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
Scientific Lead for Rare Disease Endpoint Advancement Commitment
The Center for Drug Evaluation and Research (CDER), Office of New Drugs’s (OND) is recruiting a Scientific Lead for Rare Disease Endpoint Advancement Commitment. As the Scientific Lead for Rare Disease Endpoint Advancement Commitment, the incumbent will be responsible for assisting the supervisor with administrative direction and scientific oversight in their assigned clinical division.
Physician (Hematology)
CBER is recruiting a Physician who will 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)
CBER is recruiting a Lead Physician, with a specialty in Hematology, who serves 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. The physician evaluates clinical trial designs for a variety of hematologic indications. This position can operate in either the Malignant Hematology Branch or the Benign Hematology Branch, as appropriate. *Multiple selections will be made from this announcement (Malignant Hematology Branch and Nonmalignant Hematology Branch).
Branch Chief
The Center for Biologics Evaluation and Research (CBER) is recruiting a Brand Chief to serve the Division of Acquisitions and Budget Resources (DABR) Budget Planning and Execution Branch (BPEB) and manage the daily operations of the Branch. As Branch Chief, the incumbent provides comprehensive management and operational activities related to all funding types within CBER. The Branch Chief reports to the DABR Division Director.
Physician (Psychiatrist)
The Center for Drug Evaluation and Research (CDER), Office of New Drugs’s (OND) is recruiting a Physician (Psychiatrist). As a Physician (Psychiatrist), the incumbent will 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.
Physician
The Center for Drug Evaluation and Research (CDER), Office of Medical Policy (OMP) is recruiting for a Physician. As a Physician, the incumbent serves as a scientific and regulatory subject-matter expert for real-world evidence (RWE) analytics in the Immediate Office of the Office of Medical Policy (OMP). The incumbent is responsible for gathering, processing, and evaluating information related to RWE analytics.
Dental Officer
The Center for Drug Evaluation and Research (CDER), Office of New Drugs’s (OND) is recruiting a Dental Officer who will 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, including decisions related to changes to already marketed products; monitoring the post market safety and effectiveness of medical drug products marked and used nationwide; advising on policy guidance, documenting review and interpretations of legislation affecting new drugs; establishing policies regarding the analysis and interpretation of surveillance or regulation of new drugs, generic or over-the-counter drugs; providing guidance on safe and effective drug issues; determining the safety or efficacy of consumer drugs in clinical settings; and serve as the technical expert on medical drug product issues to the FDA and external organizations within the private and public sectors.
Pharmaceutical Scientist
The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ) is recruiting a Pharmaceutical Scientist, who will 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.
Data Scientist
The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ) is recruiting for a Data Scientist. As a Data Scientist, the incumbent serves as a specialist in the application of data science, operations research, computer science, mathematics, and statistics, to design data modeling processes, uncover hidden patterns in the data, and create algorithms and predictive models to extract insights that improve the assessment of the state of pharmaceutical quality.
Deputy for Technology and Bioresearch Quality and Support Operations
FDA’s Office of Regulatory Affairs (ORA) is recruiting a Deputy for Technology and Bioresearch Quality and Support Operations. The Deputy for Technology and Bioresearch Quality and Support Operations (Deputy) shares fully with the ACMPTO in the facilitation of office staff coordination between multiple program offices. The incumbent advises the ACMPTO and other senior managers and staff on program issues and problems.
Science Disclosure Analyst
The Center for Biologics Evaluation and Research (CBER) is recruiting a Science Disclosure Analyst within the Access Litigation and Freedom of Information Act (FOIA) Branch (ALFOIB) in the Division of Disclosure and Oversight Management (DDOM) under the Office of Communication Outreach and Development (OCOD). This position reports to the Chief of ALFOIB. The incumbent uses scientific knowledge to implement and ensure compliance of statutory requirements for the public release of information about technical scientific information specific to applications for an array of biological products, both investigational and licensed, including allergenic, blood and blood components, medical devices and tests, gene therapy, human tissues and cellular products, vaccines, and xenotransplantation products.
Supervisory Regulatory Health Project Manager
The Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE) is recruiting for a Supervisory Regulatory Health Project Manager. As a Supervisory Regulatory Health Project Manager within OSE’s Project Management Staff the incumbent supervises a staff of multidisciplinary individuals who participate in the review of pre-market applications and monitor the post market safety of all marketed drug products. The incumbent is responsible for directing the work of the team, assigning incoming documents, and providing first level signoff for outgoing documents; is responsible for drug assessments and regulatory mandates. Provides technical and non-technical guidance to internal and external senior level officials and stakeholders, i.e., internal stakeholders include CDER and in other FDA centers and external stakeholders includes regulated industry. Identifies key policy and/or programmatic issues, resolves problem situations, and initiates and/or implement necessary actions.
Physician (Neurologist/Radiologist/Nuclear Medicine)
The Center for Drug Evaluation and Research (CDER), The Office of New Drugs (OND) is hiring a Physician (Neurologist/Radiologist/Nuclear Medicine). As a Physician (Neurologist/Radiologist/Nuclear Medicine), the incumbent will 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.
Detail-Director of Investigations Branch, OBPO, Division II
The Office of Medical Products and Tobacco Operations (OMPTO) is recruiting for a Director of Investigations Branch, OBPO, Division II detailee who will have responsibility for inspections, investigations, compliance and enforcement of medical products and tobacco facilities regulated by the Medical Product and Tobacco Centers.
Director of Investigations Branch, OBPO, Division II
The Office of Medical Products and Tobacco Operations (OMPTO) is recruiting for a Director of Investigations Branch, OBPO, Division II who will have responsibility for inspections, investigations, compliance and enforcement of medical products and tobacco facilities regulated by the Medical Product and Tobacco Centers.
Branch Chief
The Center for Biologics Evaluation and Research (CBER) is recruiting a Brand Chief to serve the Division of Acquisitions and Budget Resources (DABR) Budget Planning and Execution Branch (BPEB) and manage the daily operations of the Branch. As Branch Chief, the incumbent provides comprehensive management and operational activities related to all funding types within CBER. The Branch Chief reports to the DABR Division Director.
Regulatory Counsel
The Center for Drug Evaluation and Research (CDER), Office of Compliance (OC) is recruiting for a Regulatory Counsel to serve as a Subject Matter Expert (SME) with responsibilities for protecting the public health of U.S. consumers from unapproved and misbranded drug products through the enforcement of compliance laws and regulations.
Recruitment Team Lead (Non-supervisory)
The Center for Veterinary Medicine (CVM), Office of Management (OM), Human Capital Management Staff (HCMS) is recruiting for a Recruitment Team Lead (Non-supervisory) to perform day-to-day recruitment activities to ensure that CVM can meet annual hiring goals.
Regulatory Counsel
The Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) is recruiting for a Regulatory Counsel to develop policies and programs involving the most complex and highest priority matters affecting the regulation of generic drug products.
Interdisciplinary Scientist (Pharmacokineticist) (Multiple vacancies)
The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) is recruiting for a Interdisciplinary Scientist, with responsiblity of reviewing and evaluating drug applications and communicating conclusions with a multidisciplinary review team. The work will be performed within any of the pharmacology/toxicology or clinical drug review divisions located within OND.
Pharmacist
The Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) is recruiting for a Pharmacist to provide technical direction to various aspects of the assessment of ANDAs and other generic drug submissions by performing regulatory duties that support the public health mission to help ensure high quality, affordable generic drugs are available to the American public.
General Health Scientist
The Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) is recruiting for a General Health Scientist be responsible for the evaluation of the safety, efficacy, and/or substitutability of generic drugs consumed by the American people.
Biological Scientist
The Center for Biologics Evaluation and Research (CBER), Office of the Center Director (OD), Associate Director for Preparedness and Response Staff (ADPRS) is recruiting for a Biological Scientist to perform the efficient and effective coordination of assigned projects as it relates to the emergency use authorization and related activities within the chemical, biological, radiological, nuclear (CBRN) and/or pandemic flu preparedness efforts.
Regulatory Health Project Manager (Multiple vacancies)
The Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) is recruiting for a Regulatory Health Project Manager to provide technical direction to team members within OGD to support the public health mission to help ensure high quality, affordable generic drugs are available to the American public.
Lead Consumer Safety Officer
The Center for Drug Evaluation and Research (CDER), Office of Compliance (OC) is recruiting for a Lead Consumer Safety Officer to be responsible for leading a team within Compounding Branch 5, Division of Compounding Policy and Outreach (DCPO), Office of Compounding Quality and Compliance (OCQC), Office of Compliance.
Supervisory General Health Scientist
The Center for Drug Evaluation and Research (CDER), Office of the Center Director (OCD) is recruiting for a Supervisory General Health Scientist to manage and lead FDA's efforts to broaden the FDA Opioid priorities in alignment with the Health and Human Services (HHS) Overdose Prevention Strategy and FDA Overdose Prevention Strategy.
Physician
The Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) is recruiting for a Physician to serve as a primary reviewer responsible for the scientific evaluation of clinical studies supporting development and approval of generic drugs. Assesses substitutability for proposed generic drug-device combination products, including assessment of comparative analysis.
Consumer Safety Officer (Band C)
The Center for Drug Evaluation and Research (CDER), Office of Compliance (OC) is recruiting for a Consumer Safety Officer to review recommendations for potential administrative and judicial actions based on adulteration charges under the Food Drug & Cosmetic (FD&C) Act to ensure consistency and adherence to FDA policy. Provides enforcement decision and compliance strategies based on review of evidence of violations, compliance policy, public health risks, and availability.
Consumer Safety Officer (Band D)
The Center for Drug Evaluation and Research (CDER), Office of Compliance (OC) is recruiting for a Consumer Safety Officer to review recommendations for potential administrative and judicial actions based on adulteration charges under the Food Drug and Cosmetic (FD&C) Act to ensure consistency and adherence to FDA policy. Provides enforcement decision and compliance strategies based on review of evidence of violations, compliance policy, public health risks, and availability.
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.
Branch Chief (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 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.
Lead Quality Assurance Specialist
The Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) is recruiting for a Lead Quality Assurance Specialist to serve as a subject matter expert and conducts quantitative and qualitative analyses to ensure efficient and consistent work processes and products across OGD.
Deputy Office Director
The Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) is recruiting for a Deputy Office Director to serve as the primary advisor to the Office Director, providing expert-level administrative, technical, and regulatory support on all matters related to generic drug regulatory authorities.
Associate Director for Science
The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ) is recruiting for an Associate Director for Science to serve as a technical expert and senior advisor to the Deputy and Office Director for the Office of Policy for Pharmaceutical Quality (OPPQ) on matters related to the advancement of policy related to pharmaceutical quality by providing expert scientific experience and extensive knowledge of Federal statutes and regulations.
Data Curation Lead
The Office of the Commissioner, Office of Digital Transformation, Office of Data, Analytics and Research is recruiting for a Data Curation Lead to advance the agency’s strategic vision for applying data curation, strategy, and services, ensuring data quality, managing data life cycles, developing project plans, and guiding execution teams.
Regulatory Counsel
The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) is recruiting for a Regulatory Counsel to serve as an expert in biologic and biosimilar-related policy and will lead, monitor, and review the development and implementation of regulatory policies, standards, and procedures related to biosimilar and interchangeable products.
Dental Officer
The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) is recruiting for a Dental Officer to provide regulatory oversight for investigational studies during drug development and making decisions regarding marketing approval for new (innovative or non-generic) drugs, including decisions related to changes to already marketed products; monitoring the post market safety and effectiveness of medical drug products marked and used nationwide.
Lead Pharmacologist
The Center for Drug Evaluation and Research (CDER), Office of Generic Drugs is recruiting for a Lead Pharmacologist in the Division of Therapeutic Performance II (DTP II), Office of Research and Standards (ORS) within OGD to lead a team of professionals who focus on immediate release of 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 (Pharmacology/Toxicology)
The Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD), Office of Safety and Clinical Evaluation (OSCE), Division of Pharmacology and Toxicology Review (DPTR) is recruiting for an Interdisciplinary Scientists (Pharmacology/Toxicology) to review, evaluate, and determine the approvability of regulatory submissions and applications that request FDA consideration for clinical research, testing, and manufacturing of human drugs and other related regulatory submission specialty areas.
Interdisciplinary Scientist (Pharmacokineticist)
The Center for Drug Evaluation and Research (CDER), Office of Bioequivalence, Office of Safety and Clinical Evaluation, and Office of Research and Standards are recruiting for Interdisciplinary Scientists (Pharmacokineticists) to conduct the scientific evaluation of generic drug products and determines the acceptability of scientific and regulatory applications through the assessment and evaluation of submissions.
Division Director (Division of Biomedical Informatics, Research & Biomarker Development)
The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) is recruiting for a Division Director, Division of Biomedical Informatics, Research & Biomarker Development to provide direction, oversight, and leadership to subordinate staff comprised of multidiscipline reviewers. The review teams are multidisciplinary scientific teams that review and provide consults in relation to biomarker development and regulatory science activities that affect the approvability of regulatory submissions and applications.
Director, Office of Global Operations
The Office of the Commissioner, Office of Policy, Legislation and International Affairs, Office of Global Policy and Strategy, Office of Global Operations is recruiting for a Director, Office of Global Operations to utilize expert knowledge of global health policy, diplomatic and foreign affairs, and Department of State for deployed personnel and provide scientific and technical direction to the foreign offices.