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Clinical Drug Supply Manager

icon building Company : Basilea Pharmaceutica Ltd, Allschwil
icon briefcase Job Type : Full Time
icon geo-alt Allschwil

Job Description - Clinical Drug Supply Manager

....a highly motivated Clinical Drug Supply Manager for our Technical Operations department.
  • Be the primary contact for drug supply planning, inventory control, and distribution activities including label/pack scheduling, issue resolution, change implementation, vendor oversight, and scope review related to clinical supplies within the Clinical Trial and CMC Teams
  • Responsible for the strategic planning and forecasting of clinical supply needs to optimize the budget and operational aspects of the supply chain for various trials in Basilea’s clinical trial portfolio
  • Collaborate and align with the Clinical Trial and CMC teams on the master production schedule to ensure timing of clinical trial drug needs are met
  • Manage and work with third party vendors and internal stakeholders to support Requests for Proposals, production and distribution planning and demand forecasts of all drug supply needs
  • Coordinate the labeling, packaging and shipment of clinical drug supplies to depots/clinical trial sites as well as other clinical supplies activities necessary to support clinical trial objectives and timelines
  • Build and maintain collaborative relationships with third party vendors to assure the complete scope of drug supply activities remains connected with operations and compliant with quality requirements 
  • Oversee vendor operational activities including procurement of comparators and packaging materials, label development, packaging performance, on-time delivery, quality, improvement initiatives, and issue resolution
  • Establish supply chain logistics maps for each study including roles and responsibilities related to import and export of all clinical trial materials
  • Monitor and track shipments to ensure smooth transit through the logistical path including international shipping and import licenses
  • Design and prepare drug supply management training materials for investigational sites
  • Develop pharmacy manuals in collaboration with relevant cross-functional leads
  • Generate and review procedures as required and ensure compliance to relevant SOPs
  • Oversee and lead the User Acceptance Testing of Randomization and Trial Supply Management (RTSM) applications in Basilea’s Interactive Response Technology (IRT)
  • Bachelor’s Degree or equivalent in operations management, supply chain management or science related field; Certified Supply Chain Professional or APICS certification preferred. MBA desirable
  • Minimum of 5 years of relevant experience in pharmaceutical clinical supply chain management or project management, specifically in clinical supplies planning, forecasting and distribution
  • Experience in managing and working with a Contract Development and Manufacturing Organizations (CDMO) is a must
  • Excellent IT-user skills in MS-Office; Experience in RTSM applications is mandatory. Experience in the Medidata group of applications is preferred
  • Fluent in English written and spoken, German and/or any other European language is a benefit
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