Lead Interdisciplinary Scientist, GS-405-601-660-1320-14


Vacancy ID: 844510   Announcement Number: HHS-FDA-CDER-MP-13-844510   USAJOBS Control Number: 338011000

Occupational/Assessment Questions:

1. Please select the response below that best indicates how you meet the basic education requirement for the Pharmacologist, GS-0405 position.

A. I possess a 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. (Courses in chemistry, organic chemistry, biochemistry, general physiology, and animal, human, microbial, or cellular physiology may be used to meet the 30-semester hour requirement in chemistry and physiology. Courses in pharmacology, pharmacodynamics, pharmacotherapy, molecular pharmacology, and other similar subjects may be used to meet the 12-semester hour requirement in pharmacology. Courses dealing intensively with pharmacologically-oriented subjects may also be used to meet this requirement.)
B. I do not possess the education as described above.

2. Please select the response below that best indicates how you meet the basic education requirement for the General Health Scientist, GS-0601-14 position.

A. I possess a four-year bachelor's degree with a major study in an academic field related to the health sciences or allied sciences appropriate to the work of the position. (You must submit transcript at time of application)
B. I do not possess the education requirement described above.

3. Please select the response below that best indicates how you meet the basic education requirement for the Pharmacist, GS-0660 position.

A. I possess a four-year bachelor's degree in pharmacy from a program recognized by the American Council on Pharmaceutical Education AND I possess a license to practice Pharmacy in a State, territory of the United States, or the District of Columbia. You must provide a copy of your license and reference the details of your license in your resume.
B. I do not possess the education and licensure as described above.

4. Please select the response below that best indicates how you meet the basic education requirement for the Chemist, GS-1320 position.

A. I have successfully completed a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in the physical sciences, life sciences, or engineering that included 30 semester hours in chemistry, supplemented by course work in mathematics through differential and integral calculus, and at least 6 semester hours of physics.
B. I possess a combination of education and experience. This includes course work equivalent to a major as shown in A above, including at least 30 semester hours in chemistry, supplemented by mathematics through differential and integral calculus, and at least 6 semester hours of physics, plus appropriate experience or additional education.
C. I do not possess the education and/or experience described above.

5. Please select the response below that best reflects your experience in relation to the minimum qualifications for this position.

A. I possessĀ one year of specialized experience equivalent to at least the GS-13 level in the Federal service that included serving as a senior advisor responsible for issues relating to clinical pharmacology and biopharmaceutics reviews; designing studies relating to specific drug issues; and representing an office at crucial meetings with industry related to pharmacology and biopharmaceutics activity.
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.

6. Participate in clinical pharmacology aspects in drug development in industry or in a regulatory agency.

7. Review, evaluate, and decide on the approvability of regulatory submissions and applications that request FDA.

8. Serve as an advisor to management on issues pertaining to clinical pharmacology reviews.

9. Serve as an advisor to management on issues pertaining to biopharmaceutics reviews.

10. Evaluate study results of pharmacokinetic studies.

11. Evaluate study results of pharmacodynamic studies.

12. Develop techniques to optimize the review of Investigational New Drug and New Drug Applications.

13. Design studies related to drug-drug interaction.

14. Conduct studies related to bioequivalence.

15. Recommend studies related to in vitro and in vivo human metabolism and transport studies.

16. Review, analyze and interpret sponsor proposals and study results.

17. Make decisions related to safety/efficacy/labeling of drugs/drug products.

18. Meet with representatives of the regulated firms with particular problems in the area of regulatory expertise, and maintains continuing liaison with the organization.

19. Represent the discipline at critical meetings with industry involving "state of the science and therapeutics" in order to include the most advanced theories and practices in a specific therapeutic area.

20. Brief higher level management on long range and emerging problems of drug safety, efficacy, and dosing.

21. Advise upper level management of products under review.

22. Assist other scientists in the preparation of New Drug Application briefings.

23. Address professional groups in clinical pharmacology and biopharmaceutics in mission affected areas.

24. Lead task force or study group to consider general problems or specific solutions in the areas of pharmacokinetics and pharmacodynamics.

25. Develop proposals for study and speaks for the organization on specific scientific specialty to the professional and academic communities and to the regulated industry.

26. Composes scientific, technical, or complex documents.

27. Develop or edits interpretive materials for the organization.