Global Study Lead – FSP, Managed Access Program Experience

• Provide strategic leadership and overall accountability for assigned global studies and programmes from initiation through completion and archiving
• Lead and oversee Managed Access Programs across the UK and/or EMEA
• Oversee programmes involving PACT and/or PTA where applicable
• Act as a key member of the Study Leadership Team and represent Clinical Operations in strategic discussions and decision-making
• Own the operational vision and strategy for successful study delivery
• Lead global, cross-functional and matrix study teams
• Ensure delivery to agreed timelines, quality and budget expectations
• Provide oversight and support to study management colleagues handling day-to-day delivery
• Serve as the primary Clinical Operations escalation point
• Develop operational plans and conduct feasibility and upfront planning
• Identify, assess and mitigate operational risks and issues
• Communicate study/programme status, expectations, risks, issues and key decisions to stakeholders
• Provide operational input into protocols, informed consent forms and other study documentation
• Maintain programme quality, compliance and inspection readiness
• Ensure compliance with ICH-GCP, regulatory requirements, SOPs and company standards
• Provide strategic oversight of CROs, FSP providers and third-party vendors
• Support vendor assessment and selection and maintain vendor governance
• Maintain accountability for budgets and contribute to governance and financial review cycles
• Build relationships with senior stakeholders and influence decisions across matrix organisations
• Drive continuous improvement and innovative operational delivery
• Contribute therapeutic area and operational expertise across the oncology portfolio

• Significant clinical research and clinical development experience within a pharmaceutical, biotechnology or CRO environment
• Experience at Global Study Lead, Global Trial Lead, Senior Clinical Trial Manager, Senior Global Study Manager or equivalent level
• Previous experience leading or providing significant operational leadership/oversight of Managed Access Programs within the UK and/or EMEA is strongly preferred
• Extensive experience leading complex global studies or programmes and accountability for operational delivery
• Ability to lead geographically dispersed and cross-functional matrix teams
• Strong understanding of global clinical development, clinical operations and regulatory processes
• Experience managing study/programme timelines, budgets, risks and quality
• Strong CRO/vendor oversight experience, including performance or quality concern escalation
• In-depth knowledge of ICH-GCP and relevant global regulatory requirements
• Ability to operate autonomously and make complex decisions in fast-paced environments
• Strong stakeholder management and ability to influence senior stakeholders
• Excellent leadership, communication, negotiation and conflict-resolution skills
• Strong project and programme management capabilities
• Experience with PACT and/or PTA programmes
• Previous oncology studies or programmes experience advantageous
• Experience within a global pharmaceutical FSP or embedded delivery model desirable
• Experience leading complex, innovative or non-traditional clinical programme models desirable
• Experience working with investigators, external experts, regulatory authorities, CROs and third-party vendors desirable
• Bachelor's degree in Life Sciences, Health Sciences or a related scientific discipline, or equivalent relevant experience

• Fully remote work arrangement
• Standard Monday–Friday work schedule