Mario E.

Background

About Mario E.

I am a Clinical Affairs leader with 10+ years of experience advancing radiotherapy, diagnostics, infectious disease, and medical device trials from concept to regulatory approval. As Director of Clinical Affairs at RefleXion Medical, I head Clinical Operations, Data Management, and Safety, driving the execution of global oncology trials and supporting IDE and 510(k) submissions. Highlights include: • Leading cross-functional teams to deliver first-in-class radiotherapy trials, IDE submissions, and 510(k) filings. • Building and scaling Clinical Operations at Inflammatix, leading first-in-human diagnostics studies and supporting multiple FDA submissions. • Managing clinical trial portfolios at JUUL Labs and Gilead Sciences, spanning ENDS regulatory filings and large global Phase 3 programs. • Teaching and mentoring the next generation of researchers as Adjunct Faculty in the SF Bay Area I thrive in high-growth environments where science and execution meet, building cross-functional alignment and inspection-ready systems that advance innovation without sacrificing compliance. My goal is to continue leading clinical programs that bring transformative therapies and devices to patients worldwide.