Director, Office of Pharmaceutical Research Management

Department of Health and Human Services

National Institutes of Health

National Institute of Allergy and Infectious Diseases

Division of Allergy, Immunology, and Transplantation

The National Institute of Allergy and Infectious Diseases (NIAID), one of the largest institutes in the National Institutes of Health (NIH), and part of the Department of Health and Human Services (HHS), conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases.

The Office of Pharmaceutical Research Management (OPRM) in the Division of Allergy, Immunology, and Transplantation (DAIT) within NIAID seeks an innovative and transformational leader to serve as the Director of OPRM.

DAIT is one of four extramural program divisions within NIAID and is responsible for 1) managing and supporting basic, preclinical, and clinical research to understand, treat, and prevent immune-mediated diseases and 2) developing medical countermeasures against radiation/nuclear injuries.

OPRM is responsible for the pharmacy and pharmaceutical management of DAIT’s national and international clinical trials and ensures investigational product integrity, participant safety, and pharmaceutical regulatory compliance.

The Director of OPRM provides strategic direction, guidance, and oversight of pharmacy and pharmaceutical activities to all DAIT staff and DAIT-supported investigators.

The responsibilities of the Director of OPRM include the following:

• Provide scientific knowledge, leadership, direction, guidance, and oversight on all pharmaceutical aspects of clinical protocol development and conduct
• Ensure study participant safety and assess the clinical trial stability and feasibility of all DAIT-supported national and international clinical trials
• Develop a manufacturing and distribution strategy for pharmaceutical products for Phase 1 through 4 clinical trials
• Provide investigational product management and pharmacy and pharmaceutical support and oversight for DAIT-funded clinical trials
• Serve as the authority on the use of pharmaceuticals in DAIT-funded clinical trials
• Ensure compliance with applicable national and international regulations governing the management of investigational products

Qualifications

Required

U.S. citizenship is required

This position is subject to a background investigation. Salary will be commensurate with experience. A full civil service package of benefits may be available.

To Apply

Interested candidates should submit the following to the NIH Specialized Scientific Jobs portal (https://specializedscientificjobs.nih.gov/nih-ssj.do#/) by September 24, 2024

• Curriculum vitae (CV): In your CV, please include a brief description of your responsibilities
• A two-page statement describing 1) your experience and expertise in developing a manufacturing and distribution strategy for pharmaceutical products for Phase 1 through 4 clinical trials; 2) the reasons for your interest in the position; and 3) the leadership skills and experience you would bring to NIAID
• A statement describing your experience mentoring and promoting a diverse workforce

In addition, up to three letters of professional reference may be required as the recruitment process progresses.

Applications from women, and individuals from groups underrepresented in biomedical research are strongly encouraged.

For more information or questions about the position, email NIAIDExecutiveServices@mail.nih.gov.

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

(https://www.niaid.nih.gov/about/careers?utm_medium=referral&utm_source=websites&utm_campaign=nc_dait_oprm_dir_niaid%20careers_8262024)

HHS, NIH, and NIAID are equal opportunity employers dedicated to diversity, equity, and inclusion. NIH is dedicated to building a diverse community through its training and employment programs.