This position is being filled under a stream-lined hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority.
Additional information on 21st Century Cures Act can be found here:
21st Century Cures Act Information
Introduction
The Food and Drug Administration (FDA) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices safe, and effective.
Center for Drug Evaluation and Research (CDER) is to perform an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. CDER regulates and prescription drugs, including biological
therapeutics and generic drugs.
The Office of the Center Director (OCD) Immediate Office (IO) provides leadership and overall direction to all CDER activities to ensure that the mission of the Center is accomplished. CDER makes sure that safe and effective drugs are available to improve the health of consumers. CDER ensures that prescription and over-the-counter drugs, both brand name and generic, work correctly and that the health benefits outweigh known risks.
Duties/Responsibilities
As the Associate Director for Real World Evidence (RWE) Analytics, the incumbent leads CDER’s RWE program and provides strategic vision and direction for the agency's effort to evaluate and promote the use of real world evidence to advance efficient drug development, including for chronic diseases that impact many Americans and for which RWE can promote efficient evaluation of the safety and effectiveness. Resource management at this level involves major decisions and actions which have a direct and substantial effect on the organizations and programs managed but also on the technology development, clinical and epidemiologic strategies, and regulatory convergence in the broader drug development community and internationally.
In this capacity, the incumbent is responsible for the following:
- Serves as the principal external spokesperson for the Center for RWE, as well as a senior spokesperson for related efforts to increase the efficiency and utility of clinical trials through use of real world data, artificial intelligence, digital technology and advanced analytics.
- Communicating with international regulators through leadership of the FDA, European Medicines Agency (EMA), and RWE Cluster and related international regulatory liaison mechanisms.
- As the Chair RWE Senior Advisory Committee , the incumbent provides strategic and clinical guidance for agency review of RWE submissions by managing input from senior Center for Drug Evaluation and Research (CDER), Oncology Center of Excellence (OCE), Center for Biologics Evaluation and Research (CBER), and Center for Devices and Radiological Health (CDRH) staff, and any future bodies that would coordinate, guide, and advise on RWE submissions, policies, and projects. Provides technical assistance to other professionals in the organization on the use of real-world evidence to evaluate the effectiveness and safety of medical products.
- Provides matrixed leadership for guidance development and workgroups composed of staff from multiple CDER Offices, as well as CBER and CDRH to identify and address scientific and policy challenges.
- Provide strategic direction for investment in regulatory science related to RWE and oversee contracts and grants totaling millions of dollars.
- Leverages prior FDA review and technology transfer experiences as well as input from other CDER offices to identify key gaps preventing wider adoption of RWE. Reviews existing resources initiates internal and external partnerships and directs staff who evaluate, and initiate demonstration projects designed to close these gaps in the areas of real-world data utilization, real world evidence generation, and submission standards for FDA.
- Keeps the Center Director, and Principal Deputy Commissioner and other officials fully informed of programs, resources, and related considerations that would impact the Agency's evaluation of real-world evidence and the implementation of relevant portions of the Agency's Technology Modernization Action Plan.
- The Associate Director for RWE Analytics will work closely with CDER experts, as well as relevant staff across FDA (e.g., in other centers or in the Office of the Commissioner) to optimize opportunities for external engagement and communication, and internal communication and integration. Because of the important ongoing programs throughout CDER, this individual is expected to integrate and align with leadership in these programs to assure seamless internal and external efforts. They will coordinate with ongoing scientific, regulatory policy and communication efforts, assuring close partnership with the relevant programs within CDER.
Supervisory Responsibilities: N/A
How to Apply
Submit resume or curriculum vitae with cover letter by January 21, 2024, to: CDER-OCD-OEP-Hires@fda.hhs.gov. Candidate resumes may be shared with hiring official within the Center for Drug Evaluation and Research (CDER) with a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not share”.
Announcement Contact
For questions, please contact CDER-OCD-OEP-Hires@fda.hhs.gov.
Please reference Job ID: Associate Director for RWE Analytics in the email subject line.
The U.S. Department of Health and Human Services is an equal opportunity employer with a smoke free environment.
FDA is an equal opportunity employer.
