This Direct-Hire position is in the Food and Drug Administration, Center for Biologics Evaluation and Research (CBER), Office of Tissues and Advanced Therapies (OTAT), Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), in White Oak, MD. 

Note: Salary figures shown represent the OPM General Schedule Base Salary. Candidates may be eligible to receive Title 38 Physician and Dentist Pay (PDP), in addition to the regular General Schedule base salary. 

Summary:

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 safe, and effective. 

Do you want to join an organization that truly makes a difference? Be part of the development of cutting-edge technology? Do you want to stand at the forefront of an agency that manages the clinical trials of preventative vaccines, including the Covid-19 vaccine? If so, join CBER, a cutting-edge agency whose mission is to ensure the safety, purity, potency, and effectiveness of biological products including vaccines, allergenics, blood and blood products, and cells, tissues, and gene therapies for the prevention, diagnosis, and treatment of human diseases, conditions, and/or injuries. As part of our mission, we also seek to protect the public against the threats of emerging infectious diseases and bioterrorism. The Office of Tissues and Advanced Therapies (OTAT) does this by ensuring the safety, potency, effectiveness of a variety of products, including purified and recombinant therapeutic proteins for hematology, cellular therapies, gene therapies, and tissue products for the prevention, diagnosis, and treatment of human disease. 

This program oversees and provides guidance on product development programs through all phases of product development for products under the program’s jurisdiction. The program decisions impact FDA and CBER’s mission to protect and advance public health. We are looking for a candidate who would be responsible for managing and directing a professional regulatory review program, a major activity of the regulatory review Office/Division.  

Qualifications: 

• Doctor of Medicine, Doctor of Osteopathic Medicine or equivalent  
• A current, active, full, and unrestricted license or registration as a Physician 
• Must have five years of graduate training and experience in hematological disorders and non-malignant hematology  
• Graduate training (1-year internship, residency, and fellowship) 
• Board certification in Hematology/Oncology preferred  

Duties:

• 40% - Work with other FDA centers and agencies on consultative and collaborative reviews. Develop policy and/or research regarding clinical issues, such as trial design issues and safety.  
• 30% - Obtain resources and identify strategic objectives for the organization. Supervise occupational specific tasks and provide technical administrative direction to subordinate employees performing the work and functions of the organization.  
• 30% - Provides guidance to sponsors regarding all phases of clinical development. Direct the clinical review program, which includes evaluating clinical data and protocols that involve biological products for the treatment of hematological disorders.  
• Perform other duties as assigned 
• The position requires up to 25% travel 

Responsibilities:

• The incumbent will be responsible for managing and supervising staff and overseeing work focused on the Nonmalignant Hematology functional area. 
• Develops policy and/or research regarding clinical issues, such as trial design issues and safety. Oversees the development of written policies and identifies critical problems in clinical trial methodology. 
• Directs the clinical review program in evaluating clinical data and protocols that involve biological products, especially cell and gene therapies, plasma derived products and devices, for the treatment of hematologic disorders. 
• Evaluates organizational and employee accomplishments by accepting or rejecting work products; presents and defends organizational impact and employees work products to senior management and other offices. 
• Recommends employee promotions and recognition; approves leave requests; implements performance modifications and takes corrective actions as appropriate. 

Working at the FDA:

Working at FDA means applying a passion for meaningful work with intellectual rigor to help solve the leading issues of our day. Smart, compassionate, innovative, and committed, the employees of the FDA tackle unprecedented challenges to protect and advance public health by helping to speed innovations that provide our nation with safe and effective medical products and that keep our food safe and reduce harm from all regulated tobacco products. We believe in collaboration, mutual respect, open communication, and opportunity for growth. If you are seeking to make a difference in the world, visit Jobs and Training at FDA | FDA to find your next career.

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.