Code of Federal Regulations Title 42. Public Health § 42.24.4 Eligibility

(1) Has earned a doctoral level degree in biomedicine or a related field, or a doctoral or master's level degree in engineering, bioinformatics, or a related or emerging field;  and

(2) Meets the qualification standards prescribed by the Office of Personnel Management for appointment to a position at GS–15 of the General Schedule.

(1) Conducted original research that has been published in peer-reviewed journals of high stature;

(2) Received major prizes and awards (such as visiting professorships and named lectureships) in recognition of original contributions to research;

(3) Received invitations to speak at or to chair major national or international meetings or symposia;

(4) Been elected to membership in professional societies of high stature;  or

(5) Meet other criteria demonstrating sufficient rigor or accomplishment in a field that is relevant and necessary to the accomplishment of the agency's mission.

(1) 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;

(2) Taken an active role in the development of significant scientific or regulatory guidelines for clinical research evaluation;

(3) Been the recipient of invitations to speak at or to chair major national or international meetings and symposia;  or

(4) Meet other criteria demonstrating sufficient rigor or accomplishment in a field that is relevant and necessary to the accomplishment of the agency's mission.

(1) Significant experience dealing with complex, precedent-setting evaluation, scientific policies or development issues (e.g., those associated with novel biomedical products, novel approaches to biomedical product-manufacturing, or use of novel evaluation methods);

(2) Demonstrated cutting-edge expertise in a scientific or technical discipline critical to design, development, manufacturing, clinical performance assessment, or other technical aspects of effective oversight of biomedical products;

(3) Played a leadership role in planning and conducting public meetings to seek public input and communicate regulatory scientific policies;

(4) Been the recipient of invitations to speak at or to chair major national or international meetings and symposia;  or

(5) Meet other criteria demonstrating sufficient rigor or accomplishment in an activity or field that is relevant and necessary to the accomplishment of the agency's mission.