Title 21: 21st Century Cures Act Positions
The 21st Century Cures Act was enacted on December 13, 2016 and Section 3072 of the Act grants the Commissioner of Food and Drugs the authority to appoint and set the annual rate of pay for outstanding and qualified candidates to scientific, technical, or professional positions that support the development, review, and regulation of medical products.
The positions listed below are being filled under an excepted hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The candidate selected for these positions will serve under a career or career-conditional appointment and be paid under the provisions of the authority. Additional information on 21st Century Cures Act can be found here
Title 21 Open Vacancies
Statistician (Statistical Analyst)
The Center for Drug Evaluation and Research (CDER), Office of Translational Sciences (OTS), Office of Biostatistics (OB), Division of Analytics and Informatics (DAI) is recruiting for a Statistician (Statistical Analyst) to conduct statistical methodology and reviews statistical methods for the analysis of data, primarily from clinical studies and serve as a technical resource for statistical methodology and its application.
Associate Director for Public Health Initiatives
The Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE) is recruiting for an Associate Director for Public Health Initiatives to assist the Super Office Director in executing the above responsibilities by serving as the Office’s lead scientific expert on Office activities related to complex, multidisciplinary drug safety matters with a broad public health impact.
Statistician
The Office of Regulatory Affairs (ORA) is recruiting for a Statistician to serve as a technical advisor to the Associate Commissioner for Regulatory Affairs (ACRA) and the Deputy ACRA (DACRA), analyzing FDA/ORA-wide cost initiative requirements and functions.
Physician (Endocrinologist)
The Center for Drug Evaluation and Research (CDER) , Office of New Drugs (OND), Office of Cardiology, Hematology, Endocrinology and Nephrology (OCHEN), Division of General Endocrinology (DGE) is recruiting for a Physician (Endocrinologist) who will be responsible for providing regulatory oversight for investigation studies during drug development and making decisions regarding marketing approval for new (innovative or non-generic) drugs.
Branch Chief, Office of Program and Regulatory Operations (OPRO)
The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of Program and Regulatory Operations (OPRO) is recruiting for a Branch Chief to oversee the operations, functions, and activities of the branch as carried out by highly trained professional and technical staff. The Branch Chief designs, develops, and implements internal processes to support drug quality assessment, in collaboration with the other OPQ and CDER offices.
Assistant Director (Division of Biology, Chemistry, and Materials Science)
The Center for Devices and Radiological Health (CDRH), Office of Science and Engineering Laboratories (OSEL), Division of Biology, Chemistry, and Materials Science (DBCMS) is recruiting for an Assistant Director to be responsible for providing leadership, administrative management, and exercising sound scientific and evidenced-based technical judgment in the areas of sterility and infection control.
Data Scientist (Resource Capacity Planning Staff)
The Center for Drug Evaluation and Research (CDER), Office of Strategic Programs (OSP), Office of Program and Strategic Analysis (OPSA), Resource Capacity Planning Staff (RCPS) is recruiting for a Data Scientist to serve as an analyst to provide consultative services to the Center and have a direct effect on decisions impacting major Center regulatory policies and programs.
Branch Chief (Supervisory Physician Hematology)
The Center for Biologics Evaluation and Research (CBER), Office of Tissues and Advanced Therapies (OTAT), Division Of Clinical Evaluation and Pharmacology/Toxicology (DCEPT) is recruiting for a Branch Chief (Supervisory Physician Hematology) to guide the clinical review program which include evaluating clinical data and protocols that involve biological products, especially cell and gene therapies, plasma derived products and devices, for the treatment of hematologic disorders.
Physician (Hematology)
The Center for Biologics Evaluation and Research (CBER), Office of Tissues and Advanced Therapies (OTAT), Division Of Clinical Evaluation and Pharmacology/Toxicology (DCEPT) is recruiting for a Physician (Hematology) to serve as a clinical reviewer, with a specialty in Hematology, who is a reviewer and advisor to the Division Director and other Center senior staff for the evaluation of the safety and effectiveness of novel biologic cell and gene therapies, plasma derived protein therapeutics, certain medical devices, and other OTAT regulated medical products.
Lead Physician (Hematology)
The Center for Biologics Evaluation and Research (CBER), Office of Tissues and Advanced Therapies (OTAT), Division Of Clinical Evaluation and Pharmacology/Toxicology (DCEPT) is recruiting for a Lead Physician (Hematology) to serve as a secondary reviewer and is one of the principal advisors to the Division Director and other Center senior staff for the evaluation of the safety and effectiveness of novel biologic cell and gene therapies, plasma derived protein therapeutics, certain medical devices, and other OTAT regulated medical products.
Associate Center Director for Drug Safety
The Center for Drug Evaluation and Research (CDER), Office of the Center Director (OCD), Immediate Office (IO) is recruiting for an Associate Center Director for Drug Safety to be responsible for the management of significant and/or controversial drug safety issues, as well as creation and oversight of CDER processes for management of all cross-Office and cross-Center safety issues. Provides overall direction to the Center in the formulation, development, implementation, and oversight of drug safety processes.
Lead Pharmacologist
The Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD), Office of Research and Standards (ORS) is recruiting for a Lead Pharmacologist to lead a team of professionals who, focusing on immediate release oral drug products, lead the product-specific guidance development process providing timely product specific guidance and pre-application scientific advice to generic drug developers.
Interdisciplinary Scientist
The Center for Drug Evaluation and Research (CDER), Office of Translational Sciences (OTS), Office of Study Integrity and Surveillance (OSIS) is recruiting for an Interdisciplinary Scientist to serve as a technical reviewer evaluating and conducting inspections of nonclinical, clinical, and bioanalytical studies supporting new and generic drug submissions to the FDA to help ensure the health and welfare of research participants, the reliability of study data, and compliance with United States laws and regulations, in support of protecting the public health.
Scientific Data Analyst
The Center for Biologics Evaluation and Research (CBER), Office of the Center Director (OD), Science Staff (SS) is recruiting for a Scientific Data Analyst to work as part of a team in managing multiple computer–based systems (i.e., Research Central and REES Environmental Monitoring System) that are used for monitoring and tracking regulatory science and research activities, such as research programs, publications, and related research program support budgets.
Office Director
The Center for Biologics Evaluation and Research (CBER), Office of Compliance and Biologics Quality (OCBQ) is hiring an Office Director to be responsible for ensuring the purity, potency and effectiveness of biologics products distributed in this country and that they are manufactured and distributed under the guidelines set forth by the Agency.
Operations Research Analyst, Lean Management Staff
The Center for Drug Evaluation and Research (CDER), Office of Strategic Programs (OSP), Office of Program and Strategic Analysis (OPSA), Lean Management Staff (LMS) is recruiting Operations Research Analyst to support the conceptualization, design, and conduct of complex studies into the operation and management of processes/programs within the Center.
Assistant Director, Infusion Devices
The Center for Devices and Radiological Health (CDRH), Office of Product Evaluation and Quality (OPEQ), Office of Health Technology 3 (OHT3), Division of Health Technology 3C (DHT3C) is recruiting for an Assistant Director, Infusion Devices to provide technical leadership and exercises scientific and engineering judgment in regulating various medical products, primarily drug infusion devices.
Deputy Division Director (Supervisory Data Scientist)
The Center for Devices and Radiological Health (CDRH), Office of Product Evaluation and Quality (OPEQ), Office of Clinical Evidence and Analysis (OCEA), Division of Clinical Evidence and Analysis II (DCEA2) is recruiting for a Deputy Division Director (Supervisory Data Scientist) to serve as the authoritative voice on analytical, statistical, and programmatic techniques to collect, organize, analyze, and interpret unique and highly specialized data sets related to the pre-market review, compliance assessment, and post-market surveillance of medical devices and products.
Artificial Intelligence Advisor
The Center for Devices and Radiological Health (CDRH), Office of Product Evaluation and Quality (OPEQ), Office of Clinical Evidence and Analysis (OCEA) is recruiting for a Artificial Intelligence Advisor to be charged with advancing the Office’s strategic vision for the development and implementation of AI and ML initiatives that support OCEA and OPEQ in the TPLC review of medical devices.
Interdisciplinary Scientist
The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) is recruiting for an Interdisciplinary Scientist to be responsible for reviewing and evaluating drug applications and communicates conclusions with a multidisciplinary review team.
Data Scientist (Analytics and Data Services Staff)
The Center for Drug Evaluation and Research (CDER), Office of Strategic Programs (OSP), Office of Program and Strategic Analysis (OPSA), Analytics and Data Services Staff (ADSS) is recruiting for a Data Scientist to be responsible for conducting and/or participating in the analysis of program policy and operations.