Director, Office of Regulatory Affairs

Director, Office of Regulatory Affairs

Division of Microbiology and Infectious Diseases

National Institute of Allergy and Infectious Diseases

National Institutes of Health

Department of Health and Human Services

The National Institute of Allergy and Infectious Diseases (NIAID) is seeking an exceptional leader to be the director, Office of Regulatory Affairs (ORA) in the Division of Microbiology and Infectious Diseases (DMID). DMID is the lead extramural research division within NIAID responsible for research on all infectious human pathogens other than HIV and all infectious diseases other than AIDS. DMID’s clinical research efforts include tuberculosis, malaria, influenza, emerging infectious diseases, and other public health threats where industry interest is low. These diseases carry an enormous human burden and pose important scientific challenges.

DMID seeks exceptional candidates for the ORA director position.

The ORA director leads and coordinates a broad and complex range of clinical and non-clinical regulatory and related activities that guide the design, development, implementation, and oversight of DMID-sponsored extramural clinical research and product development. This research includes clinical trials conducted at clinical trial networks and individual clinical trials with industry partners. DMID supports up to $200 million per year in clinical research activities in approximately 30 countries and holds approximately 80 active Investigational New Drug Applications (IND) at any time.

The ORA director is responsible for ensuring compliance with federal regulations and policies for protection of human subjects and oversight of DMID's interactions with the HHS Office of Human Research Protection, directing the preparation of INDs, and negotiating clinical trials agreements with outside partners. The director is also the principal liaison between DMID and the Food and Drug Administration (FDA) on regulatory matters.

Additional responsibilities of the director include establishment and monitoring of clinical research quality assurance standards and operating procedures; providing expert advice, consultation, and guidance to DMID scientific staff on regulatory, clinical development, and product development issues; leading the establishment of clinical development plans to support licensure of biodefense products; and managing an ORA regulatory team to oversee and monitor production, safety testing, and assay development in support of DMID biodefense investigational products initiation. The ORA director supervises a staff of 21 federal employees and contractors.

Qualifications

Applicants must have an M.D. or other doctoral degree in microbiology or related field with a comprehensive command of federal regulations related to the conduct and oversight of clinical trials and clinical research. Applicants must have documented expertise and experience in FDA regulatory affairs and review; preparation and processing of IND applications and product license applications; product development and clinical development planning; and vaccine and/or drug development.

Application

Provide your curriculum vitae, bibliography, and a three-page statement explaining your reason for interest in this position, as well as relevant professional experience in regulatory oversight of clinical trials and in designing and implementing regulatory strategies for products designed to prevent, diagnose, or treat infectious diseases. In addition, up to three letters of professional reference may be required as the recruitment process progresses. Submit your application package by email to Lily Martin (lily.martin@nih.gov). The deadline for receipt of applications is January 19, 2019.

Email Lily Martin (lily.martin@nih.gov) with questions or for more information about the position.

All information provided by applicants will remain confidential and will be reviewed only by authorized NIAID officials. The successful candidate will be appointed under the Title 42(f) authority at a salary commensurate with experience but not exceeding $212,000. A full package of benefits is also available, including retirement; health, life, and long-term care insurance; annual and sick leave; and a thrift savings plan (401k equivalent).

Visit NIAID Careers for more information about working in NIAID’s dynamic atmosphere.

HHS, NIH, and NIAID are equal opportunity employers.