I am a clinical research professional with over 20 years of experience designing and directing global drug studies. My background includes leading Phase 1 through Phase 3b studies, PK studies, and bioequivalence studies with clinical endpoints, for both proprietary and generic pharmaceutical companies.
I worked my way through the ranks from study monitor, clinical project manager, principal scientist, director of clinical development, to senior director of clinical operations. In these various roles, I gained a reputation for creating and promoting innovative cost-effective solutions to difficult clinical study problems.
Medical writing has been a unifying theme throughout my career. I’ve authored and edited scores of clinical study documents, and then implemented them during study conduct—put the rubber to the road, so to speak. This experience has given me a unique perspective on what needs to be, what should be, and—perhaps most importantly—what should not be included in clinical study documents.
In 2016, I started Clinical Directions, LLC, to provide medical writing and clinical development expertise to pharmaceutical and biotech companies, clinical research organizations, and specialty vendors. I especially enjoy working with small and emerging biotech companies and niche CROs, where I bring extra value to my clients with my broad background in clinical operations.
When I’m not at my stand-up desk working on your projects, you may find me camping and hiking in the desert southwest, backcountry skiing in the Rocky Mountains, or bicycle touring in Europe. As a not-very-skilled novice mountain biker, my main goal is to stay upright and on-trail while avoiding rocks, trees, snakes, and broken bones; I have been somewhat successful in that endeavor!
Let’s get in touch to discuss how I may help you with your medical writing or clinical development projects.