Director, Office of Clinical and Regulatory Affairs (Supervisory Physician)

Position

The National Center for Complementary and Integrative Health (NCCIH), a component of the National Institutes of Health (NIH) and the U.S. Department of Health and Human Services (HHS), seeks to identify an outstanding physician for the position of Director, Office of Clinical and Regulatory Affairs (OCRA). The mission of NCCIH is to define, through rigorous scientific investigation, the usefulness and safety of complementary and integrative health interventions and their roles in improving health and health care.  In support of this mission, NCCIH funds a varied portfolio of grants, including randomized clinical trials and observational and epidemiological studies, with the goals of testing the safety and efficacy of complementary and integrative health approaches and better understanding of “real world” patterns and outcomes of complementary and integrative health interventions and their integration into health care and health promotion.

OCRA serves as a resource for the planning, implementation, and oversight of clinical research funded by NCCIH. The office is staffed by a multidisciplinary team of biostatisticians, clinical trialists, trial specialists, and analysts who work with NCCIH program staff and extramural clinical investigators to help support the implementation of clinical research relevant to NCCIH‘s mission. OCRA plays a crucial role in maximizing the success, scientific potential, and impact of NCCIH-supported clinical research and in minimizing the risk to research participants.

The OCRA Director reports to the Deputy Director, NCCIH, and is responsible for:

• Overseeing issues related to the design, monitoring, and conduct of NCCIH-funded clinical trials of modalities within the field of complementary and integrate medicine 
• Finalizing study designs, analytic plans, and clinical study documents for funded projects
• Tracking of accrual progress and implementation of Data and Safety Monitoring Plans (DSMP) in the extramural clinical research portfolio 
• Organizing and managing NCCIH programs that ensure studies adhere to the highest ethical and regulatory standards governing clinical research 
• Representing NCCIH on clinical trial issues with officials from other Federal agencies such as the U.S. Food and Drug Administration, and with the investigative community
• Serving as a principal advisor to the Director, NCCIH and the Center staff on all matters regarding the planning, conduct, and evaluation of intramural and extramural clinical trials supported by NCCIH

The position is located in Bethesda, Maryland.

Required Qualifications

Applicants must meet the following qualification requirements:

Successful completion of the requirements for Doctor of Medicine or Doctor of Osteopathic Medicine or equivalent from a school in the United States or Canada, or permanent certification by the Educational Commission for Foreign Medical Graduates (ECFMG), or successful completion of the U.S. Medical Licensing Examination; an active, current, full, and unrestricted license or registration as a physician from a state, the District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States; at least 1 year of supervised experience providing direct service in a clinical setting; at least 5 years of graduate training in the specialty to be filled, or 5 years of equivalent experience and training.

Preferred candidates must have excellent knowledge of the clinical research study design, implementation, conduct, barriers, policies, and practices. Leading candidates will have extensive experience in the conduct of Phase 1 through Phase 4 research studies including requirements for Investigational New Drugs (INDs), Investigational Device Exemptions (IDEs), and requirements for conducting behavioral research. NCCIH is seeking candidates with strong interpersonal skills, an ability to manage an office with diverse skillsets, and a deep commitment to promoting a diverse, respectful, and inclusive workplace. 

U.S. citizenship is required. This position is subject to a background investigation. Women, persons from underrepresented groups, and persons with disabilities are strongly encouraged to apply. 

Salary and Benefits

For salary information, refer to the vacancy announcement, which includes position title, series, and grade levels. A full civil service package of benefits (including retirement; health, life, and long-term care insurance; Thrift Savings Plan; etc.) is available. 

How To Apply

To apply, submit an application to the following opening in USAJobs.gov: 

•  Extramural Supervisory Physician (Global Vacancy Announcement NIH-GR-DH-24-12424512)

The application period is open from June 24, 2024 to July 3, 2024 (at 11:59 p.m. ET). Applications must be submitted through USAJobs.gov by the closing date of the announcement.

Contact Annice Lawrence for additional information about the position at NCCIHJobs@mail.nih.gov or 301-594-7939. All questions regarding the application process should be referred to Melissa Roby at melissa.roby@nih.gov or 301-443-8943.

HHS and NIH Are Equal Opportunity Employers