Summary: 

The Food and Drug Administration is the regulatory, scientific, public health, and consumer protection agency responsible for ensuring that all human and animal drugs, and medical devices are safe and effective; that cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, and radiation emitting devices are safe; and that all such products marketed in the U.S. are adequately, truthfully and informatively labeled and safely and properly stored, transported, manufactured packaged and regulated. 

The mission of the Center for Biologics Evaluation and Research (CBER) is to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies.

You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration. This is a 21st Century Cures Act authority announcement. Traditional federal rules regarding rating, ranking, and veterans' preference do not apply. 

Note: Incentives may be authorized; however, this is contingent upon funds availability. If authorized, certain incentives will require you to sign a service agreement to remain in the Federal government for a period of up to 3 years. Note: This statement does not imply nor guarantee an incentive will be offered and paid. Incentives include the following: moving expenses, recruitment, or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed military service, etc.   

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 this authority. 

Additional information on 21st Century Cures Act can be found here: 

21st Century Cures Act Information 

Duties: 

The incumbent serves as the Artificial Intelligence Specialist in the Immediate Office of the Director (IOD) of the Office of Regulatory Operations (ORO). This position reports to the ORO Office Director. The AI Specialist leads and coordinates CBERs efforts in Artificial Intelligence to support and ensure CBER’s regulatory, review, scientific, and administrative needs are met. 

Specifically, the AI Specialist will:  

• Define and execute the AI strategy and roadmap for CBER in alignment with FDA. 
• Review and analyze AI policy, guidance, and legislative proposals. 
• Serve as a technical, scientific consultant and advisor to CBER Leadership. 
• Provide expertise and consultation to CBER staff on scientific and regulatory aspects of artificial intelligence. 
• Collaborate with business stakeholders, IT teams, and external partners to understand business problems, define the AI requirements, identify, and facilitate AI solutions. 
• Establish and oversee AI governance, policies, and standards, ensuring the quality, security, ethics, and compliance of CBER AI solutions. 
• Research and evaluate the latest AI trends, technologies, and best practices, and recommends application to the organization's AI initiatives. 
• Coordinate and develop training in support of AI including responsibilities listed above. 
• Present Center’s activities and policies to national organizations, government agencies, state and local governments, industry, academia, consumer organizations, Congress, and/or the scientific community. 

How to Apply: 

Please submit electronic resume or curriculum vitae (for each position held, please be sure to clearly define the number of years by month and year, all completed trainings, and clearly describe duties and accomplishments). Please also submit SF50 (if applicable), latest PMAP (if applicable), unofficial transcripts, Foreign Credit Evaluation (if applicable), and letter of interest (Word or PDF) with “Title 21 CBER/ORO/IOD AI Specialist” in the subject line to: CBERHumanCapital@fda.hhs.gov. Applications will be accepted through 12/17/2024. 

Announcement Contact: 

For questions regarding this Title 21 (Cures) position, please contact CBERHumanCapital@fda.hhs.gov.  

The Department of Health and Human Services is an equal opportunity employer with a smoke-free environment. 

FDA is an equal opportunity employer.