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The position is located in the Food and Drug Administration (FDA), Office of Foods and Veterinary Medicine (OFVM), Center for Veterinary Medicine (CVM), Office of New Animal Drug Evaluation. The Office of New Animal Drug Evaluation (ONADE) evaluates the safety, effectiveness and quality of new animal drugs, including pharmaceutical dosage form products, products intended for use in animal feed, as well as a variety of newly emerging technologies. Among the issues evaluated include, the safety of food derived from animals administered new animal drugs and the impacts on the environment from the Agency's action to approve a new animal drug.
The Director, ONADE, holds a key executive leadership position in CVM and, as a senior science/regulatory manager, is responsible for evaluating the safety, effectiveness and quality of new animal drugs.
The Director, ONADE assists the Director, CVM, in the formulation, development and execution of short and long range goals to address public health issues and to increase the availability of safe, effective and quality new animal drugs, both domestically and internationally.
Serves as a member of the Center's Executive Board which is responsible for CVM's overall strategic direction including adherence to a shared mission and vision as well as organizational development and improvement.
Provides science policy leadership and direction (through subordinate division directors) for a staff of approximately 250 scientific and support personnel engaged primarily in the pre-approval evaluation of the safety, effectiveness and quality of new animal drugs.
Identifies, defines and develops scientific and regulatory policies necessary to implement performance standards to meet industry, statutory and public expectations of the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA).
Represents the Office and establishes and maintains effective relationships in meetings and conferences with top level FDA and Department officials, national/international industry representatives, Members of Congress and counterparts from other academic organizations, animal producer and veterinary groups, and others.
Occasional travel - You may be expected to travel for this position.