Job title: Global Study Lead
Contract length: 9 months
Location: London or Stevnange
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 prioritisation 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 programme 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 an escalation point for Clinical Operations.
* Ensure compliance with ICH/GCP guidelines, applicable laws and regulations, and company SOPs for assigned studies.
* Translate asset and programme‑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. decentralised trials, digital solutions), acting as the decision‑maker for study‑level innovation.
* Drive continuous improvement by contributing to ways of working and process optimisation initiatives.
* Act as an ambassador for increased use of AI/ML tools and automation to drive efficiencies and modernise clinical delivery.
Key Skills and Competencies
* 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 decentralised 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 modernising clinical delivery through technology and external partnerships.
* Strong prioritisation, decision‑making, and problem‑solving capabilities.
Required Experience
* 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.
Inclusion at GSK
GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, colour, 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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