Job Summary
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
Required Qualifications
To be eligible for this position, candidates must be a U.S. citizen, or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration. Candidates must indicate their U.S. citizenship status on their CV or within their email application submission.
In order to qualify for this position, candidates must possess either a doctoral-level degree in biomedicine or a biological related field, or a master's level or higher degree in:
- engineering
- bioinformatics
- or an emerging or related scientific field.
In addition, candidates must have at least one year of experience related to the position, including achievements in one or more of the following areas to demonstrate the individual has received recognition as an expert in the field:
- Has significant experience dealing with complex, precedent-setting evaluation issues, including those arising during product development that involved significant scientific controversy, had far reaching implications for clinical research or resulted in a widespread economic effect in the health-care delivery system
- Has taken an active role in the development of significant scientific or regulatory guidelines for clinical research evaluation
- Received invitations to speak at or to chair major national or international meetings and symposia or
- Meets other criteria demonstrating sufficient rigor or accomplishment in a relevant or closely related field that is necessary to the accomplishment of NIH's mission.
If you are a current Federal Title 5 employee, you must have one year of equivalent experience at the GS-14 level or above.
Benefits
A career with the U.S. Government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Learn more about federal benefits.
Equal Employment Opportunity
The United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor. Equal Employment Opportunity (EEO) for federal employees & job applicants.
Standards of Conduct/Financial Disclosure
If selected, you will be required to complete a Confidential Financial Disclosure Report, OGE Form 450 to determine if a conflict or an appearance of a conflict exists between your financial interest and your prospective position with the agency.
Foreign Education
This position has an education requirement. You are strongly encouraged to submit a copy of your transcripts (or a list of your courses including titles, credit hours completed and grades). Unofficial transcripts will be accepted in the application package. Official transcripts will be required from all selectees prior to receiving an official offer. Learn more about Foreign Education.
Reasonable Accommodation
You can request a reasonable accommodation at any time during the application or hiring process or while on the job. Requests are considered on a case-by-case basis.
