Clinical Drug Supply Manager

Job title:

Clinical Drug Supply Manager

Company

Basilea Pharmaceutica

Job description

We are looking for…….a highly motivated Clinical Drug Supply Manager for our Technical Operations department.Your tasks

• 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)

Your profile

• 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

About usBasilea 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).

Expected salary

Location

Allschwil, Bâle-Campagne

Job date

Sat, 26 Oct 2024 23:59:11 GMT

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