Global Study Lead

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Global Study Lead

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).

In this role you will

• Strategic study leadership & delivery: Accountable member of the Study Leadership Team (SLT) providing strategic leadership and decisionmaking 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 endtoend 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 decisionmaker for studylevel innovation and serves as an ambassador for AIML automation and digital tools to improve efficiency quality and ways of working across teams.

Why you

Basic Qualifications & Skills:

We are looking for professionals with these required skills to achieve our goals:

• 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 highperforming crossfunctional matrix teams and driving timely highquality decisionmaking in complex and highpressure environments.
• Strong knowledge of study management and regulatory requirements including indepth understanding of ICH/GCP and global regulatory guidelines.
• Demonstrated stakeholder management and influence skills with the ability to engage align and influence senior leaders (Senior Director / VP level) and crossfunctional partners.
• Excellent project and budget management capabilities including proactive issue identification risk mitigation prioritization and delivery against timelines and financial targets.
• Highly developed communication leadership and collaboration skills with the ability to articulate strategy manage conflict foster psychological safety and empower others in a matrixed environment

Preferred Qualifications & Skills:

Please note the following skills are not necessary just preferred if you do not have them please still apply:

• Deep therapeutic area expertise ideally consolidated within specific indications with the agility to work across multiple therapeutic areas and study types.
• Strategic leadership experience in innovative trial designs including adaptive designs decentralised clinical trials (DCTs) and exposure to platform umbrella or basket trials.
• Extensive experience managing CROs and external vendors including oversight of performance realignment when delivery is at risk negotiation of solutions and leading AfterAction Reviews.
• Experience with complex or adaptive study designs and/or real-world evidence studies.
• Strong change leadership and growth mindset with the creativity to modernize clinical delivery leverage external technologies and networks and continuously improve ways of working.
• Proven ability to lead through influence making timely complex decisions with strong rationale championing key decisions and connecting teams to purpose.

Closing Date for Applications 13th March 2026

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Please take a copy of the Job Description as this will not be available post closure of the advert.

When applying for this role please use the cover letter of the online application or your CV to describe how you meet the competencies for this role as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

At GSK we have bold ambitions for patients aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines combining our understanding of the immune system with cutting-edge technology to transform peoples fosters a culture ambitious for patients accountable for impact and committed to doing the right thing making sure that we focus our efforts on accelerating significant assets that meet patients needs and have the highest probability of success. Were uniting science technology and talent to get ahead of disease together.

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Why GSK

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

GSK is a global biopharma company with a purpose to unite science technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade as a successful growing company where people can thrive.

We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory immunology and inflammation; oncology; HIV; and infectious diseases to impact health at scale.

People and patients around the world count on the medicines and vaccines we make so were committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients accountable for impact and doing the right thing is the foundation for how together we deliver for patients shareholders and our people.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race color religion sex (including pregnancy gender identity and sexual orientation) parental status national origin age disability genetic information (including family medical history) military service or any basis prohibited under federal state or local law.

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