Toxicologist, GS-0415-13


Vacancy ID: 826587   Announcement Number: HHS-FDA-CDER-DE-13-826587   USAJOBS Control Number: 335833600

Occupational/Assessment Questions:

1. Please read the following statements carefully and select the one response that best describes your education as it pertains to the basic requirements for a Toxicologist position. You MUST provide a copy of your college transcript. You must select one response.

A. 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 research, methods in toxicology, essentials of toxicology, the study and review of toxicological literature, special reading courses, or other toxicologically-oriented subjects.) You must submit transcript(s) at time of application submission. For those applicants who do not meet the specified degree but have the demonstrated coursework above you must provide the transcript(s) demonstrating such coursework at the time of application submission.
B. I do not meet education requirements described in A above.

2. From the descriptions below, select the one statement below that best describes the experience that you have that demonstrates your ability to perform Toxicologist duties. Your response will be verified by reviewing your supporting documents, i.e., resume. Your claimed experience and related duties and responsibilities must be clear on your supporting documents. You must select one response.

A. I have at least 1 full year of specialized experience equivalent to the GS-12 grade level or higher in the Federal service that included: reviewing, evaluating and interpreting toxicological studies, applications, and/or reports to determine whether use of certain products can result in adverse chronic and/or acute health effects; analyzing and interpreting toxicological and pharmacological data with novel and/or obscure technical issues; and providing study results, advice, consultations and scientific information to management, industries and/or organizations.
B. My experience is not reflected in choice A above.

In this section, you are asked to evaluate yourself on task items using the scale provided. When marking your ratings, please do not overstate or understate your level of experience and capability. You should be aware that your ratings are subject to evaluation and verification. Do not give yourself credit for having performed tasks you have not performed. Additional steps in the selection process are designed to verify your stated level of experience and capability. Deliberate attempts to falsify information will be grounds for not selecting you or for dismissing you from employment with the organization.

Read each task carefully. For each task, select the ONE response that most accurately describes your current level of experience and capability. Once you have a clear understanding of these instructions, please mark your self-ratings on the task in this section using the scale below.

A- I have no 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 am considered an expert in performing this task. 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.

3. Evaluate the results of preclinical toxicological and pharmacological studies, such as studies in support of Investigational New Drugs (INDs), New Drugs Applications (NDAs) and/or Biologic License Applications (BLAs).

4. Evaluate the adequacy of preclinical toxicological and pharmacological data, such as data to support planned clinical studies of Investigational New Drug (INDs) applications.

5. Evaluate potential safety of drugs/biologics based on the results of preclinical toxicological and pharmacological studies, in context of planned use in humans.

6. Conduct Good Laboratory Practice-compliant toxicology and pharmacology studies, such as studies to support Investigational New Drugs (INDs), New Drugs Applications (NDAs) and Biologic License Applications (BLAs).

7. Generate study protocols for preclinical studies.

8. Prepare comprehensive study reports/summaries of preclinical toxicological and/or pharmacological data reviewed.

9. Evaluate preclinical animal data to ensure that study supports claims for safety included in proposed labeling.

10. Evaluate in vivo toxicological and pharmacological potential of biologics.

11. Evaluate in vivo toxicological potential of drugs/biologics on organ systems, tissues and/or cells (i.e. General toxicology).

12. Evaluate in vivo toxicological of drugs/biologics on the processes of reproduction and development of the offspring (i.e. Developmental and Reproductive toxicology).

13. Evaluate the results of preclinical safety pharmacology studies (cardiovascular, CNS, respiratory) to determine implications for clinical study design.

14. Evaluate the results of preclinical genotoxicity or carcinogenicity studies.

15. Evaluate the results of preclinical ocular toxicity studies (i.e. drug or biologic administered via the ocular route).

16. Evaluate in vivo models for ocular disease or toxicity.

17. Prepare comprehensive study reports/summaries of preclinical ocular toxicological and/or ocular pharmacological data.

18. Interact with multidisciplinary teams (e.g. Pharmacology/Toxicology, Clinical, Clinical Pharmacology and Chemistry) to provide advice and/or guidance regarding the findings from preclinical studies and safety of drugs/biologics as information is exchanged.

19. Provide advice to industry representatives to address preclinical issues related to regulatory submissions.