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From the Bench to the Pharmacy: The Life of a Clinical Research Scientist in Drug Development


Clinical research is an exciting, fast-paced career that is perfect for those who are interested in applying new basic science and technology discoveries to human health and treatment of disease. Career opportunities in clinical research and drug development encompass a variety of positions and specialty areas, including: medical monitors, clinical research associates, project managers, medical writers, data management, statisticians, manufacturing, regulatory, and pharmaceutical development.

These positions are typically filled by individuals with a variety of backgrounds, such as medicine, nursing, basic science, engineering, pharmacy, statistics, computer science, patent law, and business. The diversity of training and positions coalesce to achieve the common goal of bringing safe and effective new therapeutic products into the marketplace as efficiently as possible.

My interest in science and technology originated from my exposure to medicine at an early age, with a father and mother trained in medicine. Although I have bachelor's degrees in mathematics and computer science, my early exposure to medicine spurred my decision to pursue a graduate degree in physiology. It was during my 4-year experience as a doctoral student in the physiology program at Penn State University that I initially considered pursuing a career in clinical research. Working at an NIH-sponsored General Clinical Research Center, my work involved testing basic science hypotheses in research studies involving human volunteers. I enjoyed interacting with nurses, doctors, fellow graduate students, and especially the volunteers. It was at Penn State that I had my first interaction with an Institutional Review Board and became aware of regulations protecting human subjects.

After I finished my Ph.D., I was undecided as to whether I should pursue a position with a pharmaceutical or biotechnology company or remain in academia. Therefore, I accepted a 2-year postdoctoral fellowship at Johns Hopkins University in the biomedical engineering department. Despite the fact that I had an exceptional 2-year experience performing benchtop research in relatively applied areas of cardiovascular and endocrine physiology, I felt something was still missing--the clinical research setting. I wanted a career where I could see the scientific discoveries made at the bench applied to human health and treatment of disease. Therefore, I actively investigated careers in clinical research, including positions at pharmaceutical companies, government agencies, and contract research organizations (CROs). This search resulted in my current position at a CRO, Cato Research.

Cato Research is a privately owned, full-service CRO. The company headquarters are located in Durham, North Carolina, but the organization has other offices in the United States, as well as in Canada, Israel, and South Africa. As a CRO, Cato performs a variety of services for clients, including nonclinical, clinical, and regulatory support from the early planning stages of drug development through marketing approval. As someone without experience in drug development, I was offered a 10- to 12-month fellowship at Cato. This fellowship included both formal instruction and on-the-job training in drug development, including weekly educational seminars and discussion, assisting with project teamwork in a variety of drug development stages, writing technical documents for submission to regulatory agencies, and attending off-site courses, conferences, and meetings. In addition to training in drug development, all fellows at Cato are trained to eventually become project leaders. Project leaders are somewhat similar to academic faculty members in that they are responsible for managing personnel and tracking budgets, deliverables, and timelines.

Ideal candidates for fellow positions at Cato have strong verbal and written communication skills, leadership qualities, flexibility, time management capabilities, and are team players. To be considered for a position in the Fellows Program at Cato, one must hold a Ph.D., M.D., or master's degree.

A Day in the Life

It's 7:30 a.m., and I'm already in the office reviewing safety or adverse event data reported by investigators for patients who were treated in previously completed Phase 2 clinical trials. I'm planning for the safety summaries to be inserted into an Investigator's Brochure, a document that summarizes safety and efficacy information for an investigational study drug in clinical development and provides investigators with adequate direction for the administration and storage of study medication. By 8:30 a.m., I've enjoyed 1 hour of peace before my phone is ringing. It is a study coordinator who has a question about the procedures for an ongoing clinical trial.

Then, I'm back to reading and planning for another hour before I join a sponsor meeting at 10 a.m. In the meeting, fellow team members and I update the sponsor on the status of the project, including completed milestones and projected timelines for future deliverables (e.g., regulatory document submissions). After 1 hour of discussing the sponsor's strategy for the clinical program, I'm back at my desk responding to the e-mail messages and phone calls that have accumulated during the morning. I scan the messages, giving priority to the most urgent requests over the next hour. At noon, I head for a company-wide educational discussion on electronic New Drug Application submissions, which runs until 1:30 p.m. That's followed by a project team budget review meeting at 2 p.m., and then a dash to the airport, where I catch a 5 p.m. flight to Chicago, Illinois. Tomorrow, I will evaluate a potential new study site there for an ongoing clinical trial.

After completing the Fellows Program, I was offered a full-time position as a scientist at Cato. At the time of my promotion to scientist, I was offered the opportunity to focus on one of three drug development areas: clinical research, regulatory, or pharmaceutical development. I chose clinical research as a primary area of focus. I manage clinical trials and project teams, track timelines, budgets, and deliverables; contribute to the planning of clinical protocols and programs, including Phase 1 through Phase 3; write documents for submission to regulatory authorities; write, write, and did I mention that I write?

Life as a clinical scientist is similar to life as a basic scientist in some respects. For example, careful planning of a clinical or basic science protocol is both challenging and enjoyable. I find examining the results of a completed study even more exciting.

Although certain things about a scientific career remain consistent across various careers and positions, I have observed quite a few differences between my experience as a basic research scientist and my current position as a clinical research scientist. One difference is that the time from planning the study to finally obtaining the result is generally longer for a clinical research scientist in the drug development industry. Despite the length of time between these two stages, results learned from clinical research studies can be readily applied to human health and treatment of disease. Another difference between a basic scientist and clinical research scientist in the pharmaceutical industry, particularly in a position with a CRO, is less freedom to work in a preferred area of research or therapeutic indication. However, I see this as an opportunity to learn about new research and disease areas. Finally, my current position as a clinical research scientist at Cato in no way resembles a laboratory setting. My office is now filled with paperwork rather than pipettes and instrumentation. Although I have an occasional fond memory of performing rat surgery, I do not miss the somewhat narrow focus that I experienced performing basic research. Clearly, a defined focus is necessary for the discovery process, but I prefer to apply these discoveries in a broader clinical research setting.

I can't think of any other job that I would prefer to my current position as a clinical research scientist. What will I be doing in 5 years from now? Hopefully, more of what I am doing every day.