Global Study Lead

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This position within GCSD (Global Clinical Study Delivery) is accountable for leading the operational strategy, planning and delivery of the study/studies end to end from CSI (Commit to Study Initiation) until study archiving to time, quality, budget, company standards and scientific requirements as outlined in the clinical development plan. The Global Study Lead (GSL) owns the vision for study success, the prioritisation of deliverables and formation of Working Groups with key leadership across the matrix organization with the Study Level Statistician and Clinical Lead.

The GSL represents Clinical Operations within the Study Leadership Team (SLT).

• Strategic study leadership & delivery: Accountable member of the Study Leadership Team (SLT) providing strategic leadership and decision‑making to deliver studies to time, quality, budget, scientific and company standards, including robust upfront feasibility, planning, governance preparation, and understanding study contribution to the broader program/submission.
• Operational oversight, risk & issue management: Provides end‑to‑end operational oversight and support to Global Study Manager and Study Manager, acting as the escalation point for Clinical Operations, vendors, and working groups; proactively identifies, assesses, and mitigates study risks while balancing risk/benefit and ensuring effective issue resolution.
• Compliance, quality & inspection readiness: Ensures compliance with ICH/GCP, applicable laws, regulations, and GSK SOPs; oversees protocol compliance, quality management, and continual inspection readiness, with strategic operational input into protocol, ICF, and key study documents.
• Stakeholder communication & matrix leadership: Accountable for translating asset requirements to the study and appropriate communication with the Clinical Operations Asset Lead and is escalation point for clinical operations, support the Working Groups leads to proactively and effectively identify, oversee, and mitigate study risks. Builds and leads empowered matrix teams, ensuring clear, timely stakeholder communication on study status, expectations, risks, and issues;
  
  provides therapeutic area expertise and contributes to ways of working and process improvement initiatives.
• Financial & vendor accountability: Accountable for study budget and financial reviews; leads assessment, selection, and holistic oversight of FSO and other study vendors in collaboration with COAL, GSM, and SM, serving as escalation point for vendor performance and delivery issues.
• Innovation, technology & efficiency: Drives innovative study delivery approaches (e.g., DCTs), acts as decision‑maker for study‑level innovation, and serves as an ambassador for AIML, automation, and digital tools to improve efficiency, quality, and ways of working across teams.

• Degree in life sciences or a related field, or equivalent experience + extensive clinical development experience and proven experience in driving operational study delivery to time, cost, and quality within the pharmaceutical industry or CRO environment.
• Proven global study leadership experience, including experience in leading global study set‑up and delivery with multi‑country execution as well as leading high‑performing, cross‑functional matrix teams and driving timely, high‑quality decision‑making in complex and high‑pressure environments.
• Strong knowledge of study management and regulatory requirements, including in‑depth understanding of ICH/GCP and global regulatory guidelines.
• Demonstrated stakeholder management and…