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.
Duties:The incumbent serves as the Director for the Division of Clinical Evaluation Hematology (DCEH) within the Office of Clinical Evaluation (OCE) under the Office of Therapeutic Products (OTP) and manages daily operations of the Division. This position reports to the Director of OCE. OTP is a newly established Super Office within CBER which is responsible for the continued safety, purity, potency, and effectiveness of cellular, tissue, and gene therapies, plasma protein therapeutics, and other products regulated by OTP. The incumbent serves as Division Director, DCEH, and ensures the safety and effectiveness of biological therapies or devices regulated by OTP used in the prevention, treatment, and mitigation of disease.
The Director manages daily operations of the Division and regularly serves as a close advisor to the OCE Director and Deputy Office Director. The incumbent is responsible for fully implementing the requirements of specific Equal Employment Opportunity, Food and Drug Administration (FDA), and Department of Health and Human Services (HHS) programs. The incumbent additionally carries out and supports other special HR programs of the Federal Government, HHS, and FDA as needed.
Specifically, the Division Director will:
Serve as the Director and supervise staff and oversee work focused on malignant and nonmalignant hematologic disorders.Oversee policy and/or research regarding hematology related clinical issues, such as trial design issues and safety; and oversee the development of written policies, identify critical problems in clinical trial methodology.Oversee 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.Provide guidance to sponsors regarding all phases of clinical development. Oversee in developing hematology related clinical guidelines and procedures.Direct BLA review committee or the review committee for the medical device marketing application for marketing of biological therapies or devices regulated by OTP based on application of policy and standards to the safety and effectiveness of the therapies.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.
Salary: Starting at $210,000 and is set to commensurate with education and experience.
View further requirements of this position and apply by 20 December.
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