10/07/2025
🌟Member Spotlight⭐️
Michael Serrano
“Most physician assistants follow a familiar path—clinical practice, patient care, steady career progression. I took a different route, and in doing so, hope to show other PAs what’s possible beyond traditional clinical roles.
I always wanted to work with underserved populations, which led me to join the U.S. Public Health Service in 2006. I initially provided clinical care to detainees through the Department of Immigration and Health Services. When an FDA position opened up in 2008, I saw an opportunity to impact public health on an even broader scale. I was eager to learn how to inspect clinical trials and help protect patients both domestically and internationally.
Today, as a Specialist with the FDA’s Office of Bioresearch Monitoring, I conduct clinical trial and drug safety inspections around the globe. My work spans the entire pharmaceutical spectrum—from widely prescribed medications like Ozempic that benefit millions, to experimental treatments for rare diseases like ALS, to enforcement actions stopping firms from distributing drugs with serious safety concerns.
The role provides unique access to cutting-edge pharmaceutical development. I get to work with leading scientific experts, examine data across all phases of clinical trials, and contribute to decisions that directly affect patient safety and access to innovative therapies. My inspections have taken me to Taiwan, Japan, South Korea, the United Kingdom, France, and numerous other countries.
Beyond inspections, I’ve become passionate about training the next generation of investigators. I currently serve as the nationwide lead trainer for the FDA’s drug safety and Risk Evaluation and Mitigation Strategies programs, having trained over 100 federal investigators. The most rewarding aspect is seeing how they progress in their careers. This work has expanded internationally—I now lead the Good Pharmacovigilance Practices Working Group within the Pharmaceutical Inspection Co-operation Scheme, harmonizing training standards across 56 global health authorities.
My advice for PAs considering non-traditional career paths? Try it early in your career. Career transitions become more complex with increased clinical specialization, financial obligations, and family commitments. The regulatory field values our clinical training—our patient care background provides essential perspective when evaluating study protocols and safety data.
Despite my regulatory focus, I maintain active clinical practice, completing over 200 clinical hours annually since 2013. As a Public Health Service officer, I need to stay current for possible deployments. But I also value keeping up with clinical work—it ensures I retain perspective on frontline patient care, seeing and treating actual people, not just participants in a clinical trial.
The physician assistant profession possesses tremendous versatility. Our training translates effectively beyond traditional clinical settings into pharmaceutical regulation, research oversight, health policy, and other domains. For me, advocating for PA career expansion isn’t just talk—it’s a mission I live daily, proving that our profession’s possibilities extend far beyond the exam room.”
