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Senior Manager, Clinical Supply Chain Lead

vor 2 Monaten


Marburg an der Lahn, Hessen, Deutschland CSL Behring Vollzeit
About the Role

We are seeking a highly experienced Senior Manager to lead our Clinical Supply Chain team. As a key member of our organization, you will be responsible for managing the end-to-end supply chain for assigned clinical studies, ensuring compliant, on-time delivery of study medication and ancillary materials to patients.

Key Responsibilities
  1. Supply Chain Strategy and Planning: Develop and implement multi-year clinical supply strategies and plans for assigned studies, gathering and documenting requirements for clinical supplies based on protocol attributes and clinical assumptions.
  2. Inventory Management and Distribution: Establish and monitor global networks of regional and global depots to distribute drug supplies and ancillary supplies to countries and sites in assigned clinical studies, coordinating timely and compliant importation and supply of drug supplies and ancillary supplies.
  3. Kit Design and Blinding: Determine labelling and clinical kit design based on protocol and countries' needs, implementing pooling concepts in the study.
  4. Training and Documentation: Develop clinical trial supply documents and training to support study execution for clinical sites and patients, training external stakeholders and internal global clinical study teams regarding IMP handling.
  5. IRT System Management: Utilize Interactive Response Technology (IRT) systems to ensure reliable and efficient clinical supply to depots and sites, co-developing IRT specifications for drug supply management and participating in user acceptance testing.
  6. Compliance and Quality Assurance: Ensure compliance of all clinical study activities with SOPs and regulations for assigned studies, participating in GxP audits and regulatory inspections as needed.
  7. Process Improvement and Innovation: Identify opportunities and establish business cases for process improvement and innovation projects, independently leading or participating in cross-functional process improvement and innovation projects for the clinical supply chain.
Requirements
  • University degree (BSc, MSc, PhD) in life sciences, engineering, logistics or equivalent experience.
  • Minimum of 7 years' experience in biopharmaceutical R&D or supply chain, including 4 years' experience in clinical trial supplies leading global studies.