Executive Director, Head of Clinical Operations Excellence

Role: Senior leadership position in Global Clinical Operations, focused on ensuring GCP compliance, process improvement, and operational excellence across clinical trial activities. Responsibilities include developing and maintaining compliance infrastructure, overseeing eTMF management, leading quality assurance initiatives, and driving continuous process enhancements through metrics and innovative methodologies. The role involves building and mentoring a high-capability team, collaborating with QA, regulatory, and development functions, and managing relationships with external vendors and inspection readiness. High-value specifics: extensive experience (≥15 years) in biotech/pharma/CRO sectors, with deep expertise in clinical trial quality systems, GCP compliance, and process optimization; strong background in clinical operations, clinical quality assurance, and regulatory requirements (ICH, FDA, EMA, PMDA); proven leadership in global, cross-functional teams; familiarity with risk-based management, CAPA, Six Sigma, LEAN, Agile; up to 25% travel. The position reports to senior leadership, involves strategic input on clinical development and sourcing, and requires advanced degrees in a scientific or healthcare discipline. Work setup is global, with responsibilities spanning multiple regions, emphasizing operational excellence, compliance, and process innovation.