Job Posting: Supervisory Senior Biomedical Research and Biomedical Product Assessment Service (SBRBPAS) Expert

Summary

The National Center for Advancing Translational Sciences (NCATS), a major research component of the National Institutes of Health (NIH), is seeking applications from exceptional candidates with real-world expertise in clinical trial design and methods, and experience in multiple disciplines, including innovative safety assessments, digital and non-digital trial innovations, and innovations in trial regulatory efficiency. Candidates should have recognized and objective demonstration of national leadership in clinical trials, have successfully led clinical trials in a complex structure, and have demonstrated expertise in improving clinical trial efficiency through tool development, clinical trial training and education. The selected candidate also will be expected to broaden the scope of clinical trial questions and the clinical trial enterprise so that trials address the health concerns of people in a broad variety of situations and locations, including those living in rural and remote locations.

The section chief will be responsible for developing strategies to test, disseminate and incorporate the tools developed by this section and elsewhere, ensuring the dissemination and sustainability of these tools within NCATS-funded programs, NIH and the extramural research community. Dissemination should include a variety of organization types and geographic locations. To facilitate this, the Trial Innovation Network section chief will work with clinical trial networks and training programs through NIH and non-NIH programs to ensure that the tools are accessible and used appropriately. This process will be iterative and broadly informed to make sure the needs of participants, families, communities, providers and researchers are optimized.

The section chief will also be responsible for understanding and advancing the opportunities and challenges of artificial intelligence in clinical trials and provide national leadership regarding this challenge in conjunction with the branch chief.

Clinical trials are balanced by understanding efficacy/effectiveness and outcome measures, but safety is paramount. Therefore, the section chief will be responsible for tool development that highlights, flags or streamlines safety issues. The position will include trial safety oversight.

This position is under the Silvio O. Conte Senior Biomedical Research and Biomedical Product Assessment Service (SBRBPAS) Title 42 U.S. Code § 237 Authority and will serve as the chief of the Trial Innovation Section which is in the Clinical and Translational Science Awards (CTSA) Program Clinical Affairs Branch, which is in the Division of Clinical Innovation (DCI). Under this authority, the official title is Supervisory SBRBPAS Expert. This specific position fills an indefinite excepted service position; SBRBPAS employees serve at the will of the agency and do not serve trial or probationary periods.

Duties

Core Responsibilities
The Supervisory SBRBPAS Expert within the Clinical Affairs Branch is responsible for providing leadership and overseeing activities of the Trial Innovation Section. The incumbent also interacts directly with the Chief of the Clinical Affairs Branch and collaboratively with the Clinical Research Resources Section on vision and strategy regarding the Center’s mission and collaborations across and beyond the NIH.

The Trial Innovation Network section chief will be responsible for providing authoritative, technical and scientific leadership and guidance for the clinical trial activities within DCI and when needed by NCATS and NIH. The section chief will direct the activities of the section, including providing a national resource for rapid response to public health emergencies via the Trial Innovation Network and promoting the identification, development and dissemination of innovative clinical trial designs and recruitment strategies. The section chief will develop and provide resources for the planning, implementation and conduct of NIH-supported clinical trials. The section’s products and resources aim to improve clinical trial efficiency, maximize safety and enhance the types of information within clinical trials. Examples of the activities within the section will include the implementation of techniques/tools to enhance trial design, trial safety, site selection efficiency, Institutional Review Board efficiency, startup and expansion efficiency, realistic cost, and time calculations for both NIH and investigator expectations, personnel, and site turnover issues.

The section chief will serve as a senior leader, representing DCI and NCATS in clinical and research programs across NIH, other government agencies, industry, academia and patient-support organizations. The section chief will provide advice to the clinical affairs branch chief and the DCI director on trial, safety- and clinical-related matters.

Qualifications
To be eligible for an appointment to the Senior Biomedical Research and Biomedical Product Assessment Service (SBRBPAS), candidates must possess a doctoral level degree in biomedicine or a related biological field; OR Doctoral or master's level degree in engineering, bioinformatics, or a related or emerging field.

The ideal candidate will have extensive real-world experience in clinical trial development and conduct, possess an objective record of accomplishment and innovation, and have experience in trial bottleneck/ barriers, optimization strategies and potential efficiencies. An important aspect of the position will be safety; therefore, the successful candidate will have extensive experience with clinical
safety issues. The ideal candidate will have strong and demonstratable experience in conceiving, developing and testing tools to support clinical trials in novel groups and settings. The successful candidate will also have a strong history of working productively with federal and non-federal organizations and partners.

The ideal candidate must have extensive experience in (1) leading a highly complex trial program and employing strategies for implementing and disseminating trial and products; (2) providing expert advice to senior leaders on scientific and clinically relevant policies and programs; (3) developing innovative training programs for advancing trial tool development, dissemination and usage by trainees; and (4) leading teams. The ideal candidate must appreciate new trends in the clinical trial enterprise, such as the novel use of informatics, big data and site-selection strategies to improve the conduct of trials. The ideal candidate will have the ability to communicate and collaborate productively with others.

Candidates should demonstrate (1) a clear pattern of success in visioning, planning, and analyzing research projects, program objectives and priorities; (2) the ability to communicate and collaborate effectively with scientific and lay audiences; and (3) the ability to form productive collaborations with national and international organizations, as well as with individuals who represent wide-ranging disciplines and competing priorities. The ideal candidate will possess a record of accomplishment and innovation in clinical trial processes and an outstanding record of scientific accomplishment in public- and/or private-sector research. Each applicant must possess a doctoral-level degree in biomedicine or a biological-related field, or a doctoral or master’s level degree in engineering, bioinformatics, or a related or emerging field, as well as senior-level experience, leadership and accomplishment in one or more scientific disciplines of clinical trials.

The preferred candidate will have a Medical Doctorate (M.D.) and an active state medical license.

Who Can Apply

Qualifications

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:

• Conducted original biomedical research published in peer-reviewed journals of high stature
• Received major prizes and awards (such as visiting professorships and named lectureships) in recognition of original contributions to biomedical research
• Received invitations to speak at or chair major national or international meetings or symposia
• Elected to membership in professional societies of high stature, 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), national origin, political affiliation, 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.

How to Apply

Interested individuals should submit applications from October 28 to November 27, 2026 (submission deadline may be extended if needed). Applicants should submit a cover letter describing their interest in the position, a curriculum vitae with a complete bibliography, and 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.

Send your application package to [email protected]. Include your name and Supervisory Senior Biomedical Research and Biomedical Product Assessment Service (SBRBPAS) Expert Position in the subject line. Please submit questions about this position to Tiffany Ward at [email protected].

Review of applications will begin November 30, 2026, and will continue until the position is filled. Employment is subject to the successful completion of a background investigation, verification of qualifications, completion of onboarding forms, submission of required documents, and any other job-related requirement before or after appointment.