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
Branch Chief
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. The Branch Chief guides 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). The incumbent will serve as 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.
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). The Physician 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.
Deputy Division Director (Pharmacokineticist)
The Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) is recruiting for a Deputy Division Director (Pharmacokineticist). As the Deputy Division Director, the incumbent serves as the alter ego to the Division Director in the oversight, leadership, and management of the division. This includes aiding in the management and direction of the regulatory science and technical support activities on all matters related to chemistry, pharmacology, pharmacokinetic, modeling, simulation, and analytical tools used in the assessment of generic drug products.
Interdisciplinary Engineer
The center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ) is recruiting for an Interdisciplinary Engineer. As an Interdisciplinary Engineer, the incumbent serves on multi-disciplinary scientific teams providing technical leadership and guidance in research designed to resolve specific scientific issues to support regulatory assessment, policy development, and decisions.
Interdisciplinary Scientist (Biologist, Pharmacologist/Toxicologist)
The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) ia recruiting for an Interdisciplinary Scientist (Biologist, Pharmacologist/Toxicologist). As an Interdisciplinary Scientist (Biologist, Pharmacologist/Toxicologist), the incumbent is responsible for reviewing and evaluating drug applications and communicates conclusions with a multidisciplinary review team.
Deputy Office Director
The Office of Clinical Policy and Programs (OCPP), Office of Orphan Products Development (OOPD) is recruiting for a Deputy Office Director. The incumbent serves as Deputy Director of OOPD, representing senior management in scientific and regulatory matters and provides direction, coordination, and leadership in areas related to orphan drugs and rare diseases.
Lab Chief
The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ) is recruiting for a Lab Chief. As the Lab Chief, the incumbent serves as a senior advisor to a Division Director or Deputy Director and plans, manages, organizes, and directs all laboratory functions, surveillance testing, and laboratory-based investigational activities as carried out by a highly trained and skilled staff of scientific professionals.
Industrial Hygienist
The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ) is recruiting for a Industrial Hygienist. As an Industrial Hygienist, the incumbent serves as an advisor to OTR Leadership and staff to identify potential safety concerns with work performed in laboratory and pilot plant facilities designed to conduct research using chemicals and equipment to manufacture and test pharmaceutical products and ingredients.
Social Scientist
The Center for Drug Evaluation and Research (CDER), Office of Strategic Programs (OSP) is recruiting for a Social Scientist. As a Social Scientist, the incumbent supports the conceptualization, design, and conduct of complex studies into any aspect of the operation and management of programs and/or processes within the Center.
Director, Center for Veterinary Medicine (CVM)
The Center for Veterinary Medicine is recruiting for a Director to provide overall leadership and management for the Center, coordinates and works to integrate CVM programs with those of the other FDA Centers; serves as a liaison between FDA and other government agencies, academic institutions and private organizations; and is responsible for the direction, performance and quality of CVM's programs and activities.
Regulatory Counsel
The Center for Drug Evaluation and Research (CDER), Office of Compliance (OC) is hiring a Regulatory Counsel. As a Regulatory Counsel in the Office of Drug Security, Integrity, and Response (ODSIR), Division of Supply Chain Integrity (DSCI), the incumbent serves as an expert in the statutes, regulations, policies, procedures, and implications relevant to the issuance of FDA regulations, conducts sophisticated analyses of complex regulatory and policy issues for CDER supply chain security program areas and leads policy development activities. Provides advice to staff in CDER in carrying out its regulatory mission.
Deputy Office Director
The Center for Drug Evaluation and Research (CDER), Office of Compliance (OC) is recruiting a Deputy Office Director. As the Deputy Office Director for the Office of Program and Regulatory Operations (OPRO), the incumbent serves as the principal advisor to the Office Director and supports in the oversight and management of the operational infrastructure relating to project management, process management and regulatory strategy for compliance and enforcement activities and associated drug safety monitoring conducted by the CDER OC.
Informatics Program Manager
The Center for Drug Evaluation and Research (CDER), Office of Strategic Programs (OSP) is recruiting for an Informatics Program Manager. As an Informatics Program Manager, the incumbent will support the planning and execution of major technology programs consisting of multiple projects.
Clinical Analyst
The Center for Biologics Evaluation and Research (CBER), Office of Tissues and Advanced Therapy (OTAT), Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), Malignant Hematology Branch (MHB) is recruiting a Clinical Analyst. The incumbent will serve as the Clinical Analyst in the Malignant Hematology Branch (MHB), DCEPT, OTAT and reviews clinical regulatory submissions for the Division. This position reports to the MHB Branch Chief.
IT Specialist (UX/UI Designer)
The Office of the Commissioner (OC), Office of External Affairs (OEA), Web & Digital Services Staff (WDSS) is recruiting an IT Specialist (UX/UI Designer). The incumbent will serve as a senior Information Technology Specialist and must be proficient with human-centered design (HCD) practices, user interface (UI) design and related functions, and user experience (UX) leadership. The incumbent will be instrumental in providing advice and technical support for web and digital staffs across FDA. This role involves interpreting complex medical and scientific information that result in public facing messaging on our FDA.gov website and other digital communications channels.
Physician (Chief Medical Officer)
The Center for Devices and Radiological Health (CDRH), Office of Product Evaluation and Quality (OPEQ), Office of Health Technology III (OHT3) is recruiting a Physician (Chief Medical Officer). The incumbent will report directly to the Office of Health Technology 3 (OHT3) Office Director, serve as program manager and primary contact for medical device clinical issues and as a Chief Medical Officer advisor to the Office Director, Super Office Director, and other OPEQ and CDRH leadership. Also, the incumbent provides senior advice and leadership to a scientific, clinical, professional, and technical staff throughout the Office. The Chief Medical Officer is a nationally and internationally recognized clinician with a specialty emphasis on clinical trial design and evaluation, and quality control procedures.
Division Director
The Center for Drug Evaluation and Research (CDER), Office of Translational Sciences (OTS) is recruiting a Division Director. As Division Director of Division of Biometrics IX (DBIX), Office of Biostatistics (OB), Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER), the incumbent is responsible for providing leadership on statistical reviews of regulatory submissions on malignant and non-malignant hematology products.
Interdisciplinary Scientist (Pharmacologist/Toxicologist)
The Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) is recruiting an Interdisciplinary Scientist (Pharmacologist/Toxicologist). As an Interdisciplinary Scientist, the incumbent reviews, evaluates, and determines 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. The Interdisciplinary Scientist will conduct research and utilize and communicate an expert understanding of current concepts in pharmacology, toxicology, and FDA policies and regulations throughout the review process.
Computer Scientist
The Center for Drug Evaluation and Research (CDER), Office of Strategic Programs (OSP) is recruiting a Computer Scientist. As a Computer Scientist, the incumbent works 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.
Interdisciplinary Scientist (Pharmacokineticist)
The Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) is recruiting an Interdisciplinary Scientist (Pharmacokineticist). As an Interdisciplinary Scientist (Pharmacokineticist), the incumbent conducts the scientific evaluation of generic drug products and determines the acceptability of scientific and regulatory applications through the assessment and evaluation of submissions.
Pharmacokineticist
This Interdisciplinary Scientist position is in the Office of Clinical Pharmacology (OCP), Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA). The incumbent will serve as a Pharmacokineticist for the Division of Cancer Pharmacology I or Division of Cancer Pharmacology II in the Office of Clinical Pharmacology.
Physician
The Center for Drug Evaluation and Research (CDER), Office of Compliance (OC) is hiring a Regulatory Counsel. The incumbent serves as a physician reviewer on an assigned team and reports to the Branch Chief of the Good Clinical Practice Assessment Branch within OSI’s Division of Clinical Compliance Evaluation (DCCE).
Assistant Commissioner for Criminal Investigations (ACCI)
FDA’s Office of Regulatory Affairs (ORA) an Assistant Commissioner for Criminal Investigations (ACCI) to serve as the principal advisor to the ACRA and other key officials on regulations and criminal matters that affect the Agency and provides the executive leadership and technical direction in initiating and conducting criminal investigations under all statutes administered by the FDA through Offices located throughout the United States.
Regulatory Counsel
The Center for Drug Evaluation and Research (CDER) is recruiting a Regulatory Counsel. As a Regulatory Counsel in the Divisions of Regulatory Policy (DRP) I-IV in the Office of Regulatory Policy (ORP), the incumbent is 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.
Associate Director for Quality Management
The Center for Drug Evaluation and Research (CDER) is hiring an Associate Director for Quality Management (ADQM) who will serve as an advisor for the Director and Deputy Director of the Office of Study Integrity and Surveillance (OSIS), providing expert level advice on matters pertaining to stakeholder interactions encompassing the strategic development and enhancement of external relationships with the scientific, academic, and industry communities, arising from on-going and new CDER goals, policies and initiatives within the Office of Study Integrity and Surveillance.
Director of Investigations Branch (DIB)
FDA’s Office of Regulatory Affairs (ORA), Investigations Branch (DIB), Office of Medical Products and Tobacco (OMPTO) is hiring a Director. The incumbent will direct the formulation and recommendation of plans and participates with the Program Division Director in the establishment of goals and priorities in his/her assigned area.
Consumer Safety Officer
The Center for Drug Evaluation and Research (CDER), Office of Compliance (OC), Office of Unapproved Drugs and Labeling Compliance (OUDLC) is hiring a Consumer Safety Officer. As a Consumer Safety Officer in the Office of Unapproved Drugs and Labeling Compliance (OUDLC), the incumbent serves 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.
Regulatory Counsel
The Center for Drug Evaluation and Research (CDER), Office of Compliance (OC) is recruiting a Regulatory Counsel who will be responsible for providing regulatory, legal and policy matter expertise to advise and support a program function within The Division of Compounding Policy and Outreach (DPCO) and within The Office of Compounding Quality and Compliance (OCQC).
Super Office Director
Office Director for the Office of Therapeutic Products (OTP) under the Center for Biologics Evaluation and Research (CBER) is hiring a Super Office Director to manage the Super Office. This position reports to the Director of CBER. The Super Office Director oversees the planning, development, and direction of strategies and actions that are patient-focused and risk-based to secure the safety, efficacy, and quality of the nation’s cellular, tissue, gene therapy (including viral and non-viral vectors), therapeutic vaccines, and plasma-derived and coagulation products as well as associated medical devices.
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.
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.
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.
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.