Non-laboratory research careers in biotech encompass a large range of functions, including engineering, careers in medical and clinical settings, administrative/support functions and sales and marketing. Here we take a look at the medical and clinical settings positions.

When a product has been demonstrated to be safe in animals - that is, it's passed Phase 1 testing - it is ready to be tested on a small sample of humans and be submitted as a candidate for a new drug to the FDA. These activities occur in clinical settings, involve interpretation of massive amounts of clinical data and require extensive documentation to the regulatory body. Two basic paths exist: clinical research and regulatory affairs. Jobs in these functions are usually grouped together in most companies.

Clinical research

First, let's clarify the term "research" in clinical research. Clinical researchers are physicians, nurses and data management professionals who administer and interpret the reactions of patients who have been enrolled in clinical trials. Often, these patients suffer from the disease condition targeted and need to pass a set of qualification criteria set by physician specialists, who must ensure that their overall health status is sufficiently stable to participate in testing the drug candidate. Once a drug is administered to an enrolled patient, the latter is carefully monitored for reactions to the drug. These include desired effects and other "adverse" or undesired effects. Both sets of data are captured both manually and electronically. Sometimes, manual data has to be transferred to electronic form. All data eventually becomes housed in databases, where physicians and database managers interpret the overall effects of the drug on the total population of patients enrolled in the study. These activities thus constitute research in a clinical setting using clinical data.

Medical knowledge at all levels is required for careers in clinical research - physicians identify prospective patients and interpret clinical data; nurses administer drug candidates and help monitor patient reactions; even database specialists need to have some understanding of the type of data the medical professionals generate in order to collaborate with physicians in interpreting it. With the hundreds of biotech drug candidates in the pipeline, clinical research jobs are expected to continue to be plentiful.

Regulatory affairs

Regulatory affairs is the other clinically oriented track. Jobs in this function involve dealing with all aspects of the regulatory environment surrounding drug approval, including submitting New Drug Applications (NDAs), preparing submissions to the FDA summarizing clinical trial results, keeping up with legislation affecting regulatory policy, ensuring the drug company meets new regulations, and working with the marketing function to make sure the message sent to consumers is consistent with federal compliance requirements. Careers in this function often require extensive reading and writing skills, as well as enthusiasm toward activities that protect both the company and the consuming public.