The National Center for Complementary and Integrative Health (NCCIH), a research component of the National Institutes of Health (NIH) and the Department of Health and Human Services (HHS), is seeking an exceptional, industrious, agile leader to serve as director of its Office of Clinical and Regulatory Affairs (OCRA), responsible for evaluating, coordinating, and monitoring the NCCIH extramural clinical research program. The position is located at the NIH in Bethesda, Maryland.
The director of OCRA reports to the Deputy Director, NCCIH, and will serve as a member of the NCCIH senior leadership team, working collaboratively across the Center and NIH, throughout the Federal Government, and with other key stakeholders and organizations to further the advancement of NCCIH’s mission and objectives. The preferred candidate will have a remarkably broad range of skills and experience in clinical research and clinical trials, and superior managerial and financial qualifications to effectively manage program staff to facilitate safe implementation of NCCIH-funded clinical studies, oversee NCCIH-appointed Data and Safety Monitoring Boards, and ensure regulatory compliance for NCCIH-initiated projects, including compliance with U.S. Food and Drug Administration (FDA) regulations.
Prior to initiating clinical projects, the OCRA director facilitates finalizing study designs, analytic plans, and clinical study documents. In the oversight of clinical research, the director works with NCCIH program staff, the principal investigator, and the grantee institution to address issues related to minimizing risk to research participants; maximizing the success, scientific potential, and impact of funded work; and maximizing productivity and relevance of programs. Moreover, the director facilitates ongoing communication between study teams and NCCIH staff and regularly obtains reports from active clinical studies regarding participant accrual, as well as data and safety monitoring. The director serves as an ambassador and spokesperson for the Center, communicating NCCIH’s position and incorporating the views/needs of key stakeholders into Center plans and initiatives. The OCRA director facilitates the identification and development of future leaders through mentoring programs, continuous development of skills and expertise, and recognition of achievements. This individual also serves as a role model to the rest of the Center, managing people and financial resources with integrity and fairness, while maintaining the Center’s policies and priorities.
The best qualified applicants possess a M.D. or equivalent degree in a biomedical or related field. Preferred qualifications also include specialties in pain research, clinical trials, laboratory medicine, translational sciences, cardiovascular sciences, or other specialties that investigate the use and efficacy of complementary and integrative health interventions. Applicants must have excellent knowledge of the research methods, advanced principles, theories, and policies and practices applicable to the diversity of complementary and integrative health interventions. The candidate must be able to demonstrate enhanced experience with clinical studies, research designs, and approaches that draw on biomedical and behavioral research studying procedural interventions, behavior change, and outcomes of health interventions in real world or practice-based populations. The ideal candidate will also possess a clinical research portfolio exemplifying the study of the safety, ethics of clinical research oversight, and potential application of complementary and integrative health interventions.