Senior Director, US Head Country Operations Management, Study Start-up & Site Partnership
Core
Lead the US operating model and end-to-end delivery of clinical studies from planning through close-out, managing a team of 65+ employees.
Role type
Senior Director, Clinical Operations
Builds
Clinical studies and country operations infrastructure
Domain
Biotechnology / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical trial lifecycle management, team leadership (65+), US regulatory compliance (ICH/GCP), strategic planning, risk management, budget management, stakeholder influence, operational transformation, AI/analytics integration, workforce strategy
Preferred skills
Experience in rare disease landscape, advanced analytics implementation, cross-functional partnership
Technologies
AI, advanced analytics, eTMF
Responsibilities
Own and govern the US Country Operations model; Lead a Country Operations team of 65+ employees; Direct end-to-end study delivery; Drive US enrollment and clinical trial diversity targets; Serve as the primary decision-maker and escalation point for US operations; Lead Study Start-up excellence; Oversee the US institutional and site alliance strategy; Develop innovative site solutions and preferred vendor strategies; Ensure compliance with SOPs, ICH/GCP, and US regulations; Partner across multiple functions to align execution; Maintain expertise in US policies and regulations; Use global metrics and KPIs to monitor study performance; Embed AI and advanced analytics across feasibility modeling and enrollment forecasting; Develop and execute a national workforce strategy; Build, coach, and retain a high-performing leadership team; Optimize resources across development phases; Develop and manage country budgets; Lead transformation across country infrastructure; Deliver credible, data-informed feasibility plans; Strengthen communication between US and global study leadership; Ensure a country-level post-trial access plan is established.
Seniority
Senior Director, strategic and operational leadership
