Job Description

The Director of Regulatory & Administrative Affairs for the Mount Sinai Institute for Transformative Clinical Trials provides strategic leadership and operational oversight for regulatory, safety, and administrative activities supporting a portfolio of sponsor-led, investigator-initiated, federally funded, and industry-sponsored clinical research studies.

Serving within an Academic CRO and Data and Clinical Coordinating Center environment, this position is responsible for regulatory oversight of domestic and international multicenter clinical trials conducted across participating research institutions. The Director provides leadership for regulatory affairs and safety operations activities across the study lifecycle, and ongoing support of participating sites within multicenter clinical research networks.

The ideal candidate will have demonstrated experience with FDA and Health Canada submissions, including Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications, Institutional Review Board (IRB) submissions (sIRB and local IRB), and regulatory oversight of multi-center human subjects research.

Regulatory & Compliance

• Provide strategic leadership including development and oversight of regulatory activities supporting multicenter clinical trials

• Ensure sponsor and multi-center site compliance with FDA regulations, ICH-GCP guidelines, human subjects protection requirements, institutional policies, sponsor obligations, and applicable international regulatory requirements including Canada, the United Kingdom, and the European Union for IND, IDE, and non-FDA regulated clinical trials

• Ensure compliance with applicable international privacy and data protection requirements, including GDPR and related regulations

• Develop and implement regulatory policies, procedures, and operational processes that support compliant and efficient research operations including creation of regulatory document and binder templates, Manuals of Procedures (MOPs) and SOPs

• Prepare and submit new study applications (IND/IDE), amendments, continuing reviews, reportable safety events, and study closures to the FDA, HC, and Institutional Review Boards

• Monitor regulatory deadlines and reporting requirements to ensure ongoing compliance at both the DCC/CCC and study site level

• Develop and maintain regulatory binders (including oversight of study site regulatory binders) and essential study documents including Trial Master File (eTMF)

• Create and review informed consent document templates and recruitment materials for regulatory compliance and consistency with protocol requirements

• Track protocol amendments, investigator qualifications, training records, and regulatory approvals for the DCC/CCC and the study staff at participating sites

• Support study start-up, staff and study team training, site activation, audits, and inspections

• Assist with responses to regulatory findings, audit observations, and corrective and preventive action (CAPA) plans when needed

• Ensure ongoing readiness for sponsor audits, quality assurance reviews, and regulatory inspections

• Direct, train, and mentor regulatory, safety, and administrative personnel

Safety Operations & Oversight Committees

• Provide leadership and oversight for clinical trial safety operations, including expedited safety reporting, and other regulatory safety requirements for IND/IDE/non-FDA regulated clinical trials

• Oversee safety desk operations and ensure timely communication of safety information to investigators, sponsors, IRBs, DSMBs, regulatory authorities, and participating sites

• Oversee operational and regulatory support for Data and Safety Monitoring Boards (DSMBs), Clinical Event Adjudication Committees (CEC/EACs), Independent Medical Monitors, and other required parties

• Bachelors Degree in Administration, or related field Masters preferred
• 7 years experience in administration
• Previous experience in IRB
• IRB Certification preferred

Preferred:

• Advanced degree (Master's or higher) in Life Sciences, Regulatory Affairs, Health Administration, or a related field or Bachelor's degree with equivalent experience

• Minimum of seven (7) years of progressively responsible experience in clinical research regulatory affairs supporting multicenter clinical research studies as described above

• Minimum of three (3) years of leadership experience managing regulatory affairs and safety operations related personnel

• Demonstrated experience supporting FDA-regulated clinical trials, including IND and/or IDE studies

• Strong knowledge of FDA regulations, ICH-GCP guidelines, human subjects protections, informed consent requirements, IRB processes, and clinical trial regulatory documentation and compliance requirements

• Experience with applicable submissions to the FDA, IRB, HC, and other regulatory bodies as required

• Excellent leadership, organizational, interpersonal and communication skills supporting collaboration with investigators, sponsors, regulatory authorities, participating institutions, oversight committees, and multidisciplinary teams

• Ability to manage multiple studies and competing deadlines in a fast-paced environment.

• Exceptional attention to detail and documentation practices.

• Proficiency with Microsoft Office applications, version control of critical documents, and electronic regulatory management systems.

• Regulatory Affairs Certification (RAC) or Certified Clinical Research Professional (CCRP/CCRC) certification

• Knowledge of European Union Clinical Trials Regulation (CTR), GDPR, United Kingdom data protection requirements

• Experience supporting multicenter clinical research networks, or similar coordinating center environments in a CRO, ARO, or sponsor environment

• Experience with FDA inspections and sponsor audits

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.