Clinical Pharmacologist (Team Lead)

The incumbent serves as the Clinical Pharmacologist (Team Lead) for the Office of Clinical Evaluation (OCE) within the Office of Therapeutic Products (OTP). This position reports to the OCE Office Director. The Clinical Pharmacologist (Team Lead) provides secondary reviews (and infrequently primary reviews) of the results of submissions and applications requesting FDA regulatory consideration of clinical research, testing and manufacture of human drugs and any other related regulatory submissions. The incumbent serves as a resource to team members and make recommendations pertaining to clinical pharmacology studies in the therapeutic area for which the reviewer is responsible for scientific validity and for potential influence on organizational objectives and program goals of the Division, Office or Center.

Specifically, the Clinical Pharmacologist (Team Lead) will: Lead clinical pharmacology reviews to include assigning and evaluating work of team members on a regular and recurring basis. Perform regulatory review responsibilities that may include, but are not limited to, coordinating the review of INDs, IDEs, BLAs and their amendments and supplements, PMAs, 510(k)s), and product labeling. Assure that scientific reviews of regulatory submissions such as INDs, IDEs, BLAs, etc. are incorporated into a final assessment addressing all key aspects of the product(s) and proposed clinical trials. Provide authoritative advice to sponsors on such matters as, the design of clinical studies as it related to Clinical Pharmacology for products regulated by OTP. Make recommendations, both verbally and written, on initiative product development programs for OTP regulated medical products. Serve as a Clinical Pharmacology spokesperson on behalf of OCE and recognized authoritative source of information on matters related to the development of new regulations and guidance documents pertinent to cell and gene therapy, plasma protein therapeutics and other OTP regulated medical products. Serve as an authoritative scientific expert that is sought by peers with respect to issues related to these products manufacturing, characterization, specification, and safety testing, and as to the adequacy of design, implementation, and analysis of clinical trials.

Basic Qualification Requirements: In order to qualify for this Title 21 (Cures) position, the candidate(s) must meet the following requirements:

Education:

• Degree: biological sciences, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position. OR
• Combination of education and experience: Courses equivalent to a major, as shown in A above, plus appropriate experience or additional education.

Desired Professional Experience/Qualifications: The experiences and qualifications listed below are considered preferable/desired. Candidates who do not meet the “desired” criteria will not be excluded from consideration for this position. Ideal candidates should have a Doctorate or a Ph.D. in a biological, medical, veterinary, pharmacology, or physical science field. Experience assessing, analyzing or evaluating study designs, data or conclusions submitted by sponsors of pharmacology or biopharmaceutics submissions associated with IND, NDAs and BLAs to support marketing of a drug. Experience serving as a recognized authority in a specific therapeutic area to resolve unique, far-reaching, and previously unsolved problems. Experience designing and recommending studies concerning specific drug issues. Thorough knowledge of the mission, goals structures, policies, functions, interrelationships, and activities of the Division and Office, and of those other Agency organizations related by function and mission in order to ensure that rapid advances in translational science such as quantitative clinical pharmacology and pharmacogenomics are incorporated into regulatory reviews. Clear written, oral, and visual communication skills to speak and write with clarity and tact to communicate findings, advocate positions, make formal presentations, convey information related to a wide range of pharmaceutical regulatory issues, and effectively interact with agency staff and stakeholders. If you are using education completed in foreign colleges or universities, see the Foreign Education section below for additional 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. For further information, visit the U.S. Department of Education website for Foreign Education Evaluation. How you will be evaluated: You will be evaluated for this job based on how well you meet the qualifications above. This is a Title 21 announcement: Traditional rating and ranking of applications, and veterans' preference does not apply to this vacancy. You will be evaluated against the basic qualifications and if found qualified, you will be referred to the Hiring Manager for consideration.

Equal Employment Opportunity: 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. Equal Employment Opportunity (EEO) for federal employees & job applicants. Reasonable Accommodation: 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 an accommodation to have an equal opportunity to apply for a job. An employee with a disability needs an accommodation to perform the essential job duties or to gain access to the workplace. An employee with a disability needs an 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.