Supervisory Associate Director for Real World Evidence Analytics (RWE) (Supervisory Physician)

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 or Agency) 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. 

The mission of 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 over-the-counter and prescription drugs, including biological therapeutics and generic drugs. 
 
The Office of Medical Policy (OMP) is responsible for directing medical policy programs and strategic initiatives, including evaluation of real-world evidence with a focus on supporting approval of new indications both in the pre- and post-market setting as mandated by 21st Century Cures Act. OMP provides leadership and scientific advice in novel clinical trial designs, in particular the use of new technologies, and direction in policy issues related to human subject protection and good clinical practices. OMP accomplishes its mission through the development of regulation, guidance documents, and procedures related to medical policy issues. 

The Immediate Office (IO) within the Office of Medical Policy in the Center for Drug Evaluation and Research (CDER) promotes and protects public health by providing scientific and regulatory leadership in the development of medical policy pertaining to drug development, drug bioresearch monitoring, human subject protection, post market surveillance processes, and the science and efficiency of clinical trials. It supports innovative approaches to clinical trials that include the use of technology, real world evidence and decentralized clinical. 

Duties/Responsibilities 

As the Supervisory Associate Director for Real World Evidence Analytics (RWE) (Supervisory Physician), the incumbent provides strategic vision for the agency’s effort to evaluate and promote the use of RWE to advance drug development and to further evaluate the safety and effectiveness of marketed therapies. Resource management at this level involves major decisions and actions with direct and substantial effect on the organizations and programs managed.  

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. 

Communicates with international regulators through leadership of the FDA-EMA RWE Cluster and related international regulatory liaison mechanisms. 

Provides strategic and clinical guidance for agency review of RWE submissions by managing input from senior CDER, OCE, CBER, and CDRH staff as Chair of the Medical Policy and Program Review Council RWE Subcommittee and any future bodies that would coordinate, guide, coordinate, and advice CDER on RWE submissions, policies, and projects. 

Provides matrixed leadership for guidance development workgroups composed of staff from multiple CDER Super-Offices as well as CBER and CDRH to identify scientific and policy challenges and manage contracts and grants totaling millions of dollars. 

Leverages prior FDA review and technology transfer experience as well as information from a trans-FDA RWE Subcommittee to identify key hurdles for the adoption of RWE. Reviews and initiate demonstration projects to close these gaps in real world data utilization. 

Manages staff and serves as a member of the FDA Sentinel Executive Committee which provides governance among OC, CDER, CBER, and CDRH with respect to core Sentinel activities as well as specialized sub-systems within Sentinel such as FDA-Catalyst. 

Engages in external and internal stakeholder outreach and communication regarding best practices in data quality, study design, and other foundations of real-world evidence generation and clinical trial optimization by planning and participating in FDA-sponsored public meetings convening thought leaders across sectors. 

Supports the Super Office Director with subject matter expertise on various clinical, policy, technical, regulatory, and management matters related to the Office’s guidance and scientific policy activities. The incumbent is able to provide authoritative responses for requests from the US Congress, trade associations, foreign governments, other parts of the agency and the public. 

Uses high degree of originality in devising new and adapting existing methods and techniques to resolve problems and fulfill objectives. 

Creates and oversees the formulation of long-range plans with respect to the Agency’s evaluation of real-world evidence, which may require the application of clinical, epidemiological, and regulatory knowledge. 

Provides technical assistance to other professionals in the organization on the use of real-world evidence to evaluate effectiveness, and/or safety use cases. 

Keeps the Super Office Director, informed of programs, resources, and related considerations that would impact the Agency’s evaluation of real-world evidence. 

Supervisory Responsibilities: Manages multiple projects and provides leadership to the RWE Analytics Team. Supervises and evaluates scientists who serve as experts in their field. Provides technical and administrative direction and supervision 25 percent or more of the time to subordinate staff performing the work and functions of the organizational unit. Obtains resources and manages over $22 million in agency resources to ensure that the work performed is of proper scientific quality and meets the objectives of the agency. 

How to Apply 

Submit resume or curriculum vitae with cover letter by October 16, 2024, to: CDER-OMP-IO-Jobs at CDER-OMP-IO-Jobs@fda.hhs.gov. Candidate resumes may be shared with hiring official within the Center for Drug Evaluation and Research with a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not share”.  
 
Please reference Job Reference ID:  T-40-42 Supervisory Associate Director in the email subject line. 

Announcement Contact 

For questions regarding this Cures position, please contact CDER-OMP-IO-Jobs@fda.hhs.gov. 

The Department of Health and Human Services is an equal opportunity employer with a smoke free environment. 

FDA is an equal opportunity employer.