Senior VP Operations needed by pharma services provider supporting biopharmaceutical companies from clinical trials to commercialisation.
Ideal candidate will have:
1. 10 years + working as a senior project/programme/general manager in a CRO within operations
2. Extensive experience of managing/delivering Clinical Trials (phases 2,3 and preferably 4)
3. 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)
4. Proven experience building capability/infrastructure around clinical trial expansion within Europe and ideally, Asia
5. Experience in managing end-to-end supply chain processes, including procurement, logistics, inventory management, and distribution
6. Experience with enterprise resource planning (ERP) systems, warehouse management systems (WMS), and other relevant technologies
7. A deep understanding of the movement of medicines across international markets and the processes/regulations by which products are transported, imported and supplied
8. Experience with clinical data management and interpretation
9. Experience in developing and managing large clinical budgets
10. Expertise in quality management systems (QMS) and Good Distribution Practices (GDP) to ensure product integrity and safety
11. Strong knowledge of FDA, EMA, and other international regulatory requirements
12. Experience in ensurin...