Description

<div><div>Overview of Job Role </div><div>The Clinical Supplies Specialist will be responsible for the oversight of clinical supply planning and management throughout the lifecycle of all clinical trials sponsored or indirectly supported by Alvotech. This includes, but is not limited to, planning and forecasting of clinical trial material, packaging, labelling, shipment and return/destruction of clinical supplies. </div><div>Therefore, the Clinical Supplies Specialist should be able to work independently as well as feel comfortable in being part of a multifunctional team. Therefore, both self-organisational, leadership and interpersonal skills are required for this role. </div><div>For this role, long-standing experience in all phases of clinical drug development and a thorough understanding of the overall clinical trial supply chain (ideally for biologicals/biosimilars) is required. </div><div>Scope and responsibility </div><div>Develop and maintain supply plans for biosimilar clinical studies, integrating enrolment projections, manufacturing lead times, and protocol requirements. </div><div>Conduct risk assessments to identify supply constraints and develop mitigation strategies. </div><div>Forecast comparator and reference product demand and support procurement activities. </div><div><ul><li>Plan, manage, oversee, and/or execute all clinical study supply activities including procurement of Reference Listed Drugs, ancillary items and any other requirements. </li></ul></div><div><ul><li>As part of a multifunctional team, the Clinical Supplies Specialist will be requested to collaborate with cross-functional individuals (e.g. Clinical Operations, Regulatory, Project Management) in support of project deliverables. </li></ul></div><div><ul><li>Responsible for executing organisational clinical supply strategies and standards in support of clinical trials, including cold chain management and oversight. </li></ul></div><div><ul><li>The Clinical Supplies Specialist will be responsible for the development of Investigational Medicinal Product (IMP) distribution and returns plans and will manage clinical supply documentation to maintain Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) compliance, in accordance to project scope and timelines. </li></ul></div></div><div><div>Job requirements </div><div><ul><li>Experience: 2–5 years of experience in clinical supply management, preferably within biologics or biosimilar development </li></ul></div><div><ul><li>Strong understanding of GxP requirements, cold-chain management, and biologic drug handling. </li></ul></div><div><ul><li>Experience with IRT systems and clinical trial supply forecasting tools. </li></ul></div><div><ul><li>Knowledge of biosimilar regulatory expectations is an advantage. </li></ul></div><div><ul><li>Commitment to build and maintain clinical supply processes and procedures in alignment with ICH-GMP/GCP in collaboration with CROs and clinical supply vendors. </li></ul></div><div><ul><li>Ability to drive overall clinical supply strategy and collaborate with cross-functional individuals from Clinical Operations, Clinical Science, Regulatory Affairs and Project Management. </li></ul></div><div><ul><li>Work with vendors to generate inventory reports, and review regularly budget and spending for relevant studies - Manage operating budgets for outsourced services and activities. </li></ul></div><div><ul><li>Work actively and align with Clinical Operations study managers to help create forecast for each study and program including enrolment rate and drug supply overage. </li></ul></div><div><ul><li>Design packaging and labelling requirements - Drive label creation and approvals process, including translations for all countries. </li></ul></div><div><ul><li>Support vendor management processes including Request For Proposals (RFP) and Scope Of Work (SOW) with vendors. </li></ul></div><div><ul><li>Oversee packaging and labelling activities, ensuring compliance with country-specific and study-specific regulatory requirements - Track vendor performance, KPIs, and compliance with service-level agreements. </li></ul></div><div><ul><li>Comply with ICH-GMP/GCP, European Medicines Agency (EMA), Food and Drugs Administration (FDA) as well as any pertinent local regulations and relevant internal company procedures. </li></ul></div><div><ul><li>Be responsible to implement and update / improve policies, Standard Operating Procedures (SOPs) and Work Instructions (WIs), as required </li></ul></div><div><ul><li>Maintain accurate supply documentation, audit trails, and inventory records in relevant systems (e.g., IRT, ERP, eTMF). </li></ul></div><div><ul><li>Act as subject matter expert for clinical trial supply during regulatory inspections.</li></ul></div></div><div>About the Department/Company </div><div>Alvotech is a fully integrated specialty biopharmaceutical company focused exclusively on development and manufacturing of high-quality biosimilar medicines. </div><div>Within Research and Development (R&D) function, the integrated Clinical and Medical Research (iCMR) department develops effective strategies aligned with biosimilar guidelines and health authority requirements to deliver successful clinical studies, and support post marketing-authorization related activities. </div><div>iCMR is launching an ambitious and exciting project aimed at modernizing and optimizing the departmental operating model. As part of this project, we are recruiting for the following position: </div>

Clinical Supplies Specialist in Clinical & Medical Affairs

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Alvotech

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