Senior Manager Clinical Supply - Switzerland
- The Senior Manager Clinical Supply will be responsible for the oversight of clinical supply planning and management throughout the life cycle of all clinical trials sponsored by our company.
- This includes planning and forecasting of clinical trial material, packaging, labeling, shipment and return/destruction of clinical supplies. In addition, the Senior Manager Clinical Supply will be responsible to develop Investigational Medicinal Product (IMP) distribution and returns drug plans and manages clinical supplies documentation to maintain Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and Good Clinical Practice (GCP) compliance, in accordance to project scope and timelines.
- Furthermore, the Senior Manager Clinical Supply is responsible for executing organizational clinical supply strategies and standards in support of clinical trials.
- Commit to build and maintain clinical supply processes and procedures in alignment with ICH- /GCP, GMP and GDP
- Implement, lead, coordinate and maintain an Interactive Response Technology (IRT)
- Act as subject matter expert for clinical trial supply during regulatory inspections
- Drive overall clinical supply strategy and collaborate with cross-functional individuals from Clinical Operations, Clinical Development, Regulatory and Project Management
- Work actively and align with Clinical Operations to help create forecast for each study and program including enrollment rate
- Design packaging and labeling requirements and manage operating budgets for sourced services and activities
- The Senior Manager Clinical Supply will report to and will be supervised by the VP Clinical Development, within the Clinical Development Department.
Qualification and Experience:
- Proficient in use of a PC and common Microsoft packages such as Word, Visio, Excel, PowerPoint in addition to technical software required for the specific function. Extensive knowledge and understanding of GMP/ GDP and GCP and other relevant ICH/regulatory guidelines, as mandatory to participate in internal and external audits as well as regulatory inspections.
- 3 - 5+ years in relevant functions in the Pharmaceutical Industry, or equivalent.
- Demonstrated experience in leading and implementation of IRT and supply distribution operations and Clinical Trial Material life-cycle, and a long-standing experience in all phases of clinical drug development and a thorough understanding of the overall clinical trial supply chain, especially for biological/biosimilars is essential.
- Proven Leadership skills and demonstrated ability to interact collaboratively in a cross-functional environment is required as well with Contract Manufacturing Organization (CMO) / Contract Research Organization (CRO).
This role requires to lead, participate and make positive contribution to team meetings by being an active and open communicator, share knowledge and experience with other team members, combined with a tolerant, considerate and team-work attitude. Your daily behavior and actions should be driven by the company’s values.
To be part of a growing team dedicated to improving access-to-medicine, we offer opportunities to bring forward ideas, lead change and ongoing opportunities for personal development and growth in an international company.