Global Study Lead

GSK•Collegeville, PA

7d•Hybrid

About The Position

As Global Study Lead (GSL) you will lead the operational delivery of complex global clinical studies from study initiation through archiving. You will work with cross-functional and external partners to set clear study plans, manage risk, and deliver against time, quality and budget goals. We value strategic leaders who are pragmatic, collaborative, and focused on patient-centered outcomes. This role offers strong opportunities for growth, visible impact on clinical development, and the chance to contribute to GSK’s mission of uniting science, technology and talent to get ahead of disease together. This position within GCSD is accountable for leading the operational strategy, planning and delivery of the oncology study/studies end to end from CSI (Commit to Study Initiation) until study archiving as outlined in the clinical development plan. The GSL owns the vision for study success and prioritization of deliverables.

Requirements

Bachelor’s degree in life sciences, health science, nursing, pharmacy, or 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 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, regions, etc.

Nice To Haves

Advanced degree in a life sciences or related field (e.g., MSc, PharmD, PhD).
Experience with complex or adaptive trial designs, decentralized clinical trials, or platform studies.
Track record of managing large budgets and creating high-performing multi-national teams.
Experience overseeing functional service providers and CRO partnerships.
Prior experience preparing materials for governance, regulatory submissions or inspections.
Knowledge of French or additional languages relevant to Canada is an asset.

Responsibilities

Accountable for the strategic leadership and delivery of clinical study/studies to time, quality, and budget, company standards and scientific requirements, driving decision-making at pace and strategically leading study team to achieve overall study 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 compliance with ICH/GCP guidelines, all applicable laws and regulationsEnsure appropriate stakeholder communication, including study status, expectations, risks and issues and influence / manage stakeholders at senior director and/or VP level
Ensure robustness in upfront feasibility and planning
Accountable for the study budget as well as preparation of materials for governance and /or financial review cycles.
Oversee quality efforts to ensure protocol compliance and continual inspection readiness for assigned studies.
Lead assessment, selection, oversight and issue management for FSO vendors
Optimize utilization of digital and tech tools such as AIML to find efficiencies and more effective ways of working.