Global Study Lead

Position Summary

As a Global Study Lead, you will spearhead the operational delivery of complex global clinical studies from initiation through archiving. This pivotal role at GSK involves collaborating with cross-functional and external partners to establish clear study plans, effectively manage risks, and consistently achieve time, quality, and budget objectives. GSK values strategic, pragmatic, and collaborative leaders who are dedicated to patient-centered outcomes. This position offers significant opportunities for professional growth, high-visibility impact on clinical development, and a chance to contribute directly to GSK’s mission of uniting science, technology, and talent to overcome disease.

Responsibilities

This role within GCSD is crucial for defining and leading the operational strategy, planning, and end-to-end delivery of oncology study/studies, from Commit to Study Initiation (CSI) until study archiving, as guided by the clinical development plan. The Global Study Lead is responsible for establishing the vision for study success and prioritizing deliverables.

• Accountable for the strategic leadership and delivery of clinical study/studies on time, within budget, to quality standards, and in line with company guidelines and scientific requirements, driving rapid decision-making and strategically guiding the study team to meet overall deliverables.
• Effectively build and lead empowered, high-performing global matrix teams.
• Provide Oncology therapeutic area expertise to support operations.
• Translate strategic concepts, stakeholder feedback, and requirements into cohesive actions for the study team.
• Ensure strict compliance with ICH/GCP guidelines and all applicable laws and regulations.
• Ensure appropriate stakeholder communication, including study status, expectations, risks, and issues, influencing and managing stakeholders at senior director and/or VP level.
• Ensure robustness in upfront feasibility and planning.
• Accountable for the study budget and the preparation of materials for governance and/or financial review cycles.
• Oversee quality efforts to ensure protocol compliance and continuous inspection readiness for assigned studies.
• Lead the assessment, selection, oversight, and issue management for FSO vendors.
• Optimize the utilization of digital and tech tools such as AIML to identify efficiencies and more effective ways of working.

Why You?

This is a hybrid role based in GSK HUB locations, with an expectation to be in the office 2–3 days per week.

Basic Qualifications:

• Bachelor’s degree in life sciences, health science, nursing, pharmacy, or a related field.
• Extensive clinical development experience (5+ years) and proven experience in driving operational study delivery to time, cost, and quality within the pharmaceutical industry or CRO environment.
• Significant experience leading complex, global Oncology studies.
• Proven experience working with investigators, external experts, and oversight of Contract Research Organizations and third-party vendors.
• Strong knowledge of ICH Good Clinical Practice and global regulatory requirements.
• Proven project and budget management skills with evidence of delivering to timelines and quality targets.
• Proven depth and breadth of experience in clinical delivery, across indications, assets, phases, and regions.

Preferred Qualification:

• Postgraduate degree in a life science, clinical research, or project management field.

Key skills/competency

• Clinical Study Leadership
• Operational Delivery
• Oncology Expertise
• Project Management
• Budget Management
• ICH GCP Compliance
• Global Regulatory Requirements
• Vendor Oversight
• Matrix Team Leadership
• Risk Management