Director, Office of Pharmaceutical Research Management
: Job Details :

Job SummaryThe 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 managing and supporting basic, preclinical, and clinical research to understand, treat, and prevent immune-mediated diseases and 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.Responsibilities

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 QualificationsTo 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:

Significant experience dealing with complex, precedent-setting evaluation issues during product development that involved significant scientific controversy.

Active role in the development of significant scientific or regulatory guidelines for clinical research evaluation.

Invitations to speak at or chair major national or international meetings and symposia.

Other criteria demonstrating sufficient rigor or accomplishment in a relevant or closely related field 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.BenefitsA 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.Equal Employment OpportunityThe 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.Job Details

Open Date: Mon, 08/26/24

Close Date: Tue, 09/24/24

IC: NIAID (National Institute of Allergy and Infectious Diseases)

Division: Allergy, Immunology, and Transplantation

Location: Rockville, MD

Pay: Commensurate with qualifications and experience

How to ApplyInterested candidates should submit the following to the NIH Specialized Scientific Jobs portal by September 24, 2024:

Curriculum vitae (CV)

A two-page statement describing your experience and expertise in developing a manufacturing and distribution strategy for pharmaceutical products for Phase 1 through 4 clinical trials, the reasons for your interest in the position, and the leadership skills and experience you would bring to NIAID.

A statement describing your experience mentoring and promoting a diverse workforce.

Applications from women, and individuals from groups underrepresented in biomedical research are strongly encouraged.#J-18808-Ljbffr