Deputy Center Director

Summary

This position is being filled under a stream-lined hiring authority, Title 21 of the United States Code (21 US Code 379d-3a) as amended by the 21st Century Cures Act of 2016, section 3072 and the Consolidated Appropriations Act of 2023, Section 3624. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority. This position is being recruited based on the Title 21 Pay Table 4, Band H.

Duties

• As the Deputy Center Director, participates fully with the Center Director in planning, managing, organizing, and directing all operations, programs segments, functions, and activities of the Center.
• Represents the Center Director and serves as the Acting Center Director in his or her absence.
• Serves to organize and coordinate matters brought to the attention of the Office of the Center Director and acts as an advisor to the Center Director on issues requiring decisions based upon comprehensive reviews of the issues.
• Acts as a principal policy advisor to the Center Director on issues that require the most careful analysis concerning strategic initiatives and regulatory policy programs for CBER.
• Establishes and maintains effective Center-wide governance and clearance mechanisms for advancing policymaking within the CBER and in collaboration with other FDA Centers and Offices.
• Participates with the Office Directors in monitoring policy development and policy implementation activities of interest to the Center Director. Evaluates Center-wide ongoing biological product policies.
• Develops, prepares, and presents authoritative memoranda, briefings, position papers and other materials concerning substantive questions, issues, findings, conclusions and proposed solutions and suggested courses of action.
• Collaborates with the Center Director and Agency leaders to develop policy on pre-market product access and approvals, labeling, exclusivity and incentives, and emerging biological technologies and tools, including for cross-Center coordination.
• Directs special studies and workgroups on major issues, reviewing and evaluating Center programs and consulting with Agency officials to address problems with regional, national, and international impact, and recommending actions to resolve them.
• Provides authoritative guidance to leadership on short- and long-term activities to maximize CBER’s public health impact; reviews and analyzes program reports, proposals, memoranda, and other materials affecting Center operations.
• Shares responsibility with the Center Director to identify opportunities, develop strategies, and cross-Center projects. Oversees improvements in governance, hiring, and strategic planning while building strong coalitions.
• Leads the Center’s strategic engagement on legislative issues, representing the Center with Congress and stakeholders, guiding positions on legislation, and developing implementation plans following enactment of new laws.

Education

Pay careful attention to the Qualifications and Education sections to identify vacancies where a transcript is required. Even if you hold a similar position or are a current employee, you are not exempt from transcript requirements. Education Requirement: Bachelor's or graduate/higher level degree: major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position. TRANSCRIPTS: Positions which are scientific or technical in nature often have very specific educational requirements. You must submit an official transcript, unofficial transcript, including courses, grades earned, completion dates, and quarter and semester hours earned. Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education. If you are using education completed in foreign colleges or universities, see the Foreign Education section below for additional requirements. Electronic Transcript Caution: If you have obtained your transcripts electronically, the file might contain security measures that could prevent our application system from reading the file. Therefore, you should consider asking the institution to provide the file in a non-secured electronic format. Alternatively, you could scan or take a photo of the printed copy of the transcript. If your uploaded transcript cannot be read by our system, you may receive consideration and credit for the information we can access. Foreign Education: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For further information, visit the U.S. Department of Education website for Foreign Education Evaluation. To be acceptable, the foreign credential evaluation must include/describe at a minimum, the following information: (1) The type of education received by the applicant; (2) The level of education in relation to the U.S. education system, and state that its comparability recommendations follow the general guidelines of the International Evaluation Standards Council; (3) The content of the applicant's educational program earned abroad, and the standard obtained; (4) The status of the awarding foreign school's recognition and legitimacy in its home country's education system; and (5) Any other information of interest such as what the evaluation service did to obtain this information, the qualifications of the evaluator, and any indications as to other problems such as forgery. Note: Some positions require the completion of specific courses or a specified number of credit hours. Therefore, the foreign credential evaluation should provide information similar to that of an official transcript, to include a list of the courses taken, quarter and/or semester hours awarded, the cumulative grade point average (GPA), honors received, if any, date degree awarded. Applicants can request an evaluation from a member organization of one of the two national associations of credential evaluation services listed below: National Association of Credential Evaluation Services (NACES) Association of International Credentials Evaluators (AICE) Credential evaluations are not free, and applicants are responsible for the cost of the selected service. For more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation.