A View of the Medical Monitor Role in Large Pharma
Dr. Vesper Ramos is a neurologist with a specialty in movement disorders. She works for a large, public pharmaceutical company in Clinical Development. Her clinical development role is focused on later phase clinical research (phase 2b-4).
Vesper moved to the United States to complete her residency because she knew she wanted to work in clinical research and that was not a major option for her in her home country, the Philippines. During residency, she realized that the demands of clinical responsibilities did not allow for much time or energy for research so she sought the most protected research time she could find; at the NIH. At that time, for movement disorders, it was the only fellowship with protected research time.
During her time at NIH she was exposed to so many different aspects of research, including working on a biorepository and clinical trials. Vesper describes “working very lean” and as lead associate investigator she did all the paperwork and legwork for most of the studies she had primary responsibility. Those responsibilities included: recruiting patients, analyzing data, learned and utilized statistics to cross-check the statisticians.
“The energy and enthusiasm (at NIH) for research was great”
Her main fellowship project was in developing a technology of transcranial magnetic stimulation as a diagnostic test for dystonia. “I failed miserably and we halted the study after interim analysis”. Vesper reflected on sage advice she received from a mentor: “don’t worry about the project being a failure. If anything, it makes you more trustworthy as a collaborator and a veteran in the eyes of colleagues”.
Vesper’s experience with that device trial led to her role at the FDA – they were recruiting a neurologist with device experience. At FDA she was involved in the review of medical devices and ultimately recruited to the large pharma company where she is now, again related to her specialty and device experience.
In her current role she serves as medical monitor and clinician. The typical day includes making sure studies are running well and plans for future studies are moving forward. This means a lot of emails, meetings, team messages. She authors protocols, informed consent documents, case report forms, clinical study reports and responses to regulatory authorities. She is also involved in vendor selection and site selection. Other responsibilities include reviewing data for safety, reviewing protocol deviations, data listings, audit findings and statistical analysis plans. If personnel at the clinical trial sites have questions she engages with them in discussion.
“It has been humbling to see how many things go into product development and I don’t think I would have learned these if I stayed in academia as a Principal Investigator.”
Vesper has also experienced competition within teams and believes the best leaders are those that can organize and motivate employees such that this competitive nature is healthy and benefits everyone. Work can be competitive but also highly collaborative. “True collaboration, not just the flashy press release type, but the ones that really produce strong work is a lot of fun”.
I asked Vesper what the qualities of physicians that make a good fit for pharma industry: Team players are critically important; almost everything we do is part of a team. A certain humility is also important – while we are experts in clinical matters, we have less experience and training in other functions that need to be considered like drug supply, regulatory, local practices. It is important to be able to dialogue and see things from different vantage points, even if you don’t necessarily agree with a specific point of view.
Her final words of wisdom for physicians considering the career transition to industry: