Pharmacologist, GS-0405-13


Vacancy ID: 790422   Announcement Number: HHS-FDA-CDER-DE-13-790422   USAJOBS Control Number: 331695300

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 Pharmacologist position. You MUST provide a copy of your college transcript. You must select one response.

A. I have a bachelor's or higher degree in pharmacology.

B. I have a bachelor's or higher degree in an appropriate biological, medical, veterinary, or physical science, or in pharmacy that included at least 30 semester hours in chemistry and physiology and 12 semester hours in pharmacology.
C. I do not meet any of the requirements described 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 Pharmacologist 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 pharmacological and toxicological studies, data, applications, and reports to determine whether use of certain products can result in adverse chronic and/or acute health effects; analyzing and interpreting pharmacological and toxicological 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.