Global Study Lead - FSP - EMEA - Managed Access Program Experience

h3Work Schedule /h3 pStandard (Mon-Fri) /p h3Environmental Conditions /h3 pOffice /p h3Job Description /h3 h3The Role /h3 pPPD is seeking an experienced bGlobal Study Lead (GSL) /b to work within our Functional Service Partnership (FSP), embedded with GSK's Global Clinical Study Delivery organisation. /p pThe 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 btimelines, quality, budget, company standards and scientific requirements /b . /p pA key focus for this opportunity will be supporting bManaged Access Programs (MAPs) /b . We are therefore particularly interested in candidates who have previous experience leading or providing significant operational oversight of bManaged Access Programs within the UK and/or wider EMEA region /b . /p pExperience with bPost-Analysis Continuation of Treatment (PACT) /b and/or bPost-Trial Access (PTA) /b programmes would also be highly desirable. /p pThe position will support an boncology portfolio /b , therefore previous oncology experience would be advantageous. /p h3Key Responsibilities /h3 ul lipProvide strategic leadership and overall accountability for the operational planning and delivery of assigned studies/programmes from initiation through completion and archiving. /p /li lipLead and oversee bManaged Access Programs /b , ensuring effective operational delivery across the UK and/or EMEA. /p /li lipProvide leadership and oversight for programmes involving bPost-Analysis Continuation of Treatment (PACT) /b and/or bPost-Trial Access (PTA) /b , where applicable. /p /li lipAct as a key member of the bStudy Leadership Team (SLT) /b and represent Clinical Operations in strategic study discussions and decision-making. /p /li lipOwn the operational vision and strategy for successful study delivery, ensuring priorities and deliverables are clearly defined. /p /li lipStrategically lead global, cross-functional and matrix study teams to achieve programme objectives. /p /li lipEnsure studies/programmes are delivered to agreed btime, quality and budget /b expectations. /p /li lipProvide oversight and support to study management colleagues responsible for day-to-day operational delivery. /p /li lipServe as the primary Clinical Operations escalation point for assigned programmes. /p /li lipDevelop robust operational plans and ensure appropriate feasibility and upfront planning. /p /li lipProactively identify, assess and mitigate operational risks and issues, balancing risk and benefit when making study-level decisions. /p /li lipEnsure effective communication of study/programme status, expectations, risks, issues and key decisions to internal and external stakeholders. /p /li lipProvide strategic oversight of operational input into protocols, informed consent forms and other key study/programme documentation. /p /li lipMaintain oversight of programme quality, compliance and inspection readiness. /p /li lipEnsure compliance with applicable bICH-GCP requirements, regulatory requirements, SOPs and company standards /b . /p /li lipProvide strategic oversight of CROs, FSP providers and third-party vendors, acting as an escalation point when performance or deliverables are at risk. /p /li lipSupport vendor assessment and selection and ensure appropriate ongoing vendor governance and oversight. /p /li lipMaintain accountability for study/programme budgets and contribute to governance and financial review cycles. /p /li lipBuild effective relationships with senior stakeholders and influence decision-making across complex matrix organisations. /p /li lipDrive continuous improvement and identify innovative approaches to operational delivery. /p /li lipContribute therapeutic area and operational expertise to support successful delivery across the oncology portfolio. /p /li /ul h3Required Experience /h3 ul lipSignificant clinical research and clinical development experience within a bpharmaceutical, biotechnology or CRO environment /b . /p /li lipProven experience operating at bGlobal Study Lead, Global Trial Lead, Senior Clinical Trial Manager, Senior Global Study Manager or equivalent level /b . /p /li lipbPrevious 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. /b /p /li lipExtensive experience leading complex global studies or programmes and taking accountability for operational delivery. /p /li lipProven ability to lead high-performing, geographically dispersed and cross-functional matrix teams. /p /li lipStrong understanding of global clinical development, clinical operations and regulatory processes. /p /li lipDemonstrated experience managing study/programme timelines, budgets, risks and quality. /p /li lipStrong CRO/vendor oversight experience, including management and escalation of performance or quality concerns. /p /li lipIn-depth knowledge of bICH-GCP and relevant global regulatory requirements /b . /p /li lipDemonstrated ability to operate autonomously and make complex decisions in fast-paced environments. /p /li lipStrong stakeholder management skills with the ability to influence senior stakeholders. /p /li lipExcellent leadership, communication, negotiation and conflict-resolution skills. /p /li lipStrong project and programme management capabilities. /p /li /ul h3Highly Desirable Experience /h3 ul lipbManaged Access Program (MAP) leadership experience within the UK and/or EMEA. /b /p /li lipExperience with bPost-Analysis Continuation of Treatment (PACT) /b . /p /li lipExperience with bPost-Trial Access (PTA) /b programmes. /p /li lipPrevious experience supporting boncology studies or programmes /b . /p /li lipExperience working within a global pharmaceutical FSP or embedded delivery model. /p /li lipExperience leading complex, innovative or non-traditional clinical programme models. /p /li lipExperience working with investigators, external experts, regulatory authorities, CROs and third-party vendors. /p /li /ul h3Education /h3 pBachelor's degree in bLife Sciences, Health Sciences or a related scientific discipline /b , or equivalent relevant experience. /p pThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. /p #J-18808-Ljbffr