Global Study Lead – FSP, Managed Access Program Experience

🔥 12 minutes ago

🇧🇬 Bulgaria – Remote

⏰ Full Time

🟠 Senior

👻 Ghost score 15%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 Description

• Provide strategic leadership and overall accountability for assigned global studies and programmes from initiation through completion and archiving • Lead and oversee Managed Access Programs across the UK and/or EMEA • Oversee programmes involving PACT and/or PTA where applicable • Act as a key member of the Study Leadership Team and represent Clinical Operations in strategic discussions and decision-making • Own the operational vision and strategy for successful study delivery • Lead global, cross-functional and matrix study teams • Ensure delivery to agreed timelines, quality and budget expectations • Provide oversight and support to study management colleagues handling day-to-day delivery • Serve as the primary Clinical Operations escalation point • Develop operational plans and conduct feasibility and upfront planning • Identify, assess and mitigate operational risks and issues • Communicate study/programme status, expectations, risks, issues and key decisions to stakeholders • Provide operational input into protocols, informed consent forms and other study documentation • Maintain programme quality, compliance and inspection readiness • Ensure compliance with ICH-GCP, regulatory requirements, SOPs and company standards • Provide strategic oversight of CROs, FSP providers and third-party vendors • Support vendor assessment and selection and maintain vendor governance • Maintain accountability for budgets and contribute to governance and financial review cycles • Build relationships with senior stakeholders and influence decisions across matrix organisations • Drive continuous improvement and innovative operational delivery • Contribute therapeutic area and operational expertise across the oncology portfolio

🎯 Requirements

• Significant clinical research and clinical development experience within a pharmaceutical, biotechnology or CRO environment • Experience 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 within the UK and/or EMEA is strongly preferred • Extensive experience leading complex global studies or programmes and accountability for operational delivery • Ability to lead geographically dispersed and cross-functional matrix teams • Strong understanding of global clinical development, clinical operations and regulatory processes • Experience managing study/programme timelines, budgets, risks and quality • Strong CRO/vendor oversight experience, including performance or quality concern escalation • In-depth knowledge of ICH-GCP and relevant global regulatory requirements • Ability to operate autonomously and make complex decisions in fast-paced environments • Strong stakeholder management and ability to influence senior stakeholders • Excellent leadership, communication, negotiation and conflict-resolution skills • Strong project and programme management capabilities • Experience with PACT and/or PTA programmes • Previous oncology studies or programmes experience advantageous • Experience within a global pharmaceutical FSP or embedded delivery model desirable • Experience leading complex, innovative or non-traditional clinical programme models desirable • Experience working with investigators, external experts, regulatory authorities, CROs and third-party vendors desirable • Bachelor's degree in Life Sciences, Health Sciences or a related scientific discipline, or equivalent relevant experience

🏖️ Benefits

• Fully remote work arrangement • Standard Monday–Friday work schedule

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