Thermo Fisher Scientific
Global Study Lead - FSP - EMEA - Managed Access Program Experience
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Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
The Role
PPD is seeking an experienced Global Study Lead (GSL) to work within our Functional Service Partnership (FSP), embedded with GSK's Global Clinical Study Delivery organisation.
The Global Study Lead will provide strategic and operational leadership for the end-to-end delivery of assigned global studies and programmes, ensuring delivery to agreed timelines, quality, budget, company standards and scientific requirements.
A key focus for this opportunity will be supporting Managed Access Programs (MAPs). We are therefore particularly interested in candidates who have previous experience leading or providing significant operational oversight of Managed Access Programs within the UK and/or wider EMEA region.
Experience with Post-Analysis Continuation of Treatment (PACT) and/or Post-Trial Access (PTA) programmes would also be highly desirable.
The position will support an oncology portfolio, therefore previous oncology experience would be advantageous.
Key Responsibilities
- Provide strategic leadership and overall accountability for the operational planning and delivery of assigned studies/programmes from initiation through completion and archiving.
- Lead and oversee Managed Access Programs, ensuring effective operational delivery across the UK and/or EMEA.
- Provide leadership and oversight for programmes involving Post-Analysis Continuation of Treatment (PACT) and/or Post-Trial Access (PTA), where applicable.
- Act as a key member of the Study Leadership Team (SLT) and represent Clinical Operations in strategic study discussions and decision-making.
- Own the operational vision and strategy for successful study delivery, ensuring priorities and deliverables are clearly defined.
- Strategically lead global, cross-functional and matrix study teams to achieve programme objectives.
- Ensure studies/programmes are delivered to agreed time, quality and budget expectations.
- Provide oversight and support to study management colleagues responsible for day-to-day operational delivery.
- Serve as the primary Clinical Operations escalation point for assigned programmes.
- Develop robust operational plans and ensure appropriate feasibility and upfront planning.
- Proactively identify, assess and mitigate operational risks and issues, balancing risk and benefit when making study-level decisions.
- Ensure effective communication of study/programme status, expectations, risks, issues and key decisions to internal and external stakeholders.
- Provide strategic oversight of operational input into protocols, informed consent forms and other key study/programme documentation.
- Maintain oversight of programme quality, compliance and inspection readiness.
- Ensure compliance with applicable ICH-GCP requirements, regulatory requirements, SOPs and company standards.
- Provide strategic oversight of CROs, FSP providers and third-party vendors, acting as an escalation point when performance or deliverables are at risk.
- Support vendor assessment and selection and ensure appropriate ongoing vendor governance and oversight.
- Maintain accountability for study/programme budgets and contribute to governance and financial review cycles.
- Build effective relationships with senior stakeholders and influence decision-making across complex matrix organisations.
- Drive continuous improvement and identify innovative approaches to operational delivery.
- Contribute therapeutic area and operational expertise to support successful delivery across the oncology portfolio.
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Required Experience
- Significant clinical research and clinical development experience within a pharmaceutical, biotechnology or CRO environment.
- Proven experience operating at Global Study Lead, Global Trial Lead, Senior Clinical Trial Manager, Senior Global Study Manager or equivalent level.
- Previous experience leading or providing significant operational leadership/oversight of Managed Access Programs (MAPs) within the UK and/or EMEA is strongly preferred for this position.
- Extensive experience leading complex global studies or programmes and taking accountability for operational delivery.
- Proven ability to lead high-performing, geographically dispersed and cross-functional matrix teams.
- Strong understanding of global clinical development, clinical operations and regulatory processes.
- Demonstrated experience managing study/programme timelines, budgets, risks and quality.
- Strong CRO/vendor oversight experience, including management and escalation of performance or quality concerns.
- In-depth knowledge of ICH-GCP and relevant global regulatory requirements.
- Demonstrated ability to operate autonomously and make complex decisions in fast-paced environments.
- Strong stakeholder management skills with the ability to influence senior stakeholders.
- Excellent leadership, communication, negotiation and conflict-resolution skills.
- Strong project and programme management capabilities.
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Highly Desirable Experience
- Managed Access Program (MAP) leadership experience within the UK and/or EMEA.
- Experience with Post-Analysis Continuation of Treatment (PACT).
- Experience with Post-Trial Access (PTA) programmes.
- Previous experience supporting oncology studies or programmes.
- Experience working within a global pharmaceutical FSP or embedded delivery model.
- Experience leading complex, innovative or non-traditional clinical programme models.
- Experience working with investigators, external experts, regulatory authorities, CROs and third-party vendors.
Education
- Bachelor's degree in Life Sciences, Health Sciences or a related scientific discipline, or equivalent relevant experience.
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