Biologist
What you'd do
This position is being filled under a stream-lined hiring authority, Title 21 of the United States Code (21 US Code 379d-3a) as amended by the 21st Century Cures Act of 2016, section 3072 and the Consolidated Appropriations Act of 2023, Section 3624. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority. This position is being recruited based on the Title 21 Pay Table 1, Band C, $121,785 - $169,583.
Major duties
Reviews in silico, in vitro, ex-vivo, and animal data submitted to investigational New Drug Applications(INDs), New Drug Applications(NDAs),and Biological License Applications(BLAs). Employs advanced scientific knowledge for human dose selection that integrates medicinal products' pharmacology, molecular and cellular biology, systems biology, and safety profile. Communicates conclusions on the FIH dose range, and the clinical limit dose to the multidisciplinary review team and proposes clinical safety monitoring based on nonclinical data. Applies scientific and regulatory knowledge to address critical and novel problems, and extends and modifies approaches, precedents, and methods to solve a variety of issues related to drug safety. Reviews non-clinical data throughout the drug development process and communicates new safety findings to the FDA review team. Evaluates specialized non-clinical studies, such as animal efficacy studies via the Animal Rule for medical countermeasures. Meets with industry representatives to discuss non-clinical studies needed in support of INDs, NDAs, or BLAs, to provide advice and guidance for product development.
What you need to qualify
In order to qualify for the Biologist position which falls under the 0401 occupational Series, you must meet the following requirements by 11:59 pm EST on 07/27/2026: Basic Qualification Requirements: Have a bachelor's or higher degree in biological sciences, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position. or Have a combination of education and experience in courses equivalent to a major, as shown above, plus appropriate experience or additional education. AND RELEVANT YEARS OF EXPERIENCE: IN ADDITION TO MEETING THE BASIC REQUIREMENTS OUTLINED ABOVE, APPLICANTS MUST ALSO MEET ONE OF THE FOLLOWING MINIMUM YEARS OF EXPERIENCE REQUIREMENTS. Have a bachelor's degree and also have four (4) years of comparable experience in biological sciences (e.g., molecular, cellular, or systems biology, pharmacology, or toxicology), performing research, analytical, advisory, or other professional and scientific work in this disciplines, including the study of adverse effects of chemical substances and physical agents on living organisms and/or the environment, and the assessment of the probability of their occurrence under specified conditions of use or exposure. OR Have a master's degree and also have three (3) years of comparable experience in biological sciences (e.g., molecular, cellular, or systems biology, pharmacology, or toxicology), performing research, analytical, advisory, or other professional and scientific work in this disciplines, including the study of adverse effects of chemical substances and physical agents on living organisms and/or the environment, and the assessment of the probability of their occurrence under specified conditions of use or exposure. OR Have a doctorate and/or J.D. degree and also have one (1) year of comparable experience in biological sciences (e.g., molecular, cellular, or systems biology, pharmacology, or toxicology), performing research, analytical, advisory, or other professional and scientific work in this disciplines, including the study of adverse effects of chemical substances and physical agents on living organisms and/or the environment, and the assessment of the probability of their occurrence under specified conditions of use or exposure. OR Have a MD/DO/DDS/DPM/DVM degree. NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.
Before you apply
Federal applications are different: your resume should be 3–5 pages and mirror the language of this announcement. Read our federal resume guide first — it's the #1 reason qualified people get screened out.
Don't miss the next one.
Get an email the moment a similar federal job opens — postings can close in as little as 5 days.