6+ years of experience managing clinical trials, including 2 years in a management/leadership role
• Working with a sponsor company (biotech/pharmaceutical company), ideally in hospital setting ? Working knowledge of FDA and other government regulations required ? Knowledge of MS Office suites

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.