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Announcement #877111500

Pharmacologist

Food and Drug Administration · Silver Spring, Maryland
Open to the publicTelework eligible

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 2, Band C $121,785 - $191,352.

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). Uses non-clinical data to recommend a first-in-human (FIH) dose range that is safe within the clinical trial context and therapeutic in patients. Employs advanced scientific knowledge for human dose selection that integrates medicinal products’ pharmacology, molecular and cellular biology, systems biology, and safety profile. Evaluates whether non-clinical sections of product labeling have accurate and adequate information to communicate the safety and risks of use to patients. Evaluates specialized non-clinical studies, such as animal efficacy studies via the Animal Rule for medical countermeasures, as needed. Provides comprehensive summary and integrated evaluation of the non-clinical data submitted in INDs (and amendments), NDAs, and BLAs (and supplements) are prepared for supervisory concurrence. Makes regulatory recommendations, such as clinical hold (INDs), and drug approval (NDAs/BLAs) decisions, based on non-clinical data.

What you need to qualify

In order to qualify for the Pharmacologist position which falls under the 0405 occupational Series, you must meet the following requirements by 11:59 pm EST on 07/27/2026: Minimum Qualification Requirements: Possess a bachelor's degree or higher in toxicology, pharmacology, environmental sciences, medicinal chemistry, pharmaceutical sciences, or related sciences. The degree must be from an accredited program or institution. OR Possess an American Board of Toxicology Certification. AND 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 4 years of comparable experience analyzing and advising on the history, sources, physical and chemical properties, biochemical, toxic and physiological effects, mechanisms of action, absorption, distribution, metabolism, biotransformation and excretion, and therapeutic and other uses of drugs as well as modern pharmacological techniques.OR Have a Master's degree and also have 3 years of comparable experience analyzing and advising on the history, sources, physical and chemical properties, biochemical, toxic and physiological effects, mechanisms of action, absorption, distribution, metabolism, biotransformation and excretion, and therapeutic and other uses of drugs as well as modern pharmacological techniques.OR Have a Doctorate/or JD degree and also have 1 year of comparable experience analyzing and advising on the history, sources, physical and chemical properties, biochemical, toxic and physiological effects, mechanisms of action, absorption, distribution, metabolism, biotransformation and excretion, and therapeutic and other uses of drugs as well as modern pharmacological techniques.OR Have a MD/DO/DDS/DPM/DVM degree.OR Have six (6) years of comparable experience analyzing and advising on the history, sources, physical and chemical properties, biochemical, toxic and physiological effects, mechanisms of action, absorption, distribution, metabolism, biotransformation and excretion, and therapeutic and other uses of drugs as well as modern pharmacological techniques. NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.

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