Senior VP Operations - Patient Access - Clinical Trials

Senior VP Operations needed by pharma services provider supporting biopharmaceutical companies from clinical trials to commercialisation.

Ideal candidate will have:

• 10 years + working as a senior project/programme/general manager in a CRO within operations
• Extensive experience of managing/delivering Clinical Trials (phases 2,3 and preferably 4)
• A deep understanding of the delivery of Expanded Access Programmes (EAP's) and/or Named Patient Programmes (NPP's) and/or Compassionate Use Programmes (CUP's)
• Proven experience building capability/infrastructure around clinical trial expansion within Europe and ideally, Asia
• Experience in managing end-to-end supply chain processes, including procurement, logistics, inventory management, and distribution
• Experience with enterprise resource planning (ERP) systems, warehouse management systems (WMS), and other relevant technologies
• A deep understanding of the movement of medicines across international markets and the processes/regulations by which products are transported, imported and supplied
• Experience with clinical data management and interpretation
• Experience in developing and managing large clinical budgets
• Expertise in quality management systems (QMS) and Good Distribution Practices (GDP) to ensure product integrity and safety
• Strong knowledge of FDA, EMA, and other international regulatory requirements
• Experience in ensuring compliance with Good Clinical Practice (GCP) and other regulatory guidelines

Fantastic opportunity to join this rapidly expanding organisation in a key role offering enrolment into the Exec Team Leadership Equity plan. Hybrid working. 2 days per week in the London office. Full spec' available.