Clinical Trials Manager-Center for Psychedelic Psychotherapy and Trauma Research

Overview We are seeking a Clinical Trials and Regulatory Affairs Manager 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 partnership with the James J. Peters Veterans Affairs Medical Center in the Bronx (Bronx VA). The incumbent will also work on clinical studies of Post‑traumatic Stress Disorder (PTSD) through the Traumatic Stress Studies Division, including a study to prevent the development of PTSD. The Center will provide novel clinical treatments with MDMA, psilocybin, and other psychedelics through FDA‑approved research protocols. Its mission 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 also seeks to provide education and training to therapists, medical residents, and trainees to prepare 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 and various existing projects within Dr. Yehuda’s laboratory. Responsibilities Plan and oversee regulatory activities for development of psychedelic‑assisted psychotherapy and other clinical trials, providing expertise and strategy. Prepare study protocols, case record forms, patient consent forms, study monitoring procedures, IRB submission documents, clinical study reports, case study reports, and 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, maintaining continuing approvals from committees and organizations (Scientific Committee, Institutional Review Board, Biosafety Committee). Ensure compliance with GCP and regulatory guidelines. Standardize all Center operations and establish clear, documented protocols. Submit study amendments in a timely manner 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. 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. Qualifications Bachelor’s degree in Nursing, Biology, Public Health, or related scientific/health field; Master’s preferred. 6+ years of experience managing clinical trials, including 2 years in a management/leadership role. Experience working with a sponsor company (biotech/pharmaceutical company), ideally in a hospital setting. Working knowledge of FDA and other government regulations. Knowledge of MS Office suites. Equal Opportunity Employer 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 everyone feels respected and supported. Compensation The salary range for this role is $104,995 – $157,492 annually, depending on experience, education, and operational need. The range does not include bonuses, incentive pay, differential pay, or other forms of compensation or benefits. #J-18808-Ljbffr