After coping with an immediate family member’s severe illness (thankfully resolved; better living through chemistry pays off) and discovering that my talents do not lie in management within a very large company, I stepped back from my almost 20 year career in discovery research several months ago. I gleefully wallowed around the home front, decompressing from an especially stressful time in my life and just generally vegetating. But I kept my foot in the door of the Dark Tower of Pharma-dur by taking a class in drug development in a regulatory affairs program at a (sort of) local university. As it turned out, I really liked it.
When I was ready to re-enter the workforce after about 6 months, jobs for principal investigators (veteran research biochemists at any rate) in discovery pharma were very scarce. Couple that with “reductions in force” from various companies, and the job market wasn’t (and isn’t) so hot.
So, in my less-than-introspective process of thinking about “what do I want to be when I grow up,” or more accurately, “how do I wish to reinvent myself so that I can be employable,” I continued to take classes in regulatory affairs and kept an eye out for entry level jobs in the area. Wikipedia has this boilerplate description of regulatory affairs. It’s not referenced, but I can attest to its succinct accuracy. Regulatory within the pharma industry provides documentation and guidance for the highly complex process of channeling clinical findings to the Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Well, I found such a position as a medical writer in a full-service contract research organization. And I finished a not-horrible first draft of a Phase II clinical protocol today, second week into the job!
The clinical/regulatory side is a very different aspect of the Pharma-dur than discovery, but still engages my interest, even though I still get twinges for wanting to get back to the bench and design an assay or de-convolute a complex biochemical mechanism. It’s less abstract. It’s one thing to work on various defined targets for cancer: one kinase after another, maybe a methyltransferase as a novelty gag, or a metabolic enzyme that a tumor favors. It’s another to read and write a Phase I document in which patients with advanced stage carcinoma are described, knowing that they are husbands, wives, mothers, fathers, sisters, brothers and friends who are likely dying and grasping for that last gold ring of life by letting sophisticated poisons course through their blood and organs.
Thankfully, Jim has been holding down the Refuge. Not that I’m essential to this joint (and I well know there’s the pie-eyed and ever hopeful “Bring back Beck” faction), but hopefully, I can pipe up a bit more now and then now that my brain is more scientifically engaged.