Clarification from the agency

You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration. This is a 21st Century Cures Act authority announcement. Traditional federal rules regarding rating, ranking, and veterans' preference do not apply.

• 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.
• Communicates conclusions on the first-in-human (FIH) dose range, and the clinical limit dose to the multidisciplinary review team and proposes clinical safety monitoring based on nonclinical data.
• 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.
• Evaluates whether non-clinical sections of product labeling have accurate and adequate information to communicate the safety and risks of use to patients.
• Provide advice and guidance for product development regarding those aspects of the application that are within the area of activity/proof-of-concept, animal studies, and safety assessment.
• Meets with industry representatives to discuss non-clinical studies needed in support of INDs, NDAs, or BLAs.

Conditions of employment

• U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
• The candidate selected for this position will serve under a career or career-conditional appointment within the competitive service.
• Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice.
• FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the matter.
• Males born after December 31, 1959, must be registered with the Selective Service. Please go to http://www.sss.gov for more information.
• Financial Disclosure may be required.
• Ethics Clearance may be required.
• Background Investigation Requirement: All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time.
• Certification of Accuracy: All information concerning eligibility and qualification is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection, or appropriate legal action.
• Probationary periods are required for new employees appointed to competitive service positions for the first time; or reinstated employees who return after a break in service of 30-days or more and who have not completed a probationary period.

Qualifications

In order to qualify for the Toxicologist position which falls under the 0415 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 performing research, analytical, advisory, or other professional and scientific work in the discipline of toxicology, 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 3 years of comparable experience performing research, analytical, advisory, or other professional and scientific work in the discipline of toxicology, 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/or JD degree and also have 1 year of comparable experience performing research, analytical, advisory, or other professional and scientific work in the discipline of toxicology, 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.
OR
Have six (6) years of comparable experience performing research, analytical, advisory, or other professional and scientific work in the discipline of toxicology, 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.

NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.

How you will be evaluated

You will be evaluated for this job based on how well you meet the qualifications above.

You will be evaluated for this job based on how well you meet the qualifications above. This is a Title 21 announcement. Traditional rating and ranking of applications, and veterans' preference does not apply to this vacancy.

If you are referred to the hiring manager for consideration, you may be further evaluated based on an interview; review of requested work samples, writing samples, most recent performance evaluation(s), or professional references; or results of an oral presentation or work-related test.
Failure to comply with any of the additional assessment requirements will result in removal from further consideration.

Please follow all instructions carefully. Errors or omissions may affect your eligibility.

Resume: At a minimum, your resume should list the position title, employer name, start and end dates (including month and year), salary (or grade and step), hours worked per week, and a list of duties performed or accomplishments, for EACH position listed. A CV (curriculum vitae) may not contain enough information to meet these resume requirements.

• USAJobs - What to Include
• USAJobs - Page Limit

Your two (2) page RESUME showing all relevant work experience (paid and unpaid) including: duties performed; full name and address of each employer; start and end dates (month/day/year); work schedule (part-time, full-time, number of hours if intermittent); salary; and any completed education and training (program title, subject area, number of hours completed, and completion date).

• Cover Letter
• DD-214/ Statement of Service
• Disability Letter (Schedule A)
• Disability Letter (VA)
• License
• Other supporting documentation not listed above
• PCS Orders
• Performance Appraisal
• Professional Certification
• Resume
• Separation Notice (RIF)
• SF-15
• SF-50/ Notification of Personnel Action
• Transcript

Next steps