Clinical Drug Supply Manager

at  Basilea Pharmaceutica International

ABOUT US

Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. Basilea has about 150 employees. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial or fungal infections. We have successfully launched two hospital brands, Cresemba® for the treatment of invasive fungal infections and Zevtera® for the treatment of bacterial infections. In addition, we have preclinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN)

• 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)