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Senior Manager Clinical Supply Zürich Switzerland,  


Posted on : 10 July 2017

Project Description

Main function:The Senior Manager Clinical Supply will be responsible for the oversight of clinical supply planning and management throughout the lifecycle of all clinical trials sponsored by Alvotech. 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.  Most important tasks of the job: 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 Prerequisite: The primary location for this role is Alvotech‘s office in Zurich. It is expected that Senior Manager Clinical Supply will have to travel internationally, as required by the Project or Department activities. Organization Structure: 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: Education: Bachelor degree in a science related field or Master degree in a science related field, strongly preferred. Language: Fluent in English, both written and verbal. Any additional language is advantageous. Knowledge: 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. Experience: 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 lifecycle, 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 biologicals/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). About you: 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. We offer: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. Candidates should apply to Jozefina Mijatovic (Ms.): jozefina.mijatovic@alvotech.com. Join our Alvotech team and be part of our growth! Main Function:The Head of Clinical Supply will be responsible for the oversight of clinical supply planning and management throughout the lifecycle of all clinical trials sponsored by Alvotech. This includes planning and forecasting of clinical trial material, packaging, labeling, shipment and return/destruction of clinical supplies. In addition, the Head of 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 Head of Clinical Supply is responsible for executing organizational clinical supply strategies and standards in support of clinical trials. Most important task of the job: Commit to build and maintain clinical supply processes and procedures in alignment with ICH- /GCP, GMP and GDP 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. Support vendor management processes including Request For Proposals (RFP) and Scope Of Works (SOW) with vendors. Comply with GMP, GDP and ICH /GCP, European Medicines Agency (EMA), Food and Drugs Administration (FDA) as well as any pertinent local regulations and relevant internal company procedures. Be responsible to implement and update / improve policies, Standard Operating Procedures (SOPs) and Work Instructions (WIs), as required. Prerequisite:The primary location for this role is Alvotech‘s office in Zurich. It is expected that Head of Clinical Supply will have to travel internationally, as required by the Project related of Department activities. Organisation Structure:The Head of Clinical Supply will report to and will be supervised by the VP Clinical Development, within the Clinical Development Department. Qualification and Experience: Education: Bachelor degree in a science related field or Master degree in a science related field, strongly preferred.Languages: Fluent in English, both written and verbal. Any additional language is advantageous.Knowledge: 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.Experience: 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 lifecycle, 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 biologicals/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. We offer: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. Candidates should apply to Jozefina Mijatovic (Ms.): jozefina.mijatovic@alvotech.com. Join our Alvotech team and be part of our growth!

Locations

8050 ZürichSwitzerland

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