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FDA
About the job
This position is being filled under a stream-lined hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of the authority. Additional information on 21st Century Cures Act can be found here: https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act
View full vacancy announcement here:
Application Period: September 14, 2022 – October 14, 2022
Area of Consideration: United States Citizenship is required. You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration.
Position: Interdisciplinary Scientist
Series: AD-0401, 0405, 0415
Location(s): Silver Spring, Maryland
Work Schedule: Full Time
Salary: Starting at: $106,823
Cures Band(s): Band C
Full Performance Band Level: Band C
Travel Requirements: Less than 25%
Bargaining Unit: 3591
Relocation Expenses Reimbursement: You may qualify for reimbursement of relocation expenses in accordance with agency policy.
Introduction
The Food and Drug Administration (FDA) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices are safe, and effective.
The mission of the Center for Drug Evaluation and Research (CDER) is to perform an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. CDER regulates over the counter (OTC) and prescription drugs, including biological therapeutics and generic drugs.
The Office of New Drugs’s (OND) public health mission is to protect and enhance the health of the public through the review and evaluation of scientific data submitted by pharmaceutical manufacturers in support of both New Drug (NDA) and Investigational New Drug applications (INDAs), and to determine if candidate drugs are safe and effective.
Duties/Responsibilities
As an Interdisciplinary Scientist, the incumbent is responsible for reviewing and evaluating drug applications and communicates conclusions with a multidisciplinary review team. The work will be performed within any of the pharmacology/toxicology or clinical drug review divisions located within OND.
• Reviews nonclinical data and communicates safety findings, evaluates nonclinical sections of product labeling, makes regulatory recommendations, and meets with industry representatives.
• Serves as a CDER resource for nonclinical safety assessments participating in work groups or subcommittees.
• reviews in silico, in vitro, ex-vivo and animal data submitted to IND Applications, NDAs, and Biological License Applications (BLAs) to evaluate
o (1) mechanism of action (MOA) as proof-of-activity for use of medicinal products in patients, and
o (2) safety of medicinal products for use in patients and healthy subjects.
Supervisory Responsibilities: None
Qualifications
To be placed into a Cures position, candidates must meet the following criteria:
- Scientific, Technical, and Professional Fields
- Qualified and Outstanding Candidates
- Qualified applies to all candidates for Cures appointments. The FDA OTS will use the basic requirements defined in the OPM Qualification Standards as a baseline for comparing experience levels and other candidate attributes for relevant positions.
- Outstanding candidates can be defined by existing outstanding work experience, outstanding performance rating, or both.
To qualify for this Title 21 Cures position, the candidate(s) must meet the following required qualifications. Please note: Additional education and experience listed that is not indicated as required is preferable and desired. Candidates who do not meet the “desired” criteria will not be excluded from consideration for this position.
Education Requirement:
General Natural Resources Management and Biological Sciences Series, 0401
Pharmacology Series, 0405
Toxicology Series, 0415
Desired Professional Experience:
Our ideal candidate will possess experience in molecular, cellular or systems biology, pharmacology, and toxicology.
How to Apply
Submit resume or curriculum vitae with cover letter by October 14, 2022, to CDER-ONDPharmTox.Employment @fda.hhs.gov. Candidate resumes may be shared with hiring official within the Center for Drug Evaluation and Research with a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not share”. Please reference Job Reference Source Code ID: 22-067LIN in the subject line.
Announcement Contact
For questions regarding this Cures position, please contact Sharon Miller, [email protected]
The United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor. Federal agencies must provide reasonable accommodation to applicants with disabilities where appropriate.
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