Biologics, Quality/Risk Management, Regulatory Compliance, Research & Development
The Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) located at the Food and Drug Administration (FDA) in Silver Spring, MD is recruiting to fill the position of Director, Office of Bioequivalence (OB). FDA is a Federal scientific, regulatory, and law enforcement agency with the statutory responsibility to promote and protect the health of the American public. FDA’s programs are national in scope and effect, and its activities directly affect and heavily impact multi-billion-dollar industries and every American.
CDER is responsible for regulating prescription drugs, including new drugs, generic drugs, biological products and biosimilars as well as over-the-counter drugs. CDER’s drug regulatory responsibilities include premarket review of new drugs and generic drugs; maintenance of the OTC drug monograph system; monitoring of all marketed drug safety and promotional activities; review, monitoring and enforcement of drug quality during the entire drug life cycle; and ensuring drug products in the market comply with the law.
The Office of Bioequivalence (OB) oversees the thorough evaluation of any clinical data required to support Abbreviated New Drug Application (ANDAs) and develops medical judgment. OB establishes bioequivalence specifications for drug products and develops guidelines for bioequivalence reviews, industry protocols, and studies. OB supports the development and implementation of standards for the safety and effectiveness of generic drugs.
Plans, manages, organizes, and directs all the regulatory review operations, program segment(s), functions, and activities of OB as carried out by Division Directors, Deputy Directors, subordinate supervisors and/or team leaders and a highly trained and skilled staff of professionals responsible for the regulatory review mission of the Office.
Applies knowledge of administrative and program management principles and skills to carrying out the mission of the Office as well as to address and solve unusual and often precedent setting problems associated with the regulatory review program segment(s). Seeks and develops the most cost effective and fiscally responsible methods to conduct these program segment(s) and to solve these problems.
Initiates decision-making processes and documents and participates fully in discussions and decisions concerning Office and OGD plans, programs, and activities, both in strategic planning and in the actual determination, allocation, and administration of Office programs, functions, and activities. Provides authoritative advice and assessments of the impact of actual and proposed Administration or Congressional actions on the programs, functions, and activities of the Office and how they interrelate to CDER activities and priorities.
Develops and implements OB and its Division policies and plans and makes critical decisions and provides expert advice and counsel concerning approaches and options that are sound and feasible in relation to Office and OGD goals and objectives and Federal budgetary and economic realities. Continually evaluates budget, fiscal, and administrative controls to manage Division program segment(s) and services. Develops and makes recommendations for the enhancement and improvement of the mission and functions of the Office.
Represents the Office and OGD in dealing and negotiating within CDER and with individuals representing organizations such as the Congress; other Federal agencies; State, local, and foreign governments; the regulated industry; professional and industry organizations; and public interest groups. Directs the preparation, clearance, and finalization of Office responses to inquiries covering all aspects of the programs, functions, and activities of the Office.
Directs the preparation of analyses of the impact of proposed changes to Agency laws and regulations which affect the functions, program segment(s), and activities of the Office. Decides on changes and additions to the 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 implementation of new laws and regulations which impact on the mission of the Office. This includes responsibility for the initiation and implementation of new policies, systems, procedures, and organizational structures.
Provides occupational specific technical and administrative direction 25 percent or more of the time to three or more subordinate employees performing the work and functions of the organization.
The ideal candidate should have the following characteristics and qualifications:
Minimum Education Requirement: Meets the Office of Personnel Management (OPM) Individual Occupational Requirements (IOR) for General Medical and Health Series, 0601. Please review the entire IOR to confirm the minimum education requirements at the following link: General Medical and Healthcare Series, 0601
Executive leadership experience with an established track record in leading drug development and knowledge of regulatory standards for safety and effectiveness of human drugs.
Demonstrated management of organizations of significant size and complexity.
Effective communicator who can drive collaboration, empower staff, and is committed to the Public Health mission.
Silver Spring, MD (White Oak Campus)
Salary and Incentives:
Salary is commensurate with education and experience. Optional incentives may be authorized.
Area of Consideration:
Applications will be accepted from all qualified applicants.
All qualified candidates can submit curriculum vitae and cover letter in which you describe why you feel you are uniquely qualified for this position electronically to Whitney Flickinger, Whitney.Flickinger@fda.hhs.gov.
** Cutoff date for applications is October 14, 2019. To ensure consideration, submit application prior to cutoff date. **
Conditions of Employment:
*U.S. Citizenship is required*
Ethics Requirements: This position is subject to strict prohibited financial interest regulations which could restrict the type of financial interest (stock holdings) for the employee, the spouse, and minor children of the employee. Selectee for this position will be required to file a Confidential Financial Disclosure Report (OGE 450) and may require the selectee to obtain clearance from the FDA Division of Ethics and Integrity before a final offer can be made. For additional information on the prohibited financial interests, please visit the FDA Ethics and Integrity Office website at: http://www.fda.gov/AboutFDA/WorkingatFDA/Ethics/default.htm.
Security and Background Requirements: If not previously completed, a background security investigation will be required for all appointees. Appointment will be subject to the applicant’s successful completion of a background security investigation and favorable adjudication. Failure to successfully meet these requirements may be grounds for appropriate personnel action. In addition, if hired, a background security investigation or supplemental investigation may be required later.
Applicants are also advised that all information concerning qualification is subject to investigation. False representation may be grounds for non-selection and/or appropriate disciplinary action.
EEO Responsibility: The incumbent is responsible for furthering the goals of equal employment opportunity (EEO) by taking positive steps to assure the accomplishment of affirmative action objectives and by adhering to non-discriminatory employee practices in regard to race, color, religion, sex, national origin, age, or handicap. Specifically, as a manager, incumbent initiates non- discriminatory practices and affirmative action for the area under his/her supervision in the following: 1) merit promotion of
employees and recruitment and hiring of applications; 2) fair treatment of all employees; 3) encouragement and recognition of employee achievements; 4) career development of employees; 5) full utilization of their skills.
Reasonable Accommodation Policy: Federal agencies must provide reasonable accommodation to applicants with disabilities where appropriate. Applicants requiring reasonable accommodation for any part of the application process should follow the instructions in the job opportunity announcement. For any part of the remaining hiring process, applicants should contact the hiring agency directly.
Determinations on requests for reasonable accommodation will be made on a case-by-case basis.
How You Will Be Evaluated:
A review of your resume and supporting documentation will be made to determine if you are qualified for this job based on how well you meet the desired qualifications above. If you are referred to the hiring manager for consideration, you may be further evaluated based on an interview.
As a new or existing federal employee, you and your family may have access to a range of benefits. Your benefits depend on the type of position you have – whether you’re a permanent, part-time, temporary or an intermittent employee. You may be eligible for the following benefits, however, check with your agency to make sure you’re eligible under their policies. You can find information about each program at https://www.opm.gov.
Internal Number: 00123
About The Food and Drug Administration
FDA is an agency within the Department of Health and Human Services.
The FDA's organization consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods, Global Regulatory Operations and Policy, and Operations.
The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.
The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.