Kass Giannopoulos

Background

About Kass Giannopoulos

Experienced in leading the operational execution of global clinical trials, I specialize in managing complex Phase studies across antibacterial, antiviral, and immunology therapeutic areas. Over the course of my career, I’ve supported drug development from early clinical research through NDA submissions, contributing to pivotal trials that address critical unmet medical needs. With a strong foundation in nursing and clinical operations, I bring a holistic understanding of trial conduct—bridging scientific integrity, regulatory compliance, and operational efficiency. I’ve worked collaboratively with cross-functional teams, CROs, and regulatory bodies to ensure trial success, even under challenging conditions such as global pandemics or geopolitical disruptions. My approach is grounded in meticulous planning, proactive issue management, and clear communication—whether coordinating global site activities, overseeing vendor performance, or contributing to regulatory audits and submissions. I thrive in environments where attention to detail, adaptability, and strategic coordination make a tangible impact on advancing therapies to patients. I also believe in fostering talent and operational excellence, having mentored clinical staff and developed training programs to scale team capability and performance. Key Skills: Clinical Trial Management | Phase Studies | Antibacterial & Antiviral Research | Immunology | Regulatory Submissions | Cross-Functional Team Leadership | NDA Preparation | Vendor Oversight | Pharmacokinetics & Drug-Drug Interaction Studies | eTMF & CTMS Systems | Risk Mitigation | Budget & Scope Management | SOP Compliance | FDA & Global Health Authority Readiness | Site & CRO Management