Clinical Operations Lead – Early Phase Overview • The Clinical Operations Lead – Early Phase oversees Phase 1 clinical development, ensuring operational excellence and compliance with regulatory standards. • Lead strategic planning, initiation, and execution of clinical trials, including vendor selection, contracts, and proactive risk management. • Collaborate globally across technical, project management, and regulatory teams to achieve organizational objectives. • Provide input on training materials, clinical development plans, and regulatory documents to ensure timely delivery of quality trials. • Drive site selection and subject recruitment programs to meet enrollment targets effectively. • Champion efficient methods and processes to enhance reliability, efficiency, cost, and quality in clinical operations. • Ensure trials are inspection-ready and comply with FDA/EMEA regulations, ICH guidelines, and GCP standards. • Contribute to the development of clinical protocols, SOPs, and study reports supporting NDA submissions. Clinical Operations Lead – Early Phase Key Responsibilities & Duties • Develop and implement clinical operations strategies and methodologies for early-phase trials. • Ensure clinical trials adhere to regulatory requirements and maintain inspection readiness. • Oversee budgets, timelines, and program implementation in compliance with local and international guidelines. • Provide operational input on training materials, standards, and clinical development plans. • Collaborate with Clinical Trial Supply Unit for comparator sourcing strategies. • Drive site selection and recruitment programs to achieve study enrollment goals. • Lead global trials with a focus on reliability, efficiency, cost, and quality metrics. • Develop clinical protocols, SOPs, and reports to support regulatory submissions. Clinical Operations Lead – Early Phase Job Requirements • Bachelor of Science (BS) in a relevant field; advanced degree preferred. • 12+ years of clinical operations experience, preferably in biotechnology or pharmaceutical settings. • Strong knowledge of FDA/EMEA regulations, ICH guidelines, and GCP standards. • Proven experience in global trial management and patient recruitment strategies. • Expertise in developing clinical protocols, SOPs, and regulatory documents. • Demonstrated ability to lead business process transformations and deliver complex projects. • Advanced skills in budget management, investigational product handling, and compliance monitoring. • Strong leadership and collaboration skills across multidisciplinary teams.