For many graduate and post-graduate students in scientific fields, a career at the bench seems to be the only option. From our earliest exposures to science, we have been taught the scientific method of identifying a problem, developing a hypothesis, designing an experiment to test that hypothesis, and finally examining and interpreting our results. To many, science is synonymous with experimentation. This can range from exploratory science in academia to the development of pharmaceuticals in industry and clinical settings. What we often overlook, however, is that behind the hours and hours of experiments, there exists a bridge between the data and the rest of the world. Imran Khan of Janssen Pharmaceuticals, a division of Johnson and Johnson, and Melissa Tice of Merck sat down with students as part of the iJOBS Career Panel series to discuss the field of clinical and regulatory science, and how their career paths led them there. 
The phrase ‘clinical and regulatory science’ hardly screams excitement, though following the career panel with Drs. Khan and Tice, it was apparent that there are many different subsections of this field that allow individuals to explore and focus on exactly what interests them. In fact, the take-home messages from both panelists were the same: pursue the scientific fields that interest you most. Dr. Khan spoke about his experiences as a budding MD/PhD student at the Albert Einstein College of Medicine, where he was drawn to the fields of radiology and oncology. As he continued his residency, however, it became apparent that sitting in a dark room looking at x-ray images all day just wasn’t for him. He was torn between the allure of scientific research and being a practicing physician. With two career paths pulling him in different directions, it wasn’t until Johnson and Johnson approached him with a job opportunity in clinical medicine that he realized he could do both. As a member of the compound development team, Dr. Khan’s main role is to strategize clinical trials of new pharmaceutical compounds. This involves merging the scientific data, including pharmacological and biochemical data, with medical information to effectively plan a trial that will best demonstrate the compound’s efficacy. He liaises between scientific directors, medical directors, and regulatory committees to ensure that the trial meets all necessary requirements before being carried out. Additionally, Dr. Khan reviews both internal and external clinical trial results to determine which compounds and even which fields are worth pursuing. While this specific position may seem out of reach for an up-and-coming graduate student, Dr. Khan discussed the many other career options within clinical and pharmaceutical research that are a part of, and can lead to, his position. Medical writers, as their title implies, do a great deal of the textual development and fact-checking associated with proposing and summarizing a clinical trial. They are capable of targeting the text to a very specific audience, phrasing the data to make it easy to understand while still being impactful. Clinical scientists are in place to carry out the extensive experimentation and analysis of clinical samples. These individuals are responsible for developing and carrying out experiments, dissecting the data, and interpreting the results. Statisticians are also an integral part of the pharmaceutical development team. They must have a fine understanding of clinical and basic science to allow them to analyze the data given to them by clinical scientists. Finally, Dr. Khan mentioned that all of the clinical trials he is involved with must be reviewed by members of the regulatory affairs committee, like Dr. Tice, to ensure that they meet the necessary requirements to be carried out. While Dr. Khan focuses primarily on the internal management of clinical trials, Dr. Tice works closely with members of various international regulatory agencies worldwide, serving as an intermediary between science and marketing. Every country has its own regulatory agencies which govern the steps required before a pharmaceutical drug goes to market. In order to effectively release a product worldwide, numerous restrictions need to be addressed. It is Dr. Tice’s job to assess which of these requirements are not yet met, and plan appropriate clinical trials to meet them. Different population bases, needs of the people, availability of competitor’s drugs, and varying government regulations and quality control specifications all need to be taken into account to ensure that a drug goes to market worldwide. This means that Dr. Tice must interact daily with government agencies, doctors, marketing agencies, as well as internal quality control departments, manufacturers, and many others. It is her responsibility to first determine where there is a need for a given product, then to ensure that every minute restriction and standard for that portion of the world is met, and finally, that the product is marketed to doctors and customers in such a way that it becomes successful. To get into such an exciting and fast-paced career, Dr. Tice began where you and I are today: graduate and post-graduate education. She worked her way through graduate school, where she was turned on to protein chemistry. This led to a postdoc working on brain receptors, following her passion in Alzheimer’s research. She then explored non-laboratory scientific careers, eventually taking a position in regulatory affairs. She mentioned that she was lucky to get this position by having experience in the exact scientific field that they were looking for, despite lacking any regulatory experience. It is important to note that neither Drs. Khan nor Tice had any idea that they wanted to get involved in clinical or regulatory science when they began their scientific careers. They pursued what interested them and let their experiences determine their career path. Both panelists were able to stay active in their fields of interest while exposing themselves to new and exciting opportunities. If you find yourself struggling to stay awake at the bench doing your 8th Western blot of the week or are tired of sitting in a dark microscope room for hours on end, perhaps a career in regulatory or clinical medicine is right for you.
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