The Food and Drug Administration (FDA) is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation. FDA also has responsibility for regulating manufacturing, marketing, and distribution of tobacco products to protect the public health.
The Center for Drug Evaluation and Research (CDER) is responsible for the regulation of all human and biosimilar pharmaceuticals. CDER develops FDA policy regarding the safety, effectiveness, and labeling of all drug products for human use; reviews and evaluates abbreviated new drug applications (ANDAs), investigational new drug applications (INDs), and biologics license applications (BLAs); develops and implements standards for the safety and effectiveness of all over-the-counter (OTC) drugs; monitors the quality of marketed drug products through product testing, surveillance, and compliance programs; coordinates activities involving biological drug products including research, compliance, and product review and approval.
The Office of Generic Drugs (OGD) is recruiting to fill the position of Deputy Director for Clinical and Regulatory Affairs, Office of Generic Drugs. OGD is responsible for the development and implementation of standards for the safety and effectiveness of generic drugs; reviews and evaluates Abbreviated New Drug Applications (ANDAs) and their amendments or supplements and determines approvability; establishes bioequivalence specifications for drug products and develops guidelines for bioequivalence reviews, industry protocols, and studies; and oversees all aspects of labeling submissions for ANDAs.
Major Duties and Responsibilities:
Serves as Deputy Director for Clinical and Regulatory Affairs, OGD and participates fully with the OGD Office Director in providing senior leadership to the subordinate Offices and other staffing functions within OGD, Immediate Office (IO). Provides senior level technical and administrative direction to three or more subordinate employees performing the work and functions of the organization.
Obtains resources and identifies strategic objectives for the organization.
Defines jobs, selects employees, and assigns work; defines technical work requirements and milestones; evaluates the organization and employee accomplishments by accepting or rejecting work products; and presents and defends organization and employees work to senior management and other offices.
Recommends employee promotions and recognition; approves leave; implements performance modifications and takes corrective actions as appropriate.
Provides employees resources and information that insures a safe and healthy work environment.
Acts with full authority in carrying out the variety of scientific, technical and administrative duties required of that position. Uses an understanding of all projects underway as well as an intimate understanding of major policy matters.
Provides technical direction and leadership to the OGD staff in the critical aspects of the pre and post- marketing initiative.
Directs and coordinates activities to develop support; secures and provides information concerning significant medical policies and decisions; presents conclusions and recommendations; develops courses of action and alternatives; and identifies and resolves actual or potential problems in medical programs or regulatory review products or process through cooperation and negotiation.
Provides technical direction and oversight for developing and implementing a comprehensive and effective plan to update the standard operating procedures (SOPs and MAPPS) and guidance to ensure effective communication of policies to OGD staff and drug development advice to external stakeholders.
Works in collaboration with the Director and fully participates in planning, managing, organizing, and directing all the regulatory review operations, program segments, functions, and activities of the Office including the formulation and establishment of Office policies and goals, determination of organizational and budget requirements, preparation of the budget, and allocation of Office resources necessary to accomplish the regulatory review mission of the Office.
Works in consultation with the Office Director and initiates decision making processes and documents and participates fully in discussions and decisions concerning Office plans, programs, and activities, both in strategic planning and in the actual determination, allocation, and administration of the Office program segment(s), functions, and activities.
Participates fully with the Director in the overall management of the Office with an emphasis on review quality and regulatory decision-making quality management systems. Establishes multi-directional communication methods and venues for OGD to enhance internal transparency and facilitate success in implementing quality systems.
Provides technical direction and leadership to the OGD staff in the critical aspects of the pre and post- marketing initiative. Provides oversight of OGD activities related to the implementation and meeting of GDUFA goals and oversight of review management activities to ensure a highly efficient and effective review process. Implements a quality system framework within OGD to enhance ongoing quality improvements initiatives.
Improves methods for auditing performance toward expected standards and develops plans for further improvement based on audit results. Facilitates the development of business requirements and systems for tracking and monitoring quality systems.
Serves as a principal agency advisor in the development and implementation of FDA policies and long-range objectives for medical programs and activities. Provides expert advice on medical programs plans and goals and the initiation, curtailment, consolidation, or decentralization of major medical projects and programs and legislative proposals for the FDA, CDER and immediate office.
Provides medical opinions on special and overall program problems which cross center lines and also where medical issues or aspects are critical or controversial. Identifies and evaluates medical programs and initiatives of other organizational components of DHHS, in academia, and in international organizations for potential use in the improvement of FDA programs and initiatives. Identifies and analyzes medical gaps and duplicative efforts within the Agency and in counterpart governmental agencies.
Provides authoritative advice, guidance, interpretations, and recommendations to senior Agency officials, program directors, scientific and professional personnel, Departmental representatives, intra-governmental counterparts, and others concerning FDA's medical policies, programs, and activities, such as assessing FDA's goals, objectives, and accomplishments and impact upon overall Agency medical policies.
Represents the Office as directed by Office Director in dealing and negotiating with individuals representing organizations such as other Federal agencies; State, local, and foreign governments.
Serves as a representative for the office with the regulated industry; professional and industry organizations; and public interest groups.
Represents the Office Director at meetings with medical, scientific, and professional groups within and outside the Federal government.
Carries out assigned duties in a manner consistent with the safety policies defined by the supervisor. Reports safety hazards, potentially hazardous situations, and close calls to the supervisor. Assists the supervisor to identify and eliminate un-safe conditions.
Performs other duties as assigned.
This position requires up to 25% travel.
Desired Experience and Qualifications:
At a minimum, the candidate must possess a doctoral-level degree from an accredited institution of higher learning, including: Ph.D., M.D., D.V.M., D.D.S., D.M.D., Sc.D., J.D, Pharm. D., or other research doctoral-degree widely recognized in U.S. academia as equivalent to a Ph.D.
Provides executive leadership to a 500+ multidisciplinary staff consisting of medical officers, pharmacists, pharmacologists, toxicologists, regulatory project managers, regulatory counsels, and support personnel.
Executive leadership experience with an established track record in leading drug development and knowledge of regulatory standards for safety and effectiveness of human drugs.
Effective communicator who can drive collaboration, empower staff, and is committed to the Public Health mission.
Silver Spring, MD (White Oak Campus)
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.
**First round cutoff date for applications is July 8, 2019. To ensure consideration, submit application prior to cutoff date. **
*U.S. Citizenship is required*
EthicsRequirements: 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 Disclosure Report (OGE 278) 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.
Securityand 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.
HowYou 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: 001
About The Food and Drug Administration
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. FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health. FDA also has
responsibility for regulating the manufacturing, marketing and distribution of tobacco products to protect the public
health and to reduce tobacco use by minors.
FDA also plays a significant role in the Nation’s counterterrorism capability. FDA fulfills this responsibility by ensuring
the security of the food supply and by fostering development of medical products to respond to deliberate and naturally
emerging public health threats.