theMednet Job Series: FDA
Did you know that you can start your oncology career at the FDA? It typically requires a personal connection and some serendipity to find out what the FDA has to offer for oncologists. That's why we at theMednet sat down with a few current and former FDA physicians working in various roles in the Office Oncologic Diseases (OOD/CDER) to help hematology and oncology fellows and radiation oncology residents decide if the FDA is right for them!
Here are a few of many factors to consider when looking to apply to the FDA's oncology program; some are unique to the institution, some are potential hurdles and challenges, and many are the surprising benefits!
"The F stands for Family"
Despite being a government institution, the FDA provides one of the greatest lists of flexibilities in terms of work hours, vacation, overtime, and putting family first. It's often said between coworkers that the F in FDA stands for family! Starting in October 2020, federal employees will have access to 12 weeks paid parental leave if they have worked at a federal institution for at least one year.
Working at the FDA provides a more predictable and flexible work schedule. While it is not uncommon for the oncologists at the FDA to need to do additional work after hours, in the federal government, 40 hours is considered a full-time work week, which is unusual in other oncology jobs. Additionally, as it is a federal institution, employees don’t work on holidays. When possible, most meetings are scheduled during so-called “core hours”: Monday through Friday between approximately 10am-3pm, which provides greater flexibility for those who prefer to shift their workday earlier or later to accommodate parenting or other non-work-related responsibilities. Many employees continue to see patients and/or perform scholarly work through a separate academic affiliation.
There is also an option to telework at the FDA. In fact, most oncologists work at least one day from home. After six months, there is an opportunity to work from home two days out of the week. Plus, a laptop and other equipment needed to work from home are provided.
Career Advancement at the FDA
There are a multitude of tracks and positions offered at the FDA, so we're going to highlight a few noteworthy paths. Dr. Tatiana Prowell, a medical oncologist who serves as a clinical reviewer and Breast Cancer Scientific Liaison in the Office of Oncologic Diseases at the FDA, and is an Associate Professor of Oncology in the Johns Hopkins Breast Cancer Program, speaks about the scientific liaison program:
"Scientific liaisons are subject matter experts in tumor types or drug-development topics, such as immunotherapy, breast cancer, etc. In this role, we are outward-facing, so we interact with the rest of the oncology world in our topic areas, including advocacy organizations, professional groups like ASCO and AACR, cooperative groups, and so on. We serve on committees, teach at workshops, work with patient advocates, attend and speak at conferences, and lecture at academic centers and other organizations. While all scientific liaisons still perform their core regulatory work, the program offers experienced FDA clinical reviewers an alternative to the traditional leadership track within the divisions under the Office of Oncologic Diseases."
Dr. Nicole Gormley, who works as an acting Division Director for Hematologic Malignancies II at the FDA states: "Our divisions are always looking for more people; it's really a growing organization overall. Whether it's becoming team leader, a division director, or a scientific liaison, there are always opportunities to move up with chances to get involved in other areas, such as policy." Most importantly, the FDA is an ocean of scientific resources, and for people who are willing to explore FDA’s massive datasets from completed clinical trials in oncology, the range of feasible research opportunities is massive. It's worth noting that there is a higher demand for medical oncologists or hematologists, as there is a greater overall need for clinical reviewers.
Many oncologists will work as clinical reviewers in the Center for Drug Evaluation and Research, and apply their clinical knowledge to the evaluation of drug safety and efficacy. "They ensure all human drugs manufactured for interstate sale are safe and effective with truthful and informative product labeling; ensure the safety, potency, purity and effectiveness of vaccines, blood products, certain diagnostic products and other biological and biotechnology-derived human products; and ensure the safety and effectiveness of medical devices and eliminating unnecessary human exposure to manmade radiation from medical, occupational and consumer products," per the FDA career descriptions site.
What type of physician should choose the FDA?
It takes a certain type of person to work at the FDA, and many will note that a great deal of the work happens behind the scenes. Dr. Prowell informs us, "I've learned working here that you have to have a thick skin. We get a fair amount of public criticism, so you have to be comfortable with that, to be content with the idea that you are doing the best you can with the data you have at the time. You have to make decisions for populations with, in many cases, a lot of unmet medical need." She continues, “It’s a good environment for people who are devoted to the mission of public health and believe in team science. There are fewer opportunities for individual ‘glory’ so to speak, compared with academia.” Indeed, the many drug development programs FDA reviewers have provided advice on and drugs reviewed by FDA staff seldom have the oncologist's name publicly associated with them.
That said, Dr. Prowell continues, "we're in a unique position to ask and answer questions no one else can. The nature of our work demands a lot of data, and that is data only we have access to in such large quantities. If you are curious and make the time to do it, there are a lot of opportunities for independent research using existing datasets to answer clinically and scientifically very important questions." If you're a team player who is both curious and innovative, the FDA may be right for you. This institution offers you a chance to impact drug development at the highest level and make a huge impact on cancer care and public health.
Dr. Amanda Walker, a radiation oncologist, former clinical reviewer, and Associate Director (Acting) for Radiation Oncology at the FDA's Oncology Center of Excellence—who now works as an Assistant Professor of Radiation Oncology at Johns Hopkins—says the FDA is a place where, "creatives thrive. Everyone there is acutely aware of cutting edge technology and what's happening in their fields. If you're patient enough to see a project through, and are okay with digging into data, you'll make a lasting impact there." Such projects may not be as clear cut in a traditional academic setting. The nature of research projects is less well-defined at the FDA than in academic settings, where conducting clinical trials is the most common scholarship currency for medical oncologists. As a result, you will find that thoughtful, meticulous self-starters thrive here.
Plus, there is no having to deal with the pressure of grant writing and other similar pressures you may face at academic institutions. Dr. Gormley explains, "The environment feels different here, more collaborative. If you want to start a project, you just do it."
What are the benefits?
As previously stated, the FDA is a great option for fellows and residents interested in doing original research. They have access to unimaginable quantities of patient-level data in clean datasets, and it doesn't require additional funding or permission outside of employment to use it, as long as you're motivated to ask questions that need answering. "It's really a great bird's eye view of what is happening in oncology, and where radiation oncologists fit into that. I've felt like the barriers were broken down for collaboration with other oncologists. I also gained a greater appreciation for how a drug comes to market," Dr. Walker says, while adding the job security at a federal institution is a comforting aspect as well.
Continuing on the theme of the collaborative spirit at the FDA, Project ORBIS, an initiative of the FDA Oncology Center of Excellence (OCE), allows for a previously unseen level of teamwork with international institutions and partners. "The project has been a way for us to coordinate on review of applications and work closely with international agencies. I've really appreciated the positive environment and culture both within the project and in my own oncology division," Dr. Gormley states.
Above all, it's the rewarding nature of the work that FDA employees overwhelmingly cite as the best part of working there. Dr. Gormley continues, "reviewing products and advising sponsors on trials allows you to have such a huge impact on drug development. There have been so many new products approved for multiple myeloma since I came to work here in 2011. I've become really engaged with the academic community in terms of drug development. We often get to publish guidances on the development of endpoints." Dr. Prowell notes the extensive footprint of FDA oncologists in the research world: "Our FDA colleagues can be found at the podium in every major scientific conference and are publishing in high-impact journals. In fact, a recent analysis found that publications from the FDA’s oncology program were cited nearly twice as often as publications of NIH-funded research being conducted in academic centers.”
Most agree that in addition to the successful careers many are leading over the long-term at the FDA, a stint at the FDA also has the potential to serve as a stepping stone to other high-profile career opportunities in oncology. Some physicians have noted their work at the FDA has led to offers of prominent roles in drug development in academia or industry and other institutional leadership roles, at multiple major US cancer centers.
What challenges should I expect?
FDA oncologists have been underpaid historically, lower than academic salaries for similar years of experience. A June 2018 21st Century Cures report to Congress noted that FDA medical officers were compensated at 46% below market value. Under the current model, loan repayment programs provide up to $10,000 in compensation per year for up to six years, in addition to salary. There is hope that this financial challenge of recruiting and retaining oncologists to the FDA will finally be changing due to the recently passed 21st Century Cures Act, which brings with it changes in pay structure.
It's also worth noting that Federal employees are held to extremely strict standards when it comes to conflicts of interest: no holding stock in pharmaceuticals, or any product regulated by the FDA, including food, drugs, and cosmetics. There are many restrictions on what you can accept as gifts as well, including honoraria and other outside compensation. Speaking and other professional development opportunities may be prohibited if the source of the invitation is in industry or otherwise poses a real or perceived conflict of interest. All these need a supervisor's approval, and possibly ethics approval, before proceeding.
While some oncologists at the FDA moonlight as hospitalists, cover inpatient oncology services, or otherwise continue to practice clinically, it's usually limited to eight hours per week, which can be problematic for oncologists craving more patient care. Those who choose to stop seeing patients may find it difficult to transition back into a clinical role upon deciding to move on from the FDA. A question worth asking is: how much clinic do you want and how much can you tolerate not having? Additionally, there is a niche and sometimes limited role for radiation and surgical oncologists at the FDA.
Many also don't consider how acutely the federal government dictates life at the FDA. When the most recent lengthy government shutdown occurred, some FDA oncologists couldn't do their professional development at area clinics for the duration of the shutdown. Others were forced to back out of speaking commitments at conferences on short notice. While their work is deemed essential at the FDA, oncologists may generally only work on applications funded by PDUFA during those times. The hiring process for government employees can also be lengthy. Federal jobs can, in some cases, take up to a full year to complete the entire application and interview process, so it’s important to start the interview process early!
Working at the FDA is a unique opportunity that offers many benefits to clinicians interested in a rewarding non-traditional career path. To find out more about how you can become a part of the mission to protect and secure the health of the American public, you can check out the FDA's general careers page here, follow job posts on their Twitter, and additionally email FutureOfHemeOnc@fda.hhs.gov for information on salary, benefits, position description and application procedures.