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Job title: Global Study Lead
Contract length: 6 months
Location: London or Stevenage
 

Overview

GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We are on an audacious journey to impact the health of 2.5 billion people over the next decade. Our R&D division is at the forefront of this mission, dedicated to the discovery and development of groundbreaking vaccines and medicines. We are transforming the landscape of medical research by integrating cutting-edge science and technology and harnessing the power of genetics and new data. By fostering a collaborative environment that unites the talents of our people, we are revolutionizing R&D to pre-empt and defeat diseases. Join us in our commitment to uniting science, technology, and talent to get ahead of disease together.

Role Overview

The Global Study Lead (GSL) is accountable for the end-to-end operational leadership, planning, and execution of assigned clinical study/studies from Commit to Study Initiation (CSI) through study close-out and archiving. The role ensures delivery to time, cost, quality, company standards, and scientific and regulatory requirements as outlined in the clinical development plan.

The GSL owns the vision for study success and is responsible for prioritization of deliverables, risk management, and leadership of cross-functional Working Groups in close partnership with the Clinical Lead and Study Level Statistician. The GSL represents Clinical Operations on the Study Leadership Team (SLT) and acts as the primary escalation point for operational matters.

Key Responsibilities

• Serve as a member of the Study Leadership Team (SLT) with accountability for strategic leadership and delivery of clinical study/studies to timelines, quality, budget, and scientific requirements.
• Lead and drive operational decision-making at pace, ensuring alignment with overall program and asset strategy.
• Provide oversight and support to the Global Study Manager (GSM) and Study Manager (SM) on end-to-end study delivery; act as escalation point for Clinical Operations.
• Ensure compliance with ICH/GCP guidelines, applicable laws and regulations, and company SOPs for assigned studies.
• Translate asset and program-level requirements into executable study-level operational strategies, ensuring alignment with the Clinical Operations Asset Lead.
• Proactively identify, assess, and mitigate study risks in collaboration with Working Group leads and SLT members.
• Accountable for robust study feasibility, planning, and governance readiness, including preparation of materials for governance and financial review cycles.
• Own and manage the study budget, ensuring effective cost control and financial accountability.
• Provide strategic oversight of operational input into protocol, informed consent forms, and other critical study documents.
• Oversee quality efforts to ensure protocol compliance and continuous inspection readiness.
• Lead vendor strategy, including assessment, selection, oversight, and escalation management of FSO and other clinical study vendors in collaboration with the GSM, SM, and Clinical Operations leadership.
• Implement and champion innovative approaches to study delivery (e.g., decentralized trials, digital solutions), acting as the decision-maker for study-level innovation.
• Drive continuous improvement by contributing to ways of working and process optimization initiatives.
• Act as an ambassador for increased use of AI/ML tools and automation to drive efficiencies and modernize clinical delivery.

Key Skills and Experience

• Deep understanding of global clinical trial conduct, study management, and ICH/GCP requirements.
• Strong strategic, operational, and financial acumen, including study and budget management.
• Ability to influence and engage senior stakeholders at Director, Senior Director, and VP levels.
• Proven experience managing CROs and third-party vendors, including performance recovery, negotiation, and after-action reviews.
• Strong leadership, communication, negotiation, and conflict management skills.
• Demonstrated experience leading innovative trial designs, including adaptive designs and decentralized clinical trials (DCTs); learning agility to support platform, umbrella, and basket studies.
• Ability to translate strategy into actionable plans and drive execution in complex, high-pressure environments.
• Growth mindset with the ability to work across different therapeutic areas and study types.
• Creative and forward-looking approach to modernizing clinical delivery through technology and external partnerships.
• Strong prioritization, decision-making, and problem-solving capabilities.
• Extensive experience as a strategic clinical operations leader, with accountability for global clinical studies across multiple phases, regions, and indications.
• Proven track record of delivering complex clinical trials to time, cost, and quality, either within a pharmaceutical company or CRO environment.
• Demonstrated success in leading high-performing, global, matrixed study teams with a high degree of autonomy.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

Inclusion at GSK

GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

If you need any adjustments in the recruitment process, please get in touch with our Recruitment team (EMEA-GSKLink@allegisglobalsolutions.com) to further discuss this today.

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