Deputy Center Director DutiesAs 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.
