Global Study Lead - FSP - EMEA - Managed Access Program Experience
RemoteUnited Kingdom or Poland
Job Summary
Provide strategic leadership and operational oversight for global studies and Managed Access Programs (MAPs) from initiation through archiving. Lead cross-functional matrix teams to ensure delivery against agreed timelines, quality, and budget expectations while managing CROs and third-party vendors. Act as the primary Clinical Operations escalation point, proactively mitigating risks and driving continuous improvement across the oncology portfolio. Maintain full accountability for compliance with ICH-GCP, regulatory requirements, and inspection readiness. Serve as a key member of the Study Leadership Team, influencing strategic decisions and communication with internal and external stakeholders.
Required Qualifications
- 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
- 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
- Bachelor's degree in Life Sciences, Health Sciences or a related scientific discipline, or equivalent relevant experience
Desired Qualifications
- Previous experience leading or providing significant operational leadership/oversight of Managed Access Programs (MAPs) 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
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