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
Lead Pharmacologist
The Center for Drug Evaluation and Research (CDER), Office of Compliance (OC), Division of Enforcement and Postmarketing Safety (DEPS), Office of Scientific Investigations (OSI), Postmarket Safety Branch (PSB) is recruiting for a Lead Pharmacologist to serve as a source of informed opinion and information on medical and scientific matters related to CDER’s adherence to regulations and statues governing postmarket adverse drug experience reporting requirements.
Regulatory Counsel
The Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD), Office of Generic Drug Policy (OGDP), Division of Legal and Regulatory Support (DLRS) is recruiting for a Regulatory Counsel to develops policies and programs involving the most complex and highest priority matters affecting the regulation of generic drug products.
Deputy Division Director
The Center for Devices and Radiological Health (CDRH), Office of Science and Engineering Laboratories (OSEL), Division of Biomedical Physics (DBP) is recruiting a Deputy Division Director to be responsible for providing leadership, administrative management, and exercising sound scientific and evidenced-based technical judgement in the review of in-scope medical products throughout their total product lifecycle.
Supervisory Regulatory Counsel
The Center for Veterinary Medicine (CVM), Office of Surveillance and Compliance (OS&C) is recruiting for a Supervisory Regulatory Counsel to serve as an expert advisor to Office, Center, and Agency staff regarding the laws and regulations relating to pre-market surveillance and compliance activities of regulated animal products.
Regulatory Counsel
The Center for Veterinary Medicine (CVM), Office of the Director (OD) is recruiting for a Regulatory Counsel to conduct legal analyses of CVM and Agency records to determine whether documents can be released in litigation or in response to third-party subpoenas.
Science Policy Analyst (Band C)
The Center for Drug Evaluation & Research (CDER), Office of New Drugs (OND), Office of Rare Diseases, Pediatrics, Urologic & Reproductive Medicine (ORPURM), Division of Rare Diseases and Medical Genetics (DRDMG) is recruiting for a Science Policy Analyst to provide expertise to develop, maintain, and manage the administration the Rare Diseases Team’s multiple obligations to facilitate internal agency coordination and external engagement for our multiple external stakeholders (e.g., industry, foundations, and patient advocacy groups).
Science Policy Analyst (Band D)
The Center for Drug Evaluation & Research (CDER), Office of New Drugs (OND), Office of Rare Diseases, Pediatrics, Urologic & Reproductive Medicine (ORPURM), Division of Rare Diseases and Medical Genetics (DRDMG) is recruiting for a Science Policy Analyst to provide support to the Supervisory Associate Director on matters that have a direct effect on the review and evaluation of rare disease drug development actions, policies, and programs.
Science Policy Analyst (Band A, B, C)
The Center for Drug Evaluation and Research (CDER), Office of the Center Director (OCD), Patient Focused Drug Development (PFDD) is recruiting for a Science Policy Analyst to Provides assistance related to the planning, development, administration, execution, and coordination of programs, initiatives, and policies in Patient Focused Drug Development.
Science Policy Analyst (Band D)
The Center for Drug Evaluation and Research (CDER), Office of the Center Director (OCD), Patient Focused Drug Development (PFDD) is recruiting for a Science Policy Analyst to provide advice on matters that have a direct effect on patient focused actions, policies, and programs.
Safety Regulatory Health Project Manager (Multiple Vacancies)
The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) is recruiting for a Safety Regulatory Health Project Manager to serve as a manager for all postmarketing safety activities (such as those related to FDA’s Safety First and Safe Use Initiatives), including postmarketing studies and clinical trials, within one of the OND clinical review divisions listed below.
Lead Physician
The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND), Office of Non Prescription Drugs (ONPD), Division of Non Prescription Drugs II (DNPDII) is hiring for a Lead Physician to be responsible for assisting the supervisor with administrative direction and oversight in their assigned clinical division.
Branch Chief (Supervisory Physician)
The Center for Drug Evaluation and Research (CDER), Office of Compliance (OC), Office of Scientific Investigations (OSI) is recruiting for a Branch Chief (Supervisory Physician) to serve as a technical and scientific authority in the area of Good Clinical Practice (GCP), including data integrity and clinical trial conduct, evaluating the reliability of clinical data relating to the safety and effectiveness of a broad range of drugs pending approval before CDER.
Supervisory Associate Director for Scientific Coordination (Supervisory Interdisciplinary Scientist)
The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of Biotechnology Products (OBP) is recruiting for Supervisory Associate Director for Scientific Coordination (Supervisory Interdisciplinary Scientist) to oversee and coordinate the overall regulation of human pharmaceutical quality within CDER, including submission review, manufacturing facility assessment, and surveillance of the quality of marketed pharmaceutical products.
Chief Physician (Office of Clinical Evidence and Analysis (OCEA))
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 Chief Physician to serve as program manager and primary contact medical device clinical issues.
Pharmaceutical Scientist
The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ) is hiring for a Pharmaceutical Scientist to be responsible for reviewing and evaluating comprehensive information and data on chemistry, formulation, manufacturing (including process monitoring and controls), biopharmaceutics (including drug release), as well as technical aspects of labeling and environmental impact submitted in Biologic License Agreements (BLAs), New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and supplemental BLAs, NDAs, as appropriate.
Supervisory Associate Director
The Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD), Office of Safety and Clinical Evaluation (OSCE), Division of Clinical Review (DCR) is recruiting for a Supervisory Associate Director to assists DCR’s management team to oversee the scientific review activities of each review team and serves as an authoritative source and leading expert in guiding DCR’s multidisciplinary scientific/clinical teams.
Division Director (Supervisory Pharmacologist)
The Center for Drug Evaluation and Research (CDER), Office of New Drug Products (ONDP), Division of Biopharmaceutics (DB) is recruiting for a Division Director (Supervisory Pharmacologist) to oversee, direct, and plan activities related to the evaluation and assessment of relevant biopharmaceutics information for INDs, NDAs, ANDAs, supplemental NDAs (sNDAs), and supplemental ANDAs (sANDAs), and makes risk-informed recommendations on the approvability of such products to stakeholders.
Director, Office of Vaccines Review and Research (OVRR)
The Center for Biologics Evaluation and Research (CBER), Office of Vaccines Review and Research (OVRR) are is recruiting for a Director to review and evaluate the safety and efficacy of investigational new drug applications (INDs) and IND amendments for vaccines and related biological products, provide guidance and recommendations to IND sponsors with regard to the chemistry, manufacturing and control information, preclinical safety assessments and first-in-man clinical trials for these products.
Senior Science Policy Advisor
The Center for Drug Evaluation and Research (CDER), Office of the Center Director (OCD), Controlled Substance Program (CSP) is recruiting for a Senior Science Policy Advisor to serve as the Center lead on policy efforts surrounding the research and regulation of cannabis in addition to working on issues related to other controlled substances with potential for abuse.
Deputy Director
The Office of the Commissioner, Office of Policy, Legislation and International Affairs, Office of Global Policy and Strategy is recruiting for a Deputy Director to serve as principal advisor to the Associate Commissioner for Global Policy and Strategy.
Assistant Director
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 advance the mission of OSEL and directly impact the health outcomes and the quality of life of the American people.
Interdisciplinary Scientist
The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) is recruiting for an Interdisciplinary Scientist to review and evaluate drug applications and communicates conclusions with a multidisciplinary review team.
Quality Assurance Specialist
The Office of Pharmaceutical Quality (OPQ), Office of Testing and Research (OTR) is recruiting for a Quality Assurance Specialist to implement the Quality Management Plan (QMP) or other established guidelines for the CDER Quality Management System (QMS) for the chemistry, manufacturing, and controls (CMC) review processes.
Director of Technology and Delivery
The Office of the Commissioner, Office of Digital Transformation, Office of Information Management & Technology is recruiting for a Director of Technology and Delivery to serve as an advisor to the Chief Technology Officer and senior management officials across FDA.
Division Director (Physician)
The Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD), Office of Safety and Clinical Evaluation (OSCE), Division of Clinical Review (DCR) is recruiting for a Division Director (Physician) to serve as an advisor to the Director and Deputy Director of OSCE, and is responsible for planning, coordinating, and evaluating the programs and activities of the division.
Assistant Director (Supervisory Data Scientist)
The Center for Devices and Radiological Health (CDRH), Office of Product Evaluation and Quality (OPEQ), Office of Regulatory Program (ORP) is recruiting for an Assistant Director (Supervisory Data Scientist) to be responsible for planning, leading, and coordinating all data analytics activities, to include developing performance dashboards, decision memoranda and reports, and review tools to ensure the reliability of reported data and to assist in evidence-based decision making throughout the total product lifecycle of medical devices regulated by the Center.
Consumer Safety Officer (Regulatory Project Manager)
The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of Program and Regulatory Operations (OPRO) is recruiting for a Consumer Safety Officer (Regulatory Project Manager) to be responsible for triaging and assigning application submissions to the applicable program assessment area(s).
Deputy Division Director
The Center for Devices and Radiological Health (CDRH), Office of Science and Engineering Laboratories (OSEL), Division of Imaging, Diagnostics, and Software Reliability (DIDSR) is recruiting for a Deputy Division Director to be responsible for providing leadership, administrative management, and exercising sound scientific and evidenced-based technical judgement in the review of in-scope medical products throughout their total product lifecycle.
Biopharmaceutics Reviewer (Interdisciplinary Scientist)
The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of New Drug Products (ONDP), Division of Biopharmaceutics (DB) is recruiting for a Biopharmaceutics Reviewer (Interdisciplinary Scientist) to be responsible for reviews of in silico, in vitro, and human PK data submitted to INDs, NDAs, ANDAs, sNDAs, and sANDAs to evaluate the mechanism of action (MOA) as proof-of-activity for use of medicinal products in patients, the safety of medicinal products for use in patients and health subjects, and the quality profile of medicinal products in patients in order to recommend approval of applications.
Associate Director (Epidemiologist)
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 an Associate Director (Epidemiologist) who is dedicated to improving the health outcomes of patients through innovation, evidence-based decision making, clinical/patient outcome data, and the advancement of therapeutic and diagnostic medical devices.
Division Director, Division of Learning and Organizational Development (DLOD)
The Center for Drug Evaluation and Research (CDER), Office of Executive Programs (OEP), Division of Learning and Organizational Development (DLOD) is recruiting for a Division Director to be responsible for leading and implementing the Center’s training and employee development strategy.
Interdisciplinary Scientist
The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) is recruiting for a Interdisciplinary Scientist to review and evaluate drug applications and communicate conclusions with a multidisciplinary review team.