Supervisory Interdisciplinary Scientist, GS-0405/0660/1320-15


Vacancy ID: 838991   Announcement Number: HHS-FDA-CDER-DE-13-838991   USAJOBS Control Number: 337552400

Social Security Number

Enter your Social Security Number in the space indicated. Your Social Security Number is requested under the authority of Executive Order 9397 to uniquely identify your records from those of other applicants who may have the same name.  As allowed by law or Presidential directive, your Social Security Number is used to seek information about you from employers, schools, banks and others who may know you. Providing your Social Security Number is voluntary, however we can not process your application without it.


Vacancy Identification Number

Enter 838991
1. Title of Job

Supervisory Interdisciplinary Scientist, GS-0405/0660/1320-15
2. Biographic Data

3. E-Mail Address

4. Work Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

5. Employment Availability

Are you eligible for the Federal Employment Program for Persons with Disabilities? (For information on Schedule A appointments, see the OPM website.)


6. Citizenship

Are you a citizen of the United States?
7. Background Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

8. Other Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

9. Languages

If you are applying by the OPM Form 1203-FX, leave this section blank.

10. Lowest Grade

Enter the lowest grade level that you will accept for this position. The lowest grade for this position is 15.


15

11. Miscellaneous Information

If you are a male at least 18 years of age, born after December 31, 1959, have you registered with the Selective Service System?


01 Yes
02 No
03 Not Applicable

12. Special Knowledge

If you are applying by the OPM Form 1203-FX, leave this section blank.

13. Test Location

If you are applying by the OPM Form 1203-FX, leave this section blank.

14. Veteran Preference Claim

15. Dates of Active Duty - Military Service

16. Availability Date

17. Service Computation Date

If you are applying by the OPM Form 1203-FX, leave this section blank.

18. Other Date Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

19. Job Preference

If you are applying by the OPM Form 1203-FX, leave this section blank.

20. Occupational Specialties

Select/enter at least one occupational specialty. The specialty code for this position is:


001 Pharmacologist
002 Pharmacist
003 Chemist

21. Geographic Availability

Select/enter at least one geographic location in which you are interested and will accept employment. The location code for this position is:


241450031 Silver Spring, MD

22. Transition Assistance Plan

If you are applying by the OPM Form 1203-FX, leave this section blank.

23. Job Related Experience

If you are applying by the OPM Form 1203-FX, leave this section blank.

24. Personal Background Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

25. Occupational/Assessment Questions:

1. From the descriptions below, select the one which best describes your education and meets the Basic Qualification Requirements for Pharmacologist, GS-0405.

A. I have a bachelor's degree or higher from an accredited college or university 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, pharmacotherapeutic, 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 and/or experience as described above.

2. From the descriptions below, select the one which best describes your experience which meets the minimum requirement for Pharmacist GS-0660.

A. I have a four-year bachelor's degree or higher from an accredited college or university in pharmacy recognized by the American Council on Pharmaceutical Education. Except for research positions that do not entail patient care, all applicants must be licensed to practice pharmacy in a State, territory of the United States, or the District of Columbia AND one year of professional pharmacy experience equivalent to at least the next lower grade level AND must be able to distinguish basic colors.

B. I do not possess the education and/or experience as described above.

3. From the descriptions below, select the one which best describes your experience which meets the minimum requirement for Chemist, GS-1320.

A. I have a bachelor's degree or higher from an accredited college or university in the physical science, life sciences, or engineering that included at least 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 have a combination of education and experience - courses equivalent to a major that included courses as shown "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 as described above.

4. From the descriptions below, select the one which best describes your experience and meets the Additional Qualification Requirements for 0405/Pharmacologist, 0660/Pharmacist-15, 1320/Chemist.

A. I have one year of specialized experience equivalent to the GS-14 grade level in the Federal service, to include experience in clinical pharmacology and personalized medicine field sufficient to evaluate clinical trials data.
B. I do not possess the experience described above.

For each task in the following group, choose the statement from the list below that best describes your experience and/or training. Darken the oval corresponding to that statement in Section 25 of the Qualifications and
Availability Form C. Please select only one letter for each item.

A- I have not had education, training or experience in performing this task.
B- I have had education or training in performing the 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.

5. Oversee review of the Investigational New Drug Applications to ensure targeted therapy strategies are appropriately promoted and proactively applied to improve risk/benefit relationships, especially through use of innovative drug development methodologies and tools (e.g., trial designs, biomarkers).

6. Oversee New Drug Applications (NDAs) and Biologic Licensing Applications (BLAs) to ensure that issues around therapeutic individualization have been adequately addressed to inform regulatory decisions, drug labeling, and post-marketing studies.

7. Survey approved drugs to identify opportunities to incorporate pharmacogenomics information into drug labeling, improving benefit/risk balance.

8. Plan, manage, organize and direct all operations, research activities, and educational efforts of a group as carried out by subordinate supervisors and/or team leaders and highly trained and skilled staff.

9. Evaluate budget, fiscal, and administrative controls to manage the group's program segment(s) and services.

10. Direct the preparation, clearance, and finalization of the group's program responses to inquiries covering all aspects of the programs, functions, and activities of the group.

11. Develop and implement policies and procedures related to pharmacogenomics/targeted therapy in early and late phase clinical trials.

12. Develop new policies and procedures related to the regulatory evaluation of biomarker-drug combinations and targeted therapies.

13. Prepare written primary or secondary review, which requires the assessment of Clinical Pharmacology studies, including identifying deficiencies, and providing recommendations.

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

15. Prepare the results of analysis and evaluations, define problems, and identifies deficiencies and state conclusions.

16. Represent an organization in dealing and negotiating with Federal agencies, State, local and foreign governments, industry professional organizations and public interest groups.

17. Respond to inquiries on scientific issues in Clinical Pharmacology including pharmacodynamics and personalized medicine.

18. Serve as an expert point of contact for an organization on external queries related to personalized medicine and targeted therapy.