Richard J. Katz, PhD
Novartis Pharmaceuticals Corporation
There is a certain clueless quality to many a graduate student's post-matriculation planning. When I graduated from Bryn Mawr College with a PhD in psychology and a comparative and physiological specialization, I had two postdoctoral opportunities: one in central nervous system (CNS) regional neurochemistry and the other in the clinical biology of depression. I went for the latter, spending 4 years at the Mental Health Research Institute at the University of Michigan working with Barney Carroll. Nothing I had experienced previously provided the heuristic immediacy and salience of close clinical observation, either for phenomenology or the biology of the therapeutic response.
My first real (i.e., postdoctoral) job was a standard academic appointment. Several factors obliged my questioning this as a personal best fit — the two most compelling being the difficulty in obtaining stable and secure extramural funding and the relative "distance" of the classroom from the clinic. I moved to Ciba-Geigy Pharmaceuticals as a clinical trials monitor to remedy both. I've been with Ciba (now Novartis due to a merger) since, but have assumed a bit more managerial responsibility over time.
Trials monitors have advanced degrees (MD, PhD, PharmD or DO) in a variety of disciplines. Typically, they have substantive grounding in their field of inquiry, with solid, broad and reasonably general critical and methodological skills. Beyond that there is rather remarkable latitude in background — my department includes two psychologists, two pharmacologists, a physical anthropologist, an osteopathic physician, and a neurologist. The job is varied, but typically embodies aspects of management and oversight. Monitors write protocols for the conduct of clinical trials, identify investigators, ensure patient safety and adherence to good clinical practices during trial conduct, examine data for trends and write clinical reports and reviews for internal and regulatory purposes. For successful drugs (a good batting average in CNS is anything over .100), monitors further integrate clinical data into rather massive requests to the Food and Drug Administration for regulatory approval. Therefore, being able to write rapidly and accurately is essential.
The responsibilities in a CNS unit are diverse. Over the years, I have worked on drugs for Alzheimer's disease, multi-infarct dementia, depression, anxiety, obsessive-compulsive disorder, posttraumatic stress disorder, social phobia, epilepsy and jet lag. In our current debates on prescribing privileges for psychologists, it should be recognized that psychologist-monitors have been instrumental in establishing the safety and efficacy of many of the drugs in question: clomipramine for obsessive- compulsive disorder (a personal success), tacrine for Alzheimer's disease, buspirone for anxiety, and nimodipine for subarachnoid hemorrhage. One of the pluses of the job is the chance to do fully funded clinical work with large (occasionally upward of 1,000) patient populations. Typically, we are looking to treat conditions for which therapies are not established or are fundamentally inadequate, so there is the opportunity to engage in innovative clinical science. Moreover, when something happens, it matters — to see patients who have been disabled for most of their adult lives improve and re-engage, even if only on paper case records, is gratifying, and when your drug is approved, you can simultaneously change medical practice and benefit millions of lives. The range of conditions on the job demands a willingness to learn a new subdiscipline every few years, and this continual learning is stimulating. Other advantages of the job include good extramural collaboration with investigators and occasional international travel. The pay and benefits are also better than for parallel academic positions.
The major negatives actually are related to the pluses. Although there is great latitude in underlying diseases treated, there must be a willingness to work on assigned projects. Thus, there is far less choice of intellectual focus. Travel can vary and can occasionally reach 50 percent of one's time. This is rare, but can be personally and physically demanding. I'm not certain whether this is a positive, a negative or a neutral, but publication is a low priority. Some of us continue to publish a paper or two per year, but there is no material consequence. Your job goes on with or without it. Papers may be held to ensure maximizing patent protections, but this probably is no longer unique to industry.
There is no single way to become a clinical trials monitor. If I were looking to prepare myself, I certainly would focus my doctoral or postdoctoral work on clinical problems, possibly doing psychiatric research. There are a large number of drug firms in the Boston-New York-Philadelphia-Wilmington corridor, and they support upward of 100 search firms that place candidates. The New York Sunday Times "Help Wanted" section has an extensive listing under "pharmaceuticals." In addition to pharmaceutical firms, head hunters are also advertised. And finally, networking should not be underestimated as a way to break into the field.
(Originally published in the July/August 1997 issue of Psychological Science Agenda, the newsletter of the APA Science Directorate.)