Super Office Director, Office of Therapeutic Products (OTP)

About the role

This position is being filled under a streamlined 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 Table6, BandH.

Responsibilities

• 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.
• Led 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.

Requirements

You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration. This is a 21st Century Cures Act authority announcement. Traditional federal rules regarding rating, ranking, and veterans' preference do not apply.

Qualifications

• Scientific, Technical, and/or Professional Fields

• Qualified and Outstanding Candidates

• 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.

• 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.