Toxicologist


Vacancy ID: 760251   Announcement Number: HHS-FDA-CDER-MP-12-760251   USAJOBS Control Number: 328116500

Occupational/Assessment Questions:

1. From the descriptions below, select the letter that best describes your eligibility for this position. You MUST select one response or you will be rated ineligible.

A. I currently work for the Office of New Drugs (OND) in the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), with a career or career-conditional appointment in the competitive service or in the Public Health Service.

B. I do not currently work for the Office of New Drugs (OND) in the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), with a career or career-conditional appointment in the competitive service or in the Public Health Service.

2. Please select the response below that best indicates how you meet the basic education requirement for a Toxicologist position. Remember, if your answer is 'A' below, you MUST provide a copy of your college transcript.

A. I possess a Bachelor's or higher degree in toxicology; or an appropriate discipline of the biological, medical, or veterinary sciences that included at least 30 semester hours in chemistry, biochemistry, or physiology, and 12 semester hours in toxicology.   (Courses in anatomy, chemistry, organic chemistry, biochemistry, biology, histology, and animal, human, microbial, or cellular physiology may be used to meet the 30-semester-hour requirement in chemistry, biochemistry, and physiology. Courses in statistics, bioassay, and test design may also apply to this requirement. Courses in cytology, embryology, cellular or microbial genetics, and biophysics may also be used to meet this requirement in those instances where the course work provided additional insight into the biophysical, biochemical, and physiological relationships involved. Only toxicology courses may be used to meet the requirement for 12 semester hours in toxicology. This may include courses dealing intensively with toxicological search, methods in toxicology, essentials of toxicology, the study and review of toxicological literature, special reading courses, or other toxicologically-oriented subjects.)

B. I do not possess the education described above.

3. Please select the response below that best indicates how you meet the minimum qualifications for a GS-0415-14, Toxicologist.

A. I possess one year of experience, equivalent to at least the GS-13 level in the Federal service. This experience includes: reviewing scientific submissions focusing on non-clinical in vitro and animal data and evaluation of toxicological potential of drugs in support of proposed clinical studies or proposed dosage regimens in the labeling; reviewing the results of non-clinical pharmacological and toxicological studies submitted by the drug sponsor/applicant in support of Investigational New Drug Applications (INDs), New Drug Applications (NDAs), and Biologic Licensing Applications (BLAs) amendments, supplements and other related scientific submission to assess the safety of the drug; preparing comprehensive summaries and integrated discussions of data submitted for review.

B. I do not possess the experience described above.

In this part, you will respond to questions about experiences you have had that are related to the requirements of the job for which you are applying. Carefully review the response descriptions listed below. For each question or statement, select the one response description that best describes your experience, education, or training.

A- I have not had education, training or experience in performing this task.
B- I have had education or training in performing this task, but have not yet performed it on the job.
C- I have performed this task on the job. My work on this task was monitored closely by a supervisor or senior employee to ensure compliance with proper procedures.
D- I have performed this task as a regular part of a job. I have performed it independently and normally without review by a supervisor or senior employee.
E- I have supervised performance of this task or am normally the person who is consulted by other workers to assist them in doing this task because of my expertise.

4. Review and evaluate scientific submissions focusing on non-clinical in vitro and animal data.

5. Evaluate toxicological potential on all organ systems, tissues, and cells, and on the animal in general.

6. Review and evaluate the results of non-clinical toxicological and pharmacological studies submitted by the drug sponsor/applicant.

7. Serve as a resource for information on current concepts in toxicology and pharmacology.

8. Maintain expert knowledge and keep abreast of new findings by reading toxicological, pharmacological, biochemical and immunological scientific literature, participating in professional meetings.

9. Apply new developments and theories to critical and novel problems.

10. Extend and modify approaches, precedents and methods to solve a variety of toxicology problems with unprecedented and obscure aspects.

11. Serve as a resource for information on current concepts in toxicology and pharmacology.

12. Submit substantive regulatory recommendations and conclusions for concurrence by the scientific supervisor.

13. Meet with industry representatives to exchange information and to provide advice and guidance regarding those aspects of the application, notice, amendment, supplement or report which fall within area of review.

14. Attend meetings, conferences, and symposia of scientific organizations to remain aware and gain an understanding of developments in the field.

15. Understand new guidance in order to keep abreast of current trends relative to work assignments.

16. Participate in professional committees and working groups.

17. Prepare comprehensive summaries and integrated discussions of data submitted for review.

18. Provide consultative service to other centers as well as other agencies within the Government.

19. Provide guidance and/or regulatory expertise to address and solve complex regulatory issues consistent with technological developments or new scientific evidence.