Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Center for Drug Evaluation and Research | CDER

Center for Drug Evaluation and Research | CDER

                        CDER Offices and Divisions
          Meeting Presentations | Drugs
          CDER Exclusivity Board


                        Accelerating Rare disease Cures (ARC) Program
          CDER Contact Information
          CDER Manual of Policies & Procedures | MAPP
          Frequently Asked Questions about CDER
          Reports & Budgets | CDER Home
          About FDA
          FDA Organization
          Center for Drug Evaluation and Research | CDER
          Jobs in Oncology/HematologyCenter for Drug Evaluation and Research | CDER Jobs in Oncology/Hematology
  
  					Transformative careers in FDA Oncology
	
    Share
    Post
    Linkedin

    Email
    PrintWho We Are


What We Do


Join Us

FDA is recruiting oncologists and hematologists to serve in the dynamic, highly challenging, and innovative atmosphere of oncology drug development and research.

Who We Are

Meet Dr. Nicole Gormley, Division Director of Hematologic Malignancies 2, as she
discusses what’s satisfying about the work she's doing in the multiple myeloma field at FDA Oncology.

The Office of Oncologic Diseases (OOD) consists of oncologists from all career backgrounds, stages, and fields of expertise, including medical, surgical, pediatric, radiation, and hematologic oncologists. There are five divisions of therapeutic areas and one nonclinical division within OOD.

We may spend up to eight hours weekly seeing patients in clinic to maintain our clinical skills. Area oncology centers include Johns Hopkins, Sibley Memorial Hospital, University of Maryland, George Washington University, Georgetown University, National Cancer Institute (NIH), Veterans Administration (VA), and Walter Reed National Military Medical Center.

Who We Are: Early, Mid, and Late-Career Oncologists and Hematologists - Oncology Center of Excellence
FDA oncologists trained and worked at various academic centers throughout the country. A few of the institutions include:

Children’s Hospital of Philadelphia
	Johns Hopkins Sidney Kimmel Cancer Center
	MD Anderson Cancer Center
	Memorial Sloan Kettering Cancer Center


National Cancer Institute
	University of Chicago
	Vanderbilt University Medical Center
	and many more

What We Do

As oncologists and hematologists at the FDA, we engage researchers, patients, global regulators, and educators in a multifaceted approach to improve cancer care. Our commitment to public health, collaboration, and patient-centered regulatory decision-making drives our passion for advancing the availability of safe and effective drugs and biologics to patients with cancer. This manifests in the following six areas of activity.

Regulatory Review

Regulatory review, beginning from early phase development and extending past marketing approval, is foundational to our work. We identify ways to improve the risk/benefit profile, provide advice on trial design, and critically assess clinical benefit within each disease context.
Learn more about Investigational New Drugs (INDs) and Project Facilitate, a pilot program to assist oncology healthcare providers or regulatory professionals in requesting access to investigational therapies for patients with cancer.

Still curious? Read the Top 10 Myths About FDA’s Office of Hematology and Oncology Products.

Research

We are very active in research. An analysis of recent oncology scientific publications revealed that our papers are enriched for high-impact publications, and have nearly two times the number of citations as an average NIH-funded paper. FDA oncology staff has contributed to numerous publications in scientific literature which can be found in PubMed including *The New England Journal of Medicine, Lancet Oncology, Nature Reviews Clinical Oncology, Journal of Clinical Oncology, JAMA Oncology,* and more*.*

Education

Project Socrates
Through open communication, education, and outreach, we aim to provide transparency and insight into the FDA’s role in oncology drug development, and the multidisciplinary and team-based approach the FDA takes in this process.

Read more in the ASCO Post article and learn about Project Socrates, one of the many Oncology Center of Excellence (OCE) initiatives.

Community Engagement

**Local engagement with the community:** The goal of Project Community is to introduce the work of FDA oncologists and hematologists to the community. This includes cancer survivors, patients, advocates, families and others in underserved or under-represented urban and rural communities who live with heightened cancer risk communities.

**Engagement with international regulatory agencies:** As a result of cancer drug development being global, Project Orbis provides international access to safe and effective drugs earlier through concurrent submission and review of oncology products.

**Engagement with patients, caregivers, and their healthcare providers:** Project Patient Voice is patient-reported symptom data collected from clinical trials. The data will be available in an online interactive platform to help patients, and their healthcare providers, understand the patient experience, risks, and benefits of a drug.

Regulatory Policy

Between June 2018 and June 2019, FDA Oncology released 22 Guidances for Industry*, on topics ranging from cancer clinical trial eligibility criteria, to regulatory considerations for use of minimal residual disease in hematologic malignancies, to clinical trial endpoints for the approval of cancer drugs and biologics.

*Guidance documents represent FDA's current thinking on a topic, describing FDA's interpretation of our policy on a regulatory issue.

Professional Development

At the FDA, we can further develop our career with pursuits in research or clinical care. Some of us continue to see patients for up to 8 hours a week in a variety of clinical settings such as precepting fellows, second-opinion clinics, continuity clinics, and inpatient medicine in academic, community, or government facilities. We also engage in many research activities, and we publish original research, review articles and commentaries, approval summaries for drugs we approve for marketing, and expert working group reports.

**Join Us

Whether you are just starting out of training, or ready for a career change, we would love to connect with you!

Contact FutureofHemeOnc@fda.hhs.gov if interested in job opportunities or to learn about benefits such as loan repayment and 1:1 matching for government retirement contributions.
	Learn about the Quality of Worklife at FDA, including benefits and flexible telework options.
	And join our community on the X platform @FDAOncology!

                                                                                  Content current as of:
      08/09/2023
              
              
Regulated Product(s)
		 Drugs
			  			     			  						              
			
			
			
			
						  OncologyCenter for Drug Evaluation and Research | CDER

          
                        CDER Offices and Divisions
          Meeting Presentations | Drugs
          CDER Exclusivity Board


                        Accelerating Rare disease Cures (ARC) Program
          CDER Contact Information
          CDER Manual of Policies & Procedures | MAPP
          Frequently Asked Questions about CDER
          Reports & Budgets | CDER
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop