This article was originally published by Nicole Castagnozzi
Please tell us about your work
Undergraduates who are looking for a career that will positively impact human health are likely aware of two general career paths: basic science researcher, and health care professional. Basic science researchers help improve the understanding of disease and participate in the initial discovery stages of treatment development, while health care professionals are doctors, nurses, physicians assistants, or others who actually administer the treatments to patients. However, there’s a lot of work that goes into developing the potential discoveries of research scientists into approved and effective treatments that can be administered in hospitals. Rigorous clinical trials are a crucial bridge connecting basic research to actual real world human health outcomes. To get some insight on what it’s like to have a career in this important bench-to-bedside bridge area, I spoke with Emily Stone, who has been working in clinical trial management since her graduation from University of Rochester in 2009. Emily earned her BS from U of Rochester in Brain and Cognitive Science, and earned her MBA from Babson in May 2017. She is currently a clinical trial manager at a small startup in Waltham, Massachusetts.
How did you end up in such an offbeat, unconventional and exciting career?
Emily initially started as an undergraduate at the University of Rochester majoring in Biomedical Engineering (BME). After about 18 months, she realized that it wasn’t the right field for her and made the switch to Brain and Cognitive Science (BCS). “I was just not happy, wasn’t having fun [with BME]”, she says, and ultimately chose to major in BCS because while she wanted to stay in science, she explains that she found the ‘granular’, detail-focused nature of BME to be a bit dry. She felt BCS was the most interesting science and she knew it would give her a lot of options after graduation. “BCS can be artificial intelligence, brain surgery, marketing, a lot of options,” she says. In the end, it turned out that a job she had as an undergraduate really prepared her for the career she has continued in since graduating. Emily was hired as a Research Assistant at Strong Memorial Hospital, which is associated with the University of Rochester, working on autism and down syndrome studies in the pediatric department. “I found that job because I started applying for anything I thought I was remotely qualified for. Even if I didn’t meet all the requirements, but some of them, I applied, because you don’t get what you don’t apply for,” she says. While the work wasn’t exactly brain and cognitive science, it was her first experience working in clinical trials and it turned out to be extremely valuable experience that helped her find a job after graduating. “I was doing data entry and learning about what clinical research is,” she says of her time at Strong Memorial Hospital. Thanks to that experience, when Emily graduated she already had a skillset that made her qualified for positions working in clinical trials that she was interested in.
How did the BSC major help you?
I asked Emily to elaborate on how a BCS major could help with a career in Robotics. University of Rochester actually offers a specialization in Artificial Intelligence within the Computer Science major offered at Emily’s school. On the University of Rochester website, studies in this specialization include “work on knowledge representation and reasoning, machine learning, dialog systems, statistical natural language processing, automated planning, AI-based assistive technology, and computer vision”. Although she did not choose that major, she did take programming classes and thinks the field of AI is very exciting. “At the time I didn’t understand the breadth of what AI could do, all of its capabilities,” she says. “I think one of the biggest takeaways is that we know a pretty good amount about the human body but when you get to the brain, we only know a very small percentage about how the brain functions… There are so many things we could learn about how our own brains work and how we think and process information, because we make split second decisions that are easy for us but difficult to communicate in a programming language. How to teach a machine to tell the difference between a small child and a rolling ball, for example”, she explains. Therefore, having background in neuroscience, some understanding of how human brains work, “could inspire how we program machines”.
Tell us about your career path in Clinical Trials Management
Her first job after college was in the TIMI group (Thrombolysis in Myocardial Infarction) at Brigham and Women’s hospital which she describes as “an academic research organization for cardiology clinical trials.” TIMI has a network of physicians around the country and they work with sponsors, usually large pharmaceutical companies, to help set up clinical trial sites up and keep them running. “That job gave me a foundation of knowledge about what it takes to start up a clinical trial, to get a site going,” says Emily. During her time as part of the TIMI group, she was involved in ensuring sites had all the documentation they needed and what guidelines needed to be followed– basic regulations that are fairly common across all clinical trial work.
After about a year in the TIMI group, she moved to a different position within Brigham and Women’s Hospital at the Center for Clinical Investigation. This new group was an all purpose group of in-house clinical program managers. In this new position, there was a lot of variety in the work. “Instead of working in one department, we were working across multiple departments”, she says. “Physicians could say I need help screening patients for a trial, or I need help submitting IRB paperwork, or collecting drug samples, or collecting mitral valve tissue during open-heart surgery– Anything they needed, we would do it”.
She was also able to attend training courses on good clinical practices, how to properly conduct studies, draw blood, build electronic database capture systems, and more. The broad exposure made the work fun and she was happy with the position for a while. Eventually though, it was time to move on; “I just didn’t feel like there was a career track from research coordinator”, said Emily. She explained that many people in the role are in an in-between area career wise – whether they are waiting to get into medical school or MPH (Masters in Public Health) programs, or just getting ready to make a shift career wise — and that the group had a lot of turnover. Although she knew she wanted to go back to school, she wasn’t sure what she wanted to study yet, so she decided instead to make the transition to industry.
Emily soon found a role at a small company through a contact she made at a career fair. “That was a great opportunity– it was a good company to work for, had good business practices, the people were really welcoming and that’s where I learned what it meant to work for a sponsor of the clinical trial, to provide oversight of the trial, hire vendors, how to make sure the trial is ready for regulatory agency inspection, how to get new drug approved”, she says. In this role, she had the rare opportunity to follow a single drug all the way through the development process and see it approved for use by the FDA. “When I started I was supporting four global phase 3 programs [large multinational clinical trials]. Those programs were 50% of the way through startup when I joined, so I got to see them through startup, enrollment, closeout, and there was even a new drug application (NDA) for the compound. So I saw the product all the way through FDA and European agency inspections. It’s unusual to see a drug all the way through trial, to inspection and approval… It was a really neat experience”, she says. The success of the company led to its acquisition by a large pharmaceutical company– at which point Emily decided it was time to move on again.
This time, the company was not as successful. She moved to a small oncology company that had only one drug candidate in clinical trials, and the drug did not work as expected. “There was no more funding and I got laid off,” she says. She then moved to another small oncology company, and a similar situation happened. They were not able to get adequate data to prove efficacy for their drug candidates, funding dried up, and she was laid off. After those experiences, she moved away from the oncology space and is now working at a startup that develops drugs to treat infections. “I’m managing multiple trials and overseeing a much wider scope of activity”, she says.
What are the challenges that you have faced?
While it can be intimidating to change jobs, Emily took calculated risks with moving to new companies when she felt the time was right, and has been able to work in clinical trial management positions with an increasing amount of responsibility and compensation. Through this progression she was also able to gain experience in all aspects of clinical trial management, which has helped her become knowledgeable about all the steps involved and put them into the overall context of moving a drug through a trial, inspection, and approval. “As I’ve progressed in my career I’ve learned about different aspects of running a trial… And I’ve been able to develop that knowledge. Now, where I’m the one making decisions, I think more about, ‘how do I select the right vendors and get financed? And how does this fit into the overall strategy of the company?’”, she explains.
The challenge with drug development is that many drugs don’t work and don’t make it all the way through to FDA approval, and funding is often contingent upon the success of the drugs. As Emily experienced, this type of work can be unstable and it’s not uncommon for companies to lay off entire groups, or large percentages of their workers after a candidate fails. She states the work can also be tedious because everything needs to be documented properly, and if it’s not documented, “it’s like it didn’t happen”.
Like all jobs, clinical trial management has its problems, but there are plenty of upsides to this career. Emily’s favorite thing about the field is that she feels there is a great opportunity to have an impact on a patient’s life. “We have new products and new technology and are always addressing an unmet medical need. I also like that there are different challenges every day, which is exciting”.
Your advice to students?
As for what it takes to excel in this career path, she cites organization skills, an outgoing personality, good general managerial skills, and an ability to balance attention to detail with big picture perspective. Emily explains, “If you get too bogged down in details, you’ll make a process so complex that no one can follow or comply with it, it’s too specific. It’s important to keep a balance, be logical, and to not forget about the operational aspect… I always try to pretend that I am at a site reading the manual and that I have to follow it – do I know what to do? Who to contact if I have trouble?”
Emily has had a fruitful career so far helping clinical trials programs function and serve their purpose as a bridge from bench research to bedside medicine. This is an area with a lot of job opportunities as research continues to progress and new drugs are developed, and it’s worth considering as a potential option for new graduates of the basic sciences.