Operations Manager - Remote Working

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. Director, Clinical Operations – Europe Location: Europe – Remote / Hybrid 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. 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. 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. 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. 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. Monitor CRO and vendor performance through appropriate KPIs and performance metrics. Partner with Procurement, Finance, Quality and Legal functions in the negotiation and management of CRO and vendor agreements. 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. Maintain oversight of site performance throughout the study lifecycle. Partner with Medical Affairs colleagues to support appropriate investigator and KOL engagement. The Director, Clinical Operations will therefore play an important role in developing and executing the European patient recruitment strategy. Monitor recruitment and enrolment performance across European countries and sites. 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. Analyse recruitment data and site performance to prioritise resources and intervention. 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. 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. Challenge unnecessary scope changes and ensure appropriate financial control across external partners. Work closely with colleagues across Clinical Development, Medical Affairs, Regulatory Affairs, Data Management, Biostatistics, Pharmacovigilance, Quality and CMC. Provide regional operational expertise during protocol development and study planning. Partner with Regulatory colleagues around European clinical trial submissions and country-specific requirements. 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. Significant experience within Clinical Operations and clinical trial management in the biotechnology or pharmaceutical industry. Proven ability to hold CRO partners accountable for timelines, quality, budget and study performance. Detailed understanding of ICH-GCP and the European clinical trial regulatory environment. 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.