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
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.
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.
Deputy Office Director
The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of Quality Surveillance (OQS) is recruiting for a Deputy Office Director to provides leadership, program direction, and general supervision and oversight for the Office’s operations and all processes associated with pharmaceutical quality surveillance and intelligence-gathering that may affect and/or impact on agency-wide activities such as inspections, surveillance sampling, facility assessment, supply chain knowledge, surveillance policy development and mutual recognition policies.
Deputy Office Director
The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of Office of Testing and Research (OTR) is recruiting for a Deputy Office Director to serves as a primary advisor to the Office director. Collaborates with the Office Director, provides leadership, program direction, and general supervision and administrative oversight for OTR’s operations and all processes associated with the laboratory research on manufacturing, formulation, and characterization of drugs that supports the quality review, inspection, quality standard and policy development, education, and response activities.
OHT7 Deputy Division Director
The Center for Devices and Radiological Health (CDRH), Office of Product Evaluation and Quality (OPEQ), Office of Health Technology 7 (OHT7), Division of Program Operations and Management (DPOM) is recruiting for a Deputy Division Director to serve as a strategic, visionary, and team-oriented leader.
Deputy Office Director (Supervisory Consumer Safety Officer)
The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of Policy for Pharmaceutical Quality (OPPQ) is recruiting for a Deputy Office Director (Supervisory Consumer Safety Officer) to serve as a primary advisor to the Office Director and, in collaboration with the Office Director, provides leadership, program direction, and general supervision and oversight for OPPQ’s operations and all processes associated with the pharmaceutical quality.
Senior Scientific Advisor
The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of Quality Surveillance (OQS) is recruiting for a Senior Scientific Advisor to serve as an advisor to the Office Director and Deputy Office Director, as well as provides expert scientific input and direction on the quality surveillance practices or approaches and policies that affect the quality assessment, surveillance research and development, analytic tool development, and/or inspection activities related to quality surveillance.
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.
Division Director (Supervisory Interdisciplinary Scientist)
Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of Pharmaceutical Manufacturing Assessment (OPMA), Division of Biotechnology Manufacturing (DBM) is recruiting for a Division Director (Supervisory Interdisciplinary Scientist) to advise the Office Director and provides the scientific and technical expertise and managerial leadership pertaining to the scientific review and quality evaluation of the microbiological and manufacturing process data for Investigational New Drugs (INDs), Biologics License Applications (BLAs), Drug Master Files (DMFs), and supplemental BLAs assigned to the division.
Clinical Analyst
The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) is recruiting for a Clinical Analyst to evaluate submissions from applicants seeking permission to market new drugs for general use and make recommendations on the adequacy of the efficacy and/or safety data provided.
Staff Director
The Center for Drug Evaluation and Research (CDER), Office of the Center Director (OCD), Professional Affairs and Stakeholders Engagement Staff (PASE) is recruiting for a Staff Director who serves as the principle advisor to the Center Director and Deputy Center Director on all aspects of stakeholder engagement for patients and patient advocacy groups.
Interdisciplinary Scientist
The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of Biotechnology Products (OBP) is recruiting for an Interdisciplinary Scientist to participate in research programs in their area of expertise to contribute to the design and interpretation of experiments and results.
Deputy Director for Safety
The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) is recruiting for a Deputy Division Director for Safety within several of the OND clinical review divisions to be responsible for professional leadership and scientific direction to subordinate staff involved in the review and coordination of postmarket safety activities.
Data Scientists (Digital Health Specialists)
The Center for Devices and Radiological Health (CDRH), Office of Strategic Partnerships and Innovation (OST), Division of Digital Health (DDH) is recruiting for Data Scientists (Digital Health Specialists) to be responsible for planning, leading, and coordinating all data science related activities for the Digital Health Program.