CDO Country Cluster Head – Western Europe/Remote

Overview

In this role you will lead Ipsen’s country operations within the Clinical Development Operations framework, ensuring feasible, compliant and high-quality trial execution across a country cluster. You will steer internal teams and external FSP partners, balancing local needs with global strategy to deliver trials on time and within budget. The job focuses on site management, RBQM-driven monitoring, and inspection readiness, enabling reliable data and strong investigator relationships. This is a strategic leadership role that shapes the country portfolio and site engagement at scale.

Responsibilities

• Lead end-to-end country/cluster trial delivery ensuring timelines and recruitment targets
• Oversee FSP partners for country feasibility, site start-up, management and monitoring
• Build and mentor high-performing internal teams; ensure appropriate FSP resourcing
• Drive continuous improvement of clinical operations processes for speed, quality and compliance
• Provide governance and sponsor oversight of FSP activities at country/site level
• Establish strategic, data-driven country feasibility and site selection approaches
• Ensure RBQM and monitoring delivery (on-site, remote, centralized)
• Maintain inspection readiness and support regulatory audits/inspections
• Own site engagement strategy and identify high-potential/priority sites
• Lead change management and stakeholder collaboration across Clinical Development, QA, Regulatory and Medical

Key requirements

• Minimum 10 years in clinical trials with leadership of country operations and site management
• Experience leading teams across different sizes and operational models
• Proven track record in project/people management and cross-functional collaboration
• Strong knowledge of drug development processes, ICH-GCP, 21 CFR Part 11, major health authority regulations
• Experience in audit/inspection readiness and managing FDA/EMA inspections
• Experience with large-scale organizational change management and agile mindset
• Excellent communication across all organizational levels up to ELT
• Strong understanding of clinical systems (eTMF, CTMS, QMS) and process design
• Financial acumen and ability to manage budgets and resources
• Bachelor’s degree in a scientific field or general management; advanced degree preferred

• leadership and people development
• stakeholder management
• change management
• RBQM implementation
• Site management and monitoring
• Study start-up processes (regulatory and contractual interfaces)

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