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.

The mission of the 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 New Drugs (OND) is a super office within CDER responsible for the assessment of new drugs and therapeutic biologics. OND provides clinical, nonclinical, and regulatory expertise on the full range of drugs and therapeutic biologics that can be made available to the American people.

The mission of the Immediate Office (IO) is to facilitate the ongoing availability of new drugs that are safe and effective for their intended use and meet established quality standards.

The Safety, Policy, Research, and Initiatives Team (SPiRIT) supports all areas of drug product safety within OND and CDER, through the development of methods, policies, and procedures that ensure a consistent and unified approach to drug safety. The SPiRIT Team has three areas consisting of Policy, Research, and Initiatives. SPiRIT works collaboratively with the OND Clinical Offices, Office of Surveillance and Epidemiology, and other Center and Agency offices to support continuing surveillance and medical evaluation of drug safety, including clinical reports submitted by IND sponsors, New Drug Applications (NDA) applicants, Biological Licensing Applications (BLA)s and from other sources.

Duties/Responsibilities

As a Clinical Analyst within SPiRIT, the incumbent participates in the development and implementation of programs and initiatives to support policies, procedures, research, and operations related to the postmarket drug safety program.

• Provides expert advice and consultation to senior leadership and other key members of OND and CDER staff. Works closely with team lead and other stakeholders to advise, mentor, and assist in defining, formulating, and ensuring successful implementation and effectiveness of new policies, processes, and various initiatives that meet the needs of OND’s safety functions. Serves as a regulatory expert for safety-related laws and regulations; applies knowledge of FDA and CDER policies and procedures to identify and resolve complex issues and inconsistencies and make recommendations on strategic safety initiatives, ensuring cohesive implementation of changes.
• Facilitates and coordinates consistent regulatory approaches to the oversight of postmarket drug safety review to support drug product safety within OND. Serves as a resource to CDER staff engaged in review of postmarket safety issues, providing direct guidance on the interpretation and implementation of the FDA safety authorities. Provides expertise during the development and revision of post market safety related MAPPS, guidance’s, and other regulatory documents to ensure consistency in oversight. Provides subject matter expertise in coordination and consultation with OND Policy, Office of Surveillance and Epidemiology (OSE), Office of Regulatory Policy (ORP), Office of Chief Counsel (OCC) and other offices, as appropriate, on post market safety related inquiries to formulate cohesive responses as well as provide guidance for precedent setting safety issues.
• Provides scientific and technical subject matter expertise and input in developing, implementing, and analyzing the effects of drug safety programs and the establishment of safety research projects. Researches and analyzes safety issues, reviews projects to ensure appropriate application of various safety guidelines and authorities implemented by FDA, resolves inconsistencies in the application of drug safety policies and regulations requiring innovative approaches, and makes recommendations on strategic plans for drug safety. Analyzes and provides appropriate recommendations pertaining to the conduct of studies from pilot programs and other post marketing safety initiatives on internal procedures for the purpose of finding ways to improve efficiency and ensure consistency in OND’s approaches to the evaluation and management of drug safety issues. Coordinates, conducts, leads, and facilitates the development of new research projects, time frames, milestones, and agreed upon endpoints.
• Monitors and complies reports on the status for various assigned activities within the drug safety research program through interaction with program participants. Develops and compiles necessary background data pertinent to OND and CDER programs, through a wide variety of qualitative and quantitative methods to prepare special reports related to drug safety. Provides expert clinical analysis on current and emerging complex safety issues and programs and provides input of viable solutions on these issues to the Supervisory Associate Director and/or Team Lead.
• Organizes and/or provides training/presentations related to drug safety in collaboration with OND Learning and Talent Development Staff and other Center programs to develop and provide oversight of safety related training, curriculum, and resources to advance the understanding of postmarket safety science and pharmacovigilance if applicable. Responsible for establishing and maintaining effective communications and collaboration with safety staff and other offices and centers responsible for implementation of various drug safety programs, and initiatives.
• Provides subject matter expertise and represents the CDER/OND/SPiRIT on committees, task forces, and other forums related to the planning, development, administration, and coordination of drug safety initiatives. Serves as a liaison to external entities such as industry, professional organizations, academia, other regulatory agencies, and the public in the gathering of information to guide plans for the development of the post marketing safety initiatives and policies.

Supervisory Responsibilities: N/A

How to Apply

Submit resume with cover letter and unofficial transcripts by June 14, 2024, to Keya Whitaker at ONDIORecruitment@fda.hhs.gov. Candidate resumes may be shared with hiring officials within the CDER with a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not share”

Please reference Job Reference ID: IO-24-049 in the email subject line.

Announcement Contact

For questions regarding this Cures position, please contact Danielle Wright at Danielle.Wright@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.