Global Study Lead - FSP - EMEA - Managed Access Program Experience
Core
Provide strategic and operational leadership for end-to-end delivery of global oncology studies and Managed Access Programs (MAPs) within the UK and EMEA.
Role type
Senior IC Global Study Lead (Clinical Operations)
Builds
Global clinical studies and Managed Access Programs for oncology portfolios
Domain
Pharmaceutical clinical operations / Oncology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global clinical development, clinical operations, ICH-GCP, regulatory processes, CRO/vendor oversight, budget management, risk mitigation, cross-functional matrix team leadership, strategic planning
Preferred skills
Managed Access Program (MAP) leadership, Post-Analysis Continuation of Treatment (PACT), Post-Trial Access (PTA), oncology therapeutic area expertise, FSP/embedded delivery model experience
Technologies
None stated
Responsibilities
Lead and oversee Managed Access Programs across UK/EMEA; Provide strategic oversight for PACT/PTA programmes; Act as key member of Study Leadership Team; Strategically lead global cross-functional matrix teams; Ensure delivery to time, quality, and budget; Provide oversight to study management colleagues; Serve as primary Clinical Operations escalation point; Develop robust operational plans; Identify and mitigate operational risks; Communicate status and risks to stakeholders; Provide oversight of protocol and documentation input; Maintain quality, compliance, and inspection readiness; Oversee CROs, FSP providers, and third-party vendors; Manage study/programme budgets; Drive continuous improvement
Seniority
Senior, hands-on IC
