Director, Clinical Operations

Key details

• Provide strategic oversight and end-to-end operational leadership for global Phase 3 studies and related development activities
• Translate program strategy into comprehensive, executable operational plans aligned with regulatory, scientific, and corporate objectives
• Accountable for study timelines, budgets, resource allocation, quality metrics, and overall delivery
• Lead scenario planning, risk forecasting, and mitigation strategies at the program level
• Partner with Clinical Development leadership to inform portfolio-level planning and decision-making
• Directly manage and develop Clinical Operations staff (e.g., Clinical Study Leads and/or Clinical Trial Managers)
• Recruit, hire, onboard, and retain top talent to support late-stage clinical development
• Set performance expectations, conduct evaluations, provide coaching, and support career development
• Build a culture of accountability, collaboration, and operational excellence
• Lead multidisciplinary study teams across Clinical Operations, Data Management, Biostatistics, Safety, Regulatory, Medical, Quality, and CMC
• Act as a primary point of accountability across internal stakeholders, CRO partners, and external vendors
• Enable effective decision-making, timely escalation, and transparent communication across teams
• Oversee global study startup, site strategy, enrollment execution, monitoring approaches, and patient engagement initiatives
• Ensure compliance with ICH-GCP, global regulatory requirements, and internal SOPs
• Provide oversight of study budgets, vendor performance, and quality metrics
• Establish performance metrics and drive continuous improvement across external partnerships
• Lead inspection readiness strategy and support regulatory inspections
• Drive proactive issue identification, risk management, and CAPA oversight
• Contribute to Clinical Operations strategy, infrastructure development, and process optimization
• Champion innovation in trial execution, including digital tools, decentralized approaches, and patient-focused strategies
• Share best practices and help define standards across the clinical operations organization
• Company mission
• Information not specified