Director Clinical Operations - EU

Site Identification, Start-Up & Management

• Lead European country and site feasibility, selection and activation strategy.
• Work closely with Medical Affairs, Clinical Development, CRO partners and regional experts to identify appropriate investigators and centres of excellence.
• Evaluate sites based on patient populations, investigator experience, competing studies, recruitment capability and operational performance.
• Oversee site start-up activities and proactively identify barriers that could impact activation timelines.
• Maintain oversight of site performance throughout the study lifecycle.
• Build productive relationships with key investigators and clinical research centres across Europe.
• Partner with Medical Affairs colleagues to support appropriate investigator and KOL engagement.

Patient Recruitment & Trial Delivery

• Rare disease clinical trials present unique operational challenges, particularly around patient identification, small and geographically dispersed patient populations and competition for specialist clinical sites.
• The Director, Clinical Operations will therefore play an important role in developing and executing the European patient recruitment strategy.
• Responsibilities will include:
  • Monitor recruitment and enrolment performance across European countries and sites.
  • Identify recruitment challenges early and implement appropriate mitigation strategies.
  • Work with CROs, investigators, Medical Affairs and patient engagement colleagues to understand regional patient pathways.
  • Evaluate referral networks and opportunities to improve patient identification and site-to-site referrals.
  • Support appropriate patient recruitment and retention initiatives.
  • Analyse recruitment data and site performance to prioritise resources and intervention.
  • Ensure European recruitment activities remain aligned with global enrolment objectives.

Study Management & Operational Excellence

• Maintain oversight of European study milestones from start-up through enrolment, treatment, database lock and study close-out.
• Ensure appropriate monitoring strategies and oversight mechanisms are established.
• Review study metrics and operational dashboards to identify emerging risks.
• Lead resolution of significant operational issues affecting European study execution.
• Support inspection readiness and ensure appropriate documentation and oversight throughout the study.
• Maintain effective oversight of TMF quality and completeness in partnership with CRO and internal stakeholders.
• Ensure studies are conducted in accordance with ICH-GCP, applicable EU regulations, local requirements, company SOPs and study protocols.
• Contribute to the continued development of Clinical Operations processes and infrastructure as the organisation grows.

Budget & Resource Management

• Develop and maintain oversight of European clinical trial budgets and forecasts.
• Review CRO and vendor proposals, change orders and invoices.
• Challenge unnecessary scope changes and ensure appropriate financial control across external partners.
• Track expenditure against study budgets and provide accurate forecasts to senior leadership.
• Evaluate regional resource requirements and recommend additional internal or external resources where appropriate.

Cross-Functional & Global Collaboration

• Work closely with colleagues across Clinical Development, Medical Affairs, Regulatory Affairs, Data Management, Biostatistics, Pharmacovigilance, Quality and CMC.
• Represent European Clinical Operations within global study team meetings.
• Provide regional operational expertise during protocol development and study planning.
• Identify European-specific considerations that could impact protocol feasibility or operational execution.
• Partner with Regulatory colleagues around European clinical trial submissions and country-specific requirements.
• Establish strong working relationships with global colleagues across the US, Europe and APAC.
• Ensure effective communication between global leadership, CRO partners and European study teams.

Candidate Profile

The successful candidate will be an experienced Clinical Operations professional with a strong track record of delivering international Phase II and/or Phase III clinical trials within biotechnology or pharmaceutical organisations.

Essential Requirements

• Significant experience within Clinical Operations and clinical trial management in the biotechnology or pharmaceutical industry.
• Previous experience at Associate Director, Director or equivalent level, or a highly experienced Clinical Trial Lead ready to take broader regional responsibility.
• Demonstrable experience leading Phase III clinical trials.
• Strong experience managing clinical studies across multiple European countries.
• Extensive experience of CRO oversight and vendor management.
• Proven ability to hold CRO partners accountable for timelines, quality, budget and study performance.
• Strong experience with site feasibility, site selection, study start-up, enrolment and ongoing site management.
• Experience managing complex clinical trial budgets and vendor contracts.
• Detailed understanding of ICH-GCP and the European clinical trial regulatory environment.
• Experience working within global, cross-functional study teams.
• Strong project management, organisational and problem-solving capabilities.
• Excellent written and verbal English.
• Based within Europe with the ability to travel to clinical sites, investigator meetings and company meetings as required.