Super Office Director, Office of Therapeutic Products

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.

Qualifications

In order to qualify for the Super Office Director, Office of Therapeutic Products position which falls under the 0602 occupational Series, you must meet the following requirements by 11:59 pm EST on 10/13/2026:The candidate must meet the following qualifications for this Title 21 position: Scientific, Technical, and/or Professional Fields Qualified and Outstanding Candidates a. Qualified applies to all candidates for Cures appointments. The FDA OTS will use the technical qualifications defined below 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. Technical Requirements: (Do not submit narrative responses, these qualifications must be included in your 2-page resume) Experience in scientific and technical leadership, direction, and supervision to multidisciplinary scientific, engineering and medical science staff. Proven ability to provide strategic scientific and technical counsel to senior leadership on complex, novel, controversial, and precedent-setting regulatory and policy issues, and to evaluate and apply regulatory requirements in support of public health decision-making. Desired Qualifications: Demonstrated expertise in cellular and gene therapies, therapeutic vaccines, plasma-derived and coagulation products, and associated medical devices, including comprehensive knowledge of FDA regulatory authorities, policies, and guidance. Collaborates with other scientific, technical, and regulatory staff to develop and implement policy initiatives related to cellular, tissue gene therapy (including viral and non-viral vectors), therapeutic vaccines, and plasma-derived and coagulation products as well as associated medical devices. NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications. Supervisory Responsibilities The incumbent is delegated full authority to achieve group goals and objectives through the effective management of available resources. Performance and accomplishments are assessed primarily through work performance indicators, staff discussion, planning sessions, review of individual project outputs, and annual program review. Leads in a proactive, customer-responsive manner consistent with Agency vision and values, effectively communicating program issues to external audiences. Ensures financial and managerial accountability by acting with prudence when executing fiduciary responsibilities. Demonstrates high integrity and adheres to the highest ethical standards of public service. Uses effective business practices including balanced measures of results, values, and invests in each employee; emphasizes empowerment and two-way communication. Takes a leadership role in advocating for and advancing the priorities of the Agency. Serves as a role model for leadership by encouraging teamwork and a collaborative approach. Timely notifies Agency officials of all significant actions and developments, including but not limited to those related to regulatory matters, legislative matters, budget matters, reports, initiatives, and events and ensures subordinate managers do the same. Provides reasonable accommodations needed to best utilize qualified people with disabilities. Ethics Clearance Requirements This position requires financial disclosure reporting and will be subject to FDA's prohibited financial interest regulation. If you are hired, you may be required to divest of certain financial interests. You are advised to seek additional information on this requirement from the hiring official before accepting any job offers. For more information, please visit the FDA Ethics web page: https://www.fda.gov/about-fda/jobs-and-training-fda/ethics. All requirements must be met by the closing date of this announcement (10/13/2026); only education and experience gained by this date will be considered. You must continue to meet all requirements throughout the entire hiring process.

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