Morgan Prestwich are a boutique search firm, exclusively representing the Life Sciences industry, in particular the biotech industry, globally. A niche of ours is building teams for clinical stage biotechs around the world. We are partnered with a rare disease client, headquartered in the US looking to conduct global phase 3 trials.
Director, Clinical Operations – Europe
Rare Disease | Global Phase III Clinical Development
Location: Europe – Remote / Hybrid
Scope: European Clinical Operations within a Global Phase III Programme
The Opportunity
We are seeking an experienced Director, Clinical Operations – Europe to join an innovative rare disease biotechnology company as it enters a pivotal stage of global clinical development.
Following highly encouraging results from its Phase II clinical programme, the company is progressing its lead asset into a global Phase III programme, with clinical studies planned across Europe, North America and Asia-Pacific.
The Director, Clinical Operations – Europe will take a leading role in the planning, implementation and operational delivery of the European component of the global Phase III programme, acting as the principal Clinical Operations representative for the region.
This is a highly hands-on leadership position. The successful individual will work closely with global Clinical Development and Clinical Operations leadership while taking ownership for operational execution across Europe, including CRO oversight, vendor management, site identification and activation, patient recruitment, study timelines, budgets, quality and overall study delivery.
The role represents an opportunity to join a growing biotechnology organisation at a critical point in its development and make a significant contribution to the successful delivery of a pivotal global registration programme.
Key Responsibilities
European Clinical Operations Leadership
- Lead the operational planning and execution of the European component of global Phase III clinical trials.
- Act as the primary Clinical Operations lead for Europe, providing regional expertise and operational leadership to the global study team.
- Translate the global clinical development strategy and study protocol into an effective European operational plan.
- Take responsibility for study execution across multiple European countries, ensuring delivery against agreed timelines, budgets, quality standards and enrolment objectives.
- Identify operational risks, challenges and dependencies and develop appropriate mitigation strategies.
- Provide clear and regular updates regarding European study performance to global Clinical Operations and Development leadership.
- Ensure effective coordination between European activities and the wider global Phase III programme.
CRO & Vendor Management
- Lead the selection, onboarding, oversight and ongoing management of CROs and external clinical vendors supporting European trial activities.
- Establish clear expectations, governance structures, performance metrics and escalation processes with external partners.
- Hold CROs accountable for agreed deliverables, timelines, quality, recruitment targets and contractual commitments.
- Conduct regular operational and governance meetings with CRO partners.
- Monitor CRO and vendor performance through appropriate KPIs and performance metrics.
- Identify underperformance early and implement corrective actions and escalation plans where required.
- Review and challenge CRO operational plans, resource allocation, timelines and budgets.
- Partner with Procurement, Finance, Quality and Legal functions in the negotiation and management of CRO and vendor agreements.
- Ensure effective collaboration between external partners and internal global clinical teams.
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.