Super Office Director, Office of Therapeutic Products (OTP)

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