Staff Fellow (Clinical Pharmacologist)
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The Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), Office of New Animal Drug Evaluation (ONADE), Division of Scientific Support (DSS) provides expertise, leadership, and coordination to all CVM offices regarding biostatistics, pharmacology, and environmental safety evaluations for reviews and research. Through our independent and collaborative reviews and evaluations, we support the Center's scientific and regulatory goals to approve safe and effective animal drugs.
Due to the immensity of its charge, CVM depends upon a diverse and dedicated workforce. We recognize the importance of multi-disciplinary teamwork in reaching superior and timely regulatory decisions therefore we foster an atmosphere where every employee's contribution is important. New concepts, ideas, and creative approaches to improve current operations and to meet existing and future challenges are encouraged. Our goal is to not only enable our employees to positively impact the Center today, but to prepare our workforce for the demands, responsibilities, and career opportunities of tomorrow. ONADE offers many benefits and operates in a hoteling work environment. Hoteling is an arrangement where employees reserve non-dedicated, non-permanent workspace at the Rockville duty station on an as-needed basis and as required, and telework when not at the Rockville duty station. ONADE provides the basic technology (e.g., laptop, monitors, webcam) needed to effectively work in the Rockville office and in a teleworking location. Hoteling, along with a strong telework program and strong electronic communication and workflow tools, affords employees in ONADE the flexibility to balance work/life demands while contributing to our high performing organization.
This position will be filled through FDA's Staff Fellowship program. The appointment is for two years with opportunities for renewal.
This is an Excepted Service position under Title 42. Applications will be accepted from all groups of qualified persons, including non-citizens. No previous Federal experience is required. This appointment does not confer any entitlement to conversion to a position in the competitive service and no entitlement to Merit Systems Protection Board (MSPB) appeals rights.
Additional selections may be made within the same geographical area FDA-wide.
- Not Required
Basic Qualification Requirements:
Possess a degree majoring in a 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.
GS-12: In addition to the basic qualification requirements and the minimum qualification requirements, you must meet the one year of specialized experience equivalent to the GS-11 in the Federal service, which includes participating in evaluating study designs, assay methodology, and sensitivity of the assay method of drug products and pharmacokinetics of chemical entities; performing pharmacokinetics & pharmacodynamics modeling and analysis utilizing software such as WinNonLin, NONMEN, or WinBUGS; and developing written summaries of bioavailability, bioequivalence, and pharmacokinetic studies. This experience must be reflected in your resume. Volunteer experience can be used as qualifying experience.
GS-13: In addition to the basic qualification requirements and the minimum qualification requirements, you must meet the one year of specialized equivalent to the GS-12 in the Federal service, which includes evaluating study designs, assay methodology, and sensitivity of the assay method of drug products and pharmacokinetics of chemical entities; performing pharmacokinetics & pharmacodynamics modeling and analysis utilizing software such as WinNonLin, NONMEM, or WinBUGS; and developing written summaries of bioavailability, bioequivalence, and pharmacokinetic studies. This experience must be reflected in your resume. Volunteer experience can be used as qualifying experience.
You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program. For further information, click on foreign education.
Conditions of Employment:
1. Security and Background Requirements: If not previously completed, a background security investigation will be required for all appointees. Appointment will be subject to the applicant's successful completion of a background security investigation and favorable adjudication. Failure to successfully meet these requirements may be grounds for appropriate personnel action. In addition, if hired, a background security reinvestigation or supplemental investigation may be required at a later time. Applicants are also advised that all information concerning qualifications is subject to investigation. False representation may be grounds for non-consideration, non-selection and/or appropriate disciplinary action.
2. E-Verify: If you are selected for this position, the documentation that you present for purposes of completing the Department of Homeland Security (DHS) Form I-9 will be verified through the DHS "E-Verify" System. Federal law requires DHS to use the E-Verify System to verify employment eligibility of all new hires, and as a condition of continued employment obligates the new hire to take affirmative steps to resolve any discrepancies identified by the system. The U.S. Department of Health and Human Services is an E-Verify Participant.
3. Direct Deposit: All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing.
4. Pre-employment physical required: No
5. Drug testing required: No
6. License required: No
7. Mobility agreement required: No
8. Moving expenses authorized: No
9. Immunization required: No
10. Relocation Incentive authorized: No
11. Recruitment Incentive authorized: No
12. Student loan repayment incentive authorized: No
13. Annual leave for non-federal service authorized: No
14. Bargaining Unit Position: Yes
15. Financial disclosure statement required: Yes
Please be advised that this position will be subject to FDA's strict prohibited financial interest regulation and therefore, may require the incumbent of this position to divest of certain financial interests. Applicants are strongly advised to seek additional information on this requirement from the FDA hiring official before accepting this position.
Q - Nonsensitive
As a Pharmacologist in the Division of Scientific Support, Clinical Pharmacology Team within the Division of Scientific Support in the Office of New Animal Drug Evaluation (ONADE), you will evaluate the absolute and relative bioavailability of a new animal drug/drug product and the pharmacokinetics (absorption, metabolism, distribution, and elimination) of new chemical entities. You will also analyze and interpret these scientific investigations, technical data, opinions, and related information, and make recommendations for Agency action regarding New Animal Drug Applications and Investigational New Drug submissions.