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
Business Informatics Specialist
The Center for Drug Evaluation and Research (CDER), Office of Strategic Programs (OSP), Office of Business Informatics (OBI), Immediate Office (IO), Division of Drug Quality and Compliance Services and Solutions (DDQCSS), Division of Business Management Services and Solutions (DBMSS) is recruiting for a Business Informatics Specialist to performs a variety of complex activities to include business analysis, project management, communication to understand and document business needs, develop strategies to meet those needs, and execute informatics projects.
NOTE: This is a Temporary appointment not-to-exceed September 30, 2023. There may be consideration for a Permanent appointment opportunity.
Computer Scientist
The Center for Drug Evaluation and Research (CDER), Office of Strategic Programs (OSP), Office of Business Informatics (OBI), Immediate Office (IO), Division of Drug Quality and Compliance Services and Solutions (DDQCSS), Division of Business Management Services and Solutions (DBMSS) is recruiting for a Computer Scientist to meet mission-critical informatics initiatives in support of CDER’s regulatory operations by assisting in the development of software systems that form the basis of the modern computing environment for scientific review of human drugs and therapeutic biologics.
NOTE: This is a Temporary appointment not-to-exceed September 30, 2023. There may be consideration for a Permanent appointment opportunity.
Senior Advisor for Translational Science
The Center for Biologics Evaluation and Research (CBER), Immediate Office of the Center Director (OCD) is recruiting for a Senior Advisor for Translational Science to provides strategic leadership in the development and execution of CBER’s goals and priorities for collaborations and outreach in the area of translational science.
Director, Epidemiology I
The Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE) is recruiting for a Director, Epidemiology I to be responsible for collaborating with all CDER offices and Agency representatives in the other Centers and FDA Commissioner’s Office to optimize risk assessment to promote safe and effective use of drugs and therapeutic biologics, using best practices in epidemiology to enhance regulatory decision making.
Social Scientist, PEIS
The Center for Drug Evaluation and Research (CDER), Office of Strategic Programs (OSP), Office of Program and Strategic Analysis (OPSA), Program Evaluation and Implementation Staff (PEIS) is recruiting for a Social Scientist to draw on principles of evaluation, sociology, psychology, and economics.
Associate Director for Scientific Affairs
The Center for Drug Evaluation and Research (CDER), Office of Compliance (OC), Office of Scientific Investigations (OSI) is recruiting for an Associate Director for Scientific Affairs to develop and execute overall strategy for international collaboration and outreach for the Division and serves as a senior expert within the Division on working groups to develop new or revised regulations and guidance related to programs within the Division.
Supervisory Ethics Liaison
The Center for Drug Evaluation and Research (CDER), Office of Management (OM) is recruiting for a Supervisory Ethics Liaison to manage the strategic planning and development of the CDER Ethics Program, including Center-specific tools and systems designed to streamline the Center's Ethics processes delegated by the Office of Ethics and Integrity (OEI).
Consumer Safety Officer (Investigator)
The Office of Regulatory Affairs (ORA), Office of Medical Products and Tobacco Operations (OMPTO), Office of Bioresearch Monitoring Operations (OBIMO) is recruiting for a Consumer Safety Officer (Investigator) to cover large, medium, and small firms, complex investigations and inspections of various industry establishments covered by the program such as: clinical investigators, sponsors, contract research organizations, institutional review boards, nonclinical laboratories, post marketing adverse drug experience reporting, and risk evaluation and mitigation strategies.
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 for an Operations Research Analyst to support the conceptualization, design, and conduct of complex studies into the operation and management of processes/programs within the Center.
Statistician
The Center for Biologics Evaluation and Research (CBER), Office of Biostatistics and Pharmacovigilance (OBPV), Division of Biostatistics (DB) is recruiting for a Statistician to use scientific knowledge of the theories, principles and concepts of statistics to conduct meaningful analyses and interpretation of clinical safety data.
Physician (Psychiatrist)
The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND), Office of Neuroscience (ON), Division of Psychiatry (DP) is recruiting for a Physician (Psychiatrist) to be responsible for providing regulatory oversight for investigational studies during drug development and making decisions regarding marketing approval for new (innovative or non-generic) drugs
Regulatory Counsel
The Center for Drug Evaluation and Research (CDER), Office of Regulatory Policy (ORP) is recruiting for a Regulatory Counsel to be responsible for writing regulations, preparing responses to citizen petitions, petitions for stay of action, and/or petitions for reconsideration; drafting and commenting on legislation; and providing advice on the interpretations of the laws, regulations and policies applicable to the FDA.
Pharmacokineticist
The Center for Drug Evaluation and Research (CDER), Office of Translational Sciences (OTS), Office of Clinical Pharmacology (OCP) is recruiting for a Pharmacokineticist to provide special scientific expertise in biopharmaceutics and pharmacokinetics; consults with members of the division on the use of computers in statistical pharmacokinetic analysis
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.
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.
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.
Division Director
The Center for Biologics Evaluation and Research (CBER), Office of Tissues and Advanced Therapies (OTAT), Division of Cellular and Gene Therapies (DCGT) is recruiting for a Division Director to review, evaluate and recommend appropriate action on investigational new drug applications (INDs), Biologics License Applications (BLAs), new drug applications (NDAs), and 510 (k) and premarket applications (PMAs).