Supervisory Interdisciplinary Scientist


Vacancy ID: 827669   Announcement Number: HHS-FDA-CDER-MP-13-827669   USAJOBS Control Number: 335912500

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 827669
1. Title of Job

Supervisory Interdisciplinary Scientist
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 an ICTAP Eligible?

For information on how to apply as an ICTAP eligible see http://opm.gov/rif/employee_guides/career_transition.asp#ictap.  To be well-qualified and exercise selection priority for this vacancy, displaced Federal employees must be rated at 85.0 or above on the rating criteria for this position.


Are you eligible for Indian preference as defined by the Department of the Interior (DOI) and as evidenced by appropriate Bureau of Indian Affairs (BIA) authorized certification?


Are you eligible for preference based on being a Public Law 94-437 Indian Health Service Scholarship recipient? For more information, please click here.    


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


Are you a PHS Commissioned Officer (This includes active duty officers, inactive reserve officers, and applicants who have been approved for commissioning in the USPHS Commissioned Corps)?


Are you eligible for noncompetitive appointment?
This includes applicants who are eligible for special or noncompetitive appointment authorities such as 30% or more compensable disabled veterans, persons with disabilities and PHS Commissioned Corps Officers.  This also includes applicants who meet the qualifications for this position and who have previously held, or currently hold, a Federal position at the grade of this position.


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 Toxicologist

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:


240000031 Montgomery County, MD

22. Transition Assistance Plan

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 description below, select the one which best describes your
education and meets the Basic Qualification Requirements for Pharmacologist,
GS-405:

A. Degree: major 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. Evaluation of Education: The positions in this series are multidisciplinary positions, since the work involves the application of a scientific knowledge of biochemistry, physiology, pharmacology, and such related sciences as microbiology, biophysics, genetics, mathematics, and statistics. 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. Under some circumstances, i.e., where the course work provided additional insight into the biophysical, biochemical, and physiological relationships involved, courses in such subjects as cytology, embryology, cellular or microbial genetics, and biophysics may be used to meet this requirement. 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 have a combination of education and experience - courses equivalent to a major, as shown in A above, plus appropriate experience or additional education.
C. I do not possess the education and/or experience described above.

2. From the description below, select the one which best describes your education and meets the Basic Qualification Requirements for Toxicologist, GS-415:

A. Degree: 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. Evaluation of Education: The positions in this series are multidisciplinary positions because the work may involve the application of a scientific knowledge of anatomy, chemistry, biochemistry, physiology, pathology, toxicology, and related sciences musch as microbiology, biophysics, entomology, genetics, mathematics, and statistics.
B. I have a combination of education and experience- courses equivalent to a major, plus appropriate experience or additional education.
C. I do not possess the education and/or experience described above.

3. To qualify for the GS-15, in addition to the basic education requirement, you must have one year specialized experience equivalent to the next lower grade level in the Federal service.  Specialized experience is experience that has equipped the applicant with the particular knowledge, skills, and abilities to perform successfully the duties of the position, and that is typically in or related to the work of the position to be filled and can be demonstrated through skill with a regulatory area of expertise and knowledge of one or more professional fields (e.g Pharmacology, chemistry, biology, microbiology or pharmacy) and skill sufficient to identify and understand the most difficult, complex, and broad Agency regulatory issues; experience interpreting, evaluating and explaining  pharmacological/toxicological data/regulations and polices. Interdisciplinary positions are classified to be specific series which have been determined to be appropriate for the vacancy based on the duties and responsibilities of the positions and general qualifications to perform the work.

A. Yes, I have one year of specialized experience described above equivalent to the next lowergrade level, in the Federal service.
B. No, I do not possess the one year specialized experience for this position.

4. Are you a current career or career conditional  employee within Office of New Drugs (OND)

A. Yes, I am current Office of New Drugs (OND)
B. No, I am not a current competitive status employee.

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. Review and evaluate scientific submissions focusing on the toxicological otential of drugs in support of proposed clinical studies or proposed dosage regimes in the labeling.

6. Review and evaluate the results of non-clinical pharmacological and toxicological studies submitted by the drug sponsor/applicant in support of drug applications, supplements and other related scientific submissions to assess the safety of the drug.

7. Serve as a CDER/Agency resource for information on current concepts in pharmacology and toxicology, participating in professional committees and working groups both within and outside of CDER and FDA.

8. Plans work to be performed by subordinate members, sets and adjust both short term and long-term priorities, and prepare schedules for completion of work.

9. Assigns work to subordinates bases on priorities, selective consideration of the difficulty and requirements of the assignments, and the capabilities of employees

10. Develops performance standards

11. Interact with industry representative on the exchange of information and the provision of guidance regarding aspects of the application, notice, amendment, supplement or report.

12. Prepares comprehensive summaries and integrated discussions of data submitted for review.

13. Provide comments on labeling as it pertains to animal studies and probable safety in use of the drug for the proposed indications and at the recommended dosage.

14. Hear and resolve complaints from employees referring more serious unresolved complaints to a higher-level manager or supervisor.

15. Interview candidates for positions in the Division and recommend the appointment, promotion or reassignment to such positions.

16. Provide comments on labeling as it pertains to animal studies and probable safety in use of the drug for the proposed indications and at the recommended dosage.