Expanded Access Manager / Post-Trial Access Specialist - FSP - UK

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Job Description At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. We are seeking an Expanded Access Manager / Post-Trial Access Specialist (Oncology) to provide operational leadership and guidance for managed access programs, including compassionate use, expanded access and post-trial access. In this role, you will build strong relationships across clinical operations, medical affairs, supply, finance, governance and other cross-functional teams, while supporting effective communication with healthcare professionals, vendors and other external stakeholders. A Day in the Life • Set up and manage operational support for post-trial managed access programs from planning through close-out, including budget coordination, clinical trial management systems, vendor communications, investigational product stock and delivery, and tracking of documents, agreements, contracts and key correspondence. • Collaborate with clinical study teams to assess feasibility, regulatory requirements, logistical plans and supply mechanisms for managed access following the close of sponsored clinical trials. • Partner with global and local medical affairs, clinical operations and cross-functional stakeholders to deliver post-trial managed access programs. • Provide day-to-day coordination to support continuity of access for post-trial patients. • Coordinate program status tracking, investigational product management, document management and data review activities in accordance with applicable regulatory requirements and Good Manufacturing Practice. • Manage vendors supporting program execution. • Coordinate expanded access activities, including document collection, filing and archiving, and tracking timelines and metrics to support timely, high-quality delivery. • Provide regular program status and utilization updates to relevant stakeholders. • Collaborate with CMC and other functional areas to support clinical supply planning and forecasting as requested by program leads. • Develop project materials and tools that enable effective operationalization and communication. • Proactively identify delivery issues and risks, coordinate corrective actions when deviations occur and communicate appropriately with stakeholders. • Track key milestones and timelines and contribute to program initiatives and process improvements. Keys to Success • Proven ability to work effectively in cross-functional teams and contribute to shared goals. • High level of integrity, accuracy and attention to detail. • Strong organizational, prioritization and project management skills, with the ability to deliver assignments on time and within budget. • Strong problem-solving skills and sound judgment in an environment where priorities may evolve. • Excellent written and verbal communication skills, with the ability to work effectively with stakeholders at different levels and across functions. • Self-motivated, resourceful and results-oriented, with the ability to work with urgency in a fast-paced environment. • Understanding of cross-functional responsibilities across areas such as Supply Chain, Regulatory, Pharmacovigilance, Legal, Medical Writing and local medical teams. Education Bachelor’s degree in a scientific or clinical discipline, or equivalent relevant education and experience. Experience • At least 3 years of relevant experience in the pharmaceutical, biotechnology, clinical research or CRO industry. • Direct experience in clinical research or managed access, for example as a study manager, Clinical Research Associate (CRA), project manager or in a comparable role. • Working knowledge of compassionate use, early access or expanded access programs. • Experience managing compassionate use, early access or post-trial access programs is preferred. • Oncology experience is preferred. • Prior clinical project management or expanded access pro

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