Senior Clinician, Regulatory Affairs

The NIH Clinical Center (CC) is the research hospital of the NIH. It provides medical and support services for patients participating in human subjects research protocols.  In addition to the primary role of supporting intramural Institute clinical research and patient care, CC staff conduct both collaborative and independent research and support a variety of training programs.  The NIH CC supports the NIH intramural clinical research program hosting over 100,000 outpatient visits and 6,600 inpatient admissions a year. 

The NIH Clinical Center’s mission requires the use of a number of investigational drugs and biologics as well as investigational devices. Use of investigational drugs or biologics is regulated by the Food and Drug Administration (FDA) and sponsors have specific detailed documentation and reporting requirements. The CC is currently the sponsor for 24 Investigational New Drug (IND). INDs are an essential research resource requiring detailed preparation and maintenance. Maintaining an IND involves multiple requirements including submission of research protocol and information amendments, safety reports, and annual reports to the FDA and Institutional Review Board. Thus, INDs are essential to the success of the intramural clinical research program for multiple Institutes and Centers as well as the CC. Medical supervision of all reporting and documentation requirements for CC INDs is a critical responsibility only to be entrusted to an experienced Senior Clinician.

Investigational devices (IDEs) are also regulated by the FDA. The NIH Clinical Center is currently the sponsor for 15 IDEs. The incumbent must be familiar with all aspects of FDA oversight and regulatory requirements for investigational devices, both those associated with significant risk and those determined to be no significant risk (NSR).

The position is located within the Warren G. Magnuson Clinical Center, a major research component of the NIH and the Department of Health and Human Services. The incumbent in this position supports the Chief Medical Officer, the Chief Operating Officer, and the Chief Executive Officer of the NIH Clinical Center. Furthermore, since the NIH Deputy Director for Intramural Research (DDIR) is the Institutional Official accountable to the US Food and Drug Agency (FDA) for regulatory compliance with all FDA regulations, the incumbent in this position has a critical role in support of the DDIR as well as the senior leaders of the CC. In fulfilling these responsibilities, the incumbent works closely with the Office of Research Support and Compliance that also supports the CC as well as the DDIR. While IND and IDE management and compliance represent the critical institutional entities associated with this position, the incumbent is also expected to participate in clinical care and research. An independent research program is desirable but not mandatory. The incumbent may also serve in a leadership or supervisory capacity in one of the CC’s Clinical Departments, depending on training, experience, and demonstrated leadership ability.