Application Period: 11/22/2024-12/06/2024

This is position is located in Rockville, Maryland.

Duties/Responsibilities
The Director, Office of Generic Animal Drugs (OGAD), is the principal advisor to the Center Director, Center for Veterinary Medicine (CVM), providing expert-level administrative, scientific, and regulatory authority for CVM on matters related to pre-market review of generic animal drugs. Assists the Center Director on security intelligence matters involving OGAD; accessing classified information in written and/or electronic formats and requiring Top Secret Clearance. The incumbent provides scientific, administrative, and regulatory leadership and direction through subordinate division directors for FDA's pre-market generic animal drug regulatory program activities. The Office Director oversees the work of the Office with specific duties as follows:
• Coordinates CVM’s regulatory pre-market generic animal drug review program to ensure the safety, effectiveness, and manufacturing quality of approved generic animal drugs. Specifically, is responsible for (a)review of organizational structure, functions, responsibilities and work assignments to assure the effective,efficient, and economical use of scientific, professional and technical staff; (b) evaluation of pre-market generic animal drug review policies and procedures to increase effectiveness, efficiencies and resource savings in program areas; (c) strategic planning to ensure alignment of the Office’s Strategic Plan with those of the Center, FDA, and HHS; and (d) oversight of the development of new regulations, policies, guidance and procedures impacting pre-market generic animal drug review program requirements.
• Serves as a nationally recognized authority, expert, and leader in regulatory and science policy aspects of premarket generic animal drug review and, as such, provides technical and regulatory guidance for the Office’s generic animal drug review programs. Provides authoritative advice and information on regulatory evaluation of generic animal drugs to the Center Director, other Government agencies and external organizations.
• Applies a broad knowledge of regulatory aspects of pre-market generic animal drug review and an intimate understanding of the provisions, limitations and practical applications of FDA’s enabling legislation and the Code of Federal Regulations. Reviews and evaluates project proposals and plans in terms of soundness of scientific, technical, legal reasoning, sufficiency of project proposals, relative priorities, availability of resources and anticipated results.
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Implements changes in structure that may be needed to meet shifts in program goals or to accomplish new requirements imposed by legislation and FDA policy or regulations. • Develops broad, complex programs that are critical to the organization. The incumbent directs the preparation of analyses of the impact of proposed changes to Agency laws and regulations which affect functions, program segment(s), and activities of the Office necessary to implement new legislation or regulations and develops various scenarios for dealing with expansion or contraction of Office functions, program segment(s), and activities. Directs the development and implementation of new laws, regulations, guidance, and policies which impact the mission of the Office to evaluate abbreviated new animal drug applications and ensure safety, effectiveness, and manufacturing quality of generic animal drugs.
• Provides technical and regulatory leadership to scientific/professional and support personnel engaged in executing FDA's broad national regulatory programs and activities as required by statute or FDA published regulations. This includes addressing and solving unusual and often precedent setting problems and assisting the regulatory review segments. Reviews and evaluates Center programs and activities associated with generic animal drug review in terms of achieving program goals and objectives and accomplishing legislated responsibilities.
• Represents the Office in dealings with other Federal agencies; State, local, and foreign governments; Congress; the regulated industry; professional and industry organizations; and public interest groups and in other matters dealing with Agency policy and programs as it relates to generic animal drugs. Builds and maintains collaborative network of scientists, regulators, and professionals who are internal and external to the FDA (e.g., other Federal Agencies, state-level governments, and/or others who share mutual concerns and/or regulatory responsibility for ensuring the safety, effectiveness, and quality of generic animal drugs.
• Manages resources to achieve the performance goals outlined within the Animal Generic Drug User Fee Act (AGDUFA).

Qualifications
To be placed into a Cures position, candidates must meet the following criteria:
1. Scientific, Technical, and Professional Fields
2. Qualified and Outstanding Candidates
a. Qualified applies to all candidates for Cures appointments. The FDA OTS will use the basic requirements defined in the OPM Qualification Standards as a baseline for comparing experience levels and other candidate attributes for relevant positions.
b. Outstanding candidates can be defined by existing outstanding work experience, outstanding performance rating, or both.
In order to qualify for this Title 21 Cures position, the candidate(s) must meet the following required qualifications. Please note: Additional education and experience listed that is not indicated as required is preferable and desired. Candidates who do not meet the “desired” criteria will not be excluded from consideration for this position.
Education Requirement:
Series: 0701
Degree:
Doctor of Veterinary Medicine (DVM) or equivalent degree, i.e., Veterinary Medical Doctor (VMD), obtained at a school or college of veterinary medicine accredited by the American Veterinary Medical Association Council on Education (AVMA). The AVMA web site, http://www.avma.org(external link), has a listing of all AVMA-accredited veterinary medical schools.
OR
Graduates of foreign veterinary medical schools that are not accredited by the AVMA Council on Education (Refer to AVMA web site, http://www.avma.org (external link) for information.
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Series: 0401
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.
For more information please see: OPM Occupational Series Qualification Requirements
Desired Professional Experience:
• Advanced education, such as D.V.M., Ph.D., M.S. and/or board certification in relevant scientific discipline is encouraged.
• Knowledge of and experience working with federal regulatory programs and the Federal Food, Drug, and Cosmetic (FD&C) Act.
• Knowledge and experience in FDA regulatory standards and an understanding of the laws and regulations pertinent to the generic new animal drug approval process.
• Experience with the conduct of laboratory research and application of the scientific method approach to conducting and evaluating experiments.
• Demonstrated ability to develop networks and build alliances; collaborates across boundaries to build strategic relationships and achieve common goals.
• Demonstrated leadership skills in championing values that includes but not limited to honesty and integrity, creativity and innovation, commitment and accountability, delegation, and empowerment, and fully embracing a vision and purpose of the organization in leading a highly technical team.
• Communicator who can drive collaboration and teamwork, empower staff, and is committed to CVM/FDA’s Public Health mission of protecting human and animal health; and has skill in written and verbal communications to prepare written documents and findings and to present finding and conduct briefings.
• Demonstrated skill in identifying and analyzing problems; generating alternative solutions and make recommendations.