Previous posts by Drs. Cervinski, Parnas, and Straseski provided insight into the diversity of career options within the clinical chemistry profession highlighting an academic medical center laboratory, a large private physician organization, and a reference laboratory, respectively. I have been requested to offer a fourth perspective, that of a clinical chemist working in the industry sector. Unlike our previous posters, I do not oversee the daily operations of a clinical laboratory. I do not review QC, train residents, or provide test interpretation/consultation. Then what does a clinical chemist working in industry do exactly? To answer this, one must first understand the word “industry”. This word most commonly refers to the in vitro diagnostic (IVD), the pharmaceutical, and the biotechnology industries. Within industry the clinical chemists’ responsibilities will vary depending on the setting. In general, clinical chemists play a vital role in the research, development and/or evaluation of products (i.e. assays, devices, pharmaceuticals). For example, I work for an IVD company that designs and manufactures whole blood biosensor technologies for blood gas analyzers, bench top chemistry analyzers, and point of care devices. My primary role is to oversee studies designed to investigate the analytical and/or clinical performance of these technologies during the various stages of product development. In order to execute this function I am routinely asked to design and review protocols, analyze data using the tools of method evaluations (e.g. assessment of accuracy, precision, linearity, specificity, etc.), and present my findings both internally and externally. External presentation of the data requires the preparation of abstracts, posters, podium presentations, and publications. In addition to this research function I am called upon to provide internal training and education on a variety of topics including pathophysiology of disease, statistics, and method evaluations.
Growing up in academia and now working in industry has provided me with the opportunity to sit on both sides of the table so to speak. I now more fully appreciate the inter-dependency between industry and the clinical laboratories. Industry plays a vital role, bringing technologies and assays to market, which clinical laboratories depend on in order to deliver laboratory services. Inasmuch industry depends on the clinical laboratories to validate new assays and technologies, push the limits of existing technologies, and identify new areas of diagnostic importance. In my position, I work closely with both clinical laboratory professionals and physicians to understand their diagnostic and clinical needs, thus serving as a link between industry and the health care profession. Moreover I also represent industry in organizations such as the Clinical Laboratory Standards Institute (CLSI).
In summary, industry is an exciting setting to apply the skills and expertise of clinical chemistry in a unique way. In my role, I enjoy the large scale impact I feel my efforts have on the health care profession as a whole. I urge readers to contact me if they have further questions about this career track.
T. Scott Isbell PhD, DABCC, FACB
Director of Medical and Scientific Affairs, North America