Science Policy Analyst

Monitors and coordinates the development and implementation of guidance, workshops, research projects, grants, and stakeholder engagement designed to facilitate, support, and accelerate the development of drugs and therapeutic biologics.

Provides scientific expertise in the development of policies, procedures, and activities to ensure consistency in the application of biomarkers in regulatory decision-making and new drug application reviews.

Reviews submissions to the Drug Development Tool (DDT) Qualification Programs.

Reviews submissions to the biomarker qualification and Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot programs for drug development tools seeking qualification.

Provides relevant input to review divisions on questions of biomarker validation and standards of evidence by utilizing knowledge related to the regulatory review processes.

Provides recommendations regarding reviewability of biomarker submissions and suggests which disciplines should be consulted to review biomarker submissions.

Evaluates how measurement of the biomarkerin clinical trials can aid in selecting patients for clinical trials and evaluate if patients respond to and/or benefit from.

Participates in designing, developing, and implementing programs to facilitate the education of stakeholders on the use of biomarkers in drug development.

Assists in maintaining professional relationships with external stakeholders under supervisory oversight.

In order to qualify for the Science Policy Analyst position which falls under the 0601 occupational Series, you must meet the following requirements by 11:59 pm EST on 07/24/2026: Basic Qualification Requirements: Education Bachelor's or graduate/higher level degree: major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position.

This degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education(external link) at the time the degree was obtained. NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.