Super Office Director, Office of Therapeutic Products (OTP)

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 6, Band H. .

Duties

• Oversees planning, development, and direction of patient-focused, risk-based strategies to secure safety, efficacy, and quality of cellular, tissue, gene therapy, therapeutic vaccines, plasma-derived/coagulation products, and related devices.
• Advises the Center Director and other officials on the Food and Drug Administration’s (FDA) regulatory and enforcement responsibilities and possible risks.
• Implements programs and projects to identify, assess, and prioritize the public health significance and patient risk regarding safety concerns.
• Leads and oversees development of products enforcement and compliance policy and standards; contributes to planning and development of patient-focused, risk-based compliance and enforcement strategies to secure safety, efficacy, and quality.
• Executes high-level decisions, monitors performance, and directs strategies and operations of component Offices to ensure compliance and enforcement decisions and policies are patient-focused and risk-based.
• Designs and develops internal procedures and processes to support work quality and provides oversight of implementation, monitoring, and continual improvement of the quality system.
• Develops, coordinates, and implements post-market risk assessment policies, guidance, and interpretations and, when appropriate, initiates the development or enhancement of regulations.
• Ensures that office functions and program activities are aligned to the overall strategy and priorities of CBER and FDA.
• Facilitates Super Office staff coordination between multiple, smaller program offices.
• Oversees center or office research activities, including determining if research is appropriate.
• Provides oversight for activities related to international guideline development within the Super Office to improve efficiency with the goal of reducing decision time.

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 Requirements: A degree from an accredited program or *institution in Doctor of Medicine, Doctor of Osteopathic Medicine, or equivalent. *Degree from Foreign Medical School: A Doctor of Medicine or equivalent degree from a foreign medical school must provide education and medical knowledge equivalent to accredited schools in the United States. Evidence of equivalency to accredited schools in the United States is demonstrated by permanent certification by the Educational Commission for Foreign Medical Graduates. AND Graduate Training: In addition to a degree, a candidate must have had at least one year of supervised experience providing direct service in a clinical setting. For purposes of this standard, graduate training programs include only those internship, residency, and fellowship programs that are approved by accrediting bodies recognized within the US or Canada. TRANSCRIPTS: Positions which are scientific or technical in nature often have very specific educational requirements. You must submit an official transcript, unofficial transcript, or a list 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.