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.
Post : Pharmacologist / Toxicologist
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.
Location(s) : Silver Spring, MD
Work Schedule : Full-Time
Cures Band(s) : Band C
Salary : USD 117,962 - USD 185,346
Full Performance Band Level : Band C
Travel Requirements : 25% or less
Bargaining Unit : 3591
Series : AD-0405/ AD-0415
Relocation Expenses Reimbursement : You may qualify for reimbursement of relocation expenses in accordance with agency policy.
Duties / Responsibilities
As a Pharmacologist/Toxicologist, the incumbent is responsible for reviewing and evaluating drug applications and communicating 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: (1) mechanism of action (MOA) as proof-of-activity for use of medicinal products in patients, and (2) safety of medicinal products for use in patients and healthy subjects.
• Uses non-clinical data to recommend a first-in-human (FIH)dose range that is safe within the clinical trial context and therapeutic in patients. Employs advanced scientific knowledge for human dose selection that integrates medicinal products' pharmacology, molecular and cellular biology. Mathematical modeling maybe employed for human dose selection, as needed.
• Evaluates whether non-clinical sections of product labeling have accurate and adequate information to communicate the safety and risks of use to patients. Information in the product labeling to be evaluated include, but are not limited to, genotoxicity, carcinogenicity, and reproductive safety (fertility, embryofetal, and postnatal development) of the drug, and duration of contraception where applicable. Collaborates with other Divisions or Offices and Centers, as appropriate.
Conditions of Employment
• U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
• Employment is subject to the successful completion of a background investigation, verification of qualifications, completion of onboarding forms, submission of required documents, and any other job-related requirement before or after appointment.
• Applicants must meet all qualification requirements by the closing date of this announcement.
• Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice.
• FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the matter.
• Males born after December 31, 1959, must be registered with the Selective Service.
• One-year probationary period may be required.
• Financial Disclosure may be required.
• Ethics Clearance may be required.
• Background Investigation/Security Clearance is required. All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time.
Qualifications
To be placed into a Cures position, candidates must meet the following criteria :
1. Scientific, Technical, and Professional Fields
2. Qualified and Outstanding Candidates
a. 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.
b. 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 :
Pharmacologist, AD-0405 Series : A bachelor’s degree or higher in toxicology, pharmacology, pharmaceutics, environmental sciences, medicinal chemistry, pharmaceutical sciences, or related sciences. The degree must be from an accredited program or institution.
Toxicologist, AD-0415 Series : A bachelor’s degree or higher in toxicology, pharmacology, pharmaceutics, environmental sciences, medicinal chemistry, pharmaceutical sciences, or related sciences. The degree must be from an accredited program or institution. Desired Professional Experience : Our ideal candidate will possess experience in molecular, cellular or systems biology, pharmacology, and toxicology.
Desired Education : Our ideal candidate will possess a doctorate degree and specialized experience in neuroscience, immunology, pathology, cancer/molecular biology, or ophthalmology from an accredited 4 university are highly encouraged to apply.
Education Transcripts
SUBMITTING YOUR TRANSCRIPTS : Positions which are scientific or technical in nature often have very specific educational requirements. A transcript is required to verify educational achievement. Pay careful attention to the Qualifications and Education sections to identify vacancies where a transcript is required. Even if you hold a similar position or are a current FDA employee, you are not exempt from transcript requirements.
FOREIGN EDUCATION : 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; or full credit has been given for the courses at a U.S. accredited college or university.
Security Clearance Requirements Background Investigation/Security Clearance Requirements: Non-Sensitive/Moderate Risk 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 investigation or supplemental investigation may be required later. Applicants are also advised that all information concerning qualifications is subject to investigation. False representation may be grounds for non-selection and/or appropriate disciplinary action.
Reasonable Accommodation
Reasonable Accommodation Policy Federal agencies must provide reasonable accommodation to applicants with disabilities where appropriate. Applicants requiring reasonable accommodation for any part of the application process should follow the instructions in the job opportunity announcement. For any part of the remaining hiring process, applicants should contact the hiring agency directly. Determinations on requests for reasonable accommodation will be made on a case-by-case basis. A reasonable accommodation is any change to a job, the work environment, or the way things are usually done that enables an individual with a disability to apply for a job, perform job duties or receive equal access to job benefits.
Under the Rehabilitation Act of 1973, federal agencies must provide reasonable accommodations when : An applicant with a disability needs accommodation to have an equal opportunity to apply for a job. An employee with a disability needs accommodation to perform the essential job duties or to gain access to the workplace. An employee with a disability needs accommodation to receive equal access to benefits, such as details, training, and office- sponsored events. You can request a reasonable accommodation at any time during the application or hiring process or while on the job. Requests are considered on a case-by-case basis. Learn more about disability employment and reasonable accommodations or how to contact an agency.
E-Verify
The Food and Drug Administration participates in the USCIS Electronic Employment Eligibility Verification Program (E-Verify). E-Verify helps employers determine employment eligibility of new hires and the validity of their Social Security numbers.
How to Apply
Submit resume or curriculum vitae with cover letter by October 11, 2024, to CDER- ONDPharmTox.Employment@fda.hhs.gov. Candidate resumes may be shared with hiring officials 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: 24-046LIN on the email subject line.
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