Elisa Dauphinée, MPH, BSN

Clinical Operations Leader with 20+ years in the biopharmaceutical industry, specializing in oncology and rare diseases with end-to-end clinical operations expertise (Phases I–IV) across global and domestic programs. Proven track record in strategic leadership, trial execution, and regulatory compliance to drive successful outcomes in complex therapeutic landscapes. Core Competencies Include: 🔹 Clinical Operations Leadership & Strategy • Extensive experience in building and leading high-performing Clinical Operations teams, developing SOPs, optimizing processes, and managing departmental budgets. • Expertise in quality frameworks to ensure regulatory compliance and operational efficiency. • Strong ability to cultivate an inclusive, high-accountability culture that fosters engagement and continuous improvement. 🔹 Strategic Resource & Vendor Management • Skilled in selecting, negotiating, and managing vendors/resources to align with study objectives, ensuring seamless execution of clinical trials. • Proven ability to optimize resource allocation in fast-paced programs. 🔹 Regulatory & Study Design Excellence • Deep expertise in protocol development, ICFs, study plans, and regulatory submissions, ensuring compliance and trial integrity. • Experience in navigating FDA, EMA, and global regulatory landscapes for rare disease and oncology assets. 🔹 Stakeholder & Cross-Functional Collaboration • Adept at building strategic partnerships with KOLs, investigators, regulatory agencies, and cross-functional teams to accelerate clinical programs. • Strong communicator, bridging gaps between clinical, regulatory, and operational teams to drive study success. 🔹 Risk Mitigation & Operational Excellence • Expertise in identifying and managing KPIs, proactively addressing risks, and driving issue resolution in complex clinical trials. • Demonstrated success in meeting critical milestones in drug development.