Principal Manager, Clinical Operations Lead

Role: Principal Manager, Clinical Operations Lead overseeing US regional clinical trials for cancer immunotherapy programs targeting PRAME. Responsibilities: manage trial execution from start-up to completion, oversee CROs and vendors, lead cross-functional teams including Clinical Trial Managers, and ensure quality, compliance, timelines, and budgets. Drive risk management, operational excellence, and process improvements; support study initiation, site feasibility, enrollment, and operational activities; collaborate with Clinical Development, Regulatory, Safety, Biometrics, Supply Chain, and external partners; contribute to SOPs and inspection readiness; mentor junior staff. Requirements: Bachelor’s degree in life sciences or nursing; 7+ years of leadership in global clinical operations within pharma/biotech, with experience in late-phase or launch in oncology, and familiarity with cell/gene therapy or complex biologics. Preferred: Master’s degree, proven success in oncology clinical trials, operational process innovation, and cross-functional collaboration skills. High-Value: oncology, late-phase trials, biologics/cell/gene therapy modalities, remote work, US-based, supporting global clinical development.