Description

<div><div>Overview of Job Role </div><div>The Medical Lead is a medically qualified expert responsible for providing medical oversight and input across assigned clinical development programs and during the post-marketing phase of our medicines, working in close collaboration with the pharmacovigilance team and the Clinical Development Lead (CDL). Medical responsibilities may span the entire product life cycle, but this position will have a strong focus on ensuring patient safety during the postmarketing phase of our medicines. </div><div> </div><div>Scope and responsibility </div><div><ul><li>Provision of medical input throughout the product life cycle when and where applicable, working in cross-functional clinical teams and/or project teams. </li></ul></div><div><ul><li>Lead and contribute towards postmarketing activities as medical reviewer of ICSRs, signal detection/evaluation, aggregate reports, and benefit–risk assessment. </li></ul></div><div><ul><li>Provide medical oversight and interpretation of clinical data as the medical monitor for clinical trials, including those outsourced to CRO. </li></ul></div><div><ul><li>Contribute to and review of essential documents for clinical trials. </li></ul></div><div><ul><li>Contribute to and review of scientific publications. </li></ul></div><div><ul><li>Support regulatory authority interactions where required. </li></ul></div><div><ul><li>Ensure GCP/GVP compliance. </li></ul></div><div> </div></div><div><div>Job requirements </div><div><ul><li>Only candidates with a Medical Degree (MD) will be considered. </li></ul></div><div><ul><li>At least 2 years of clinical experience in a hospital or other health care setting with direct patient contact, preferably in general medicine or internal medicine </li></ul></div><div><ul><li>At least 3 years expertise working as a safety physician with demonstrated expertise in medical review of ICSRs, signal detection/evaluation, aggregate reports, and benefit–risk assessment. </li></ul></div><div><ul><li>Demonstrated experience in a Medical Lead role required with at least 2 years of experience working directly on clinical trials, e.g. while working for a CRO or while working on sponsor-led clinical trials. </li></ul></div><div><ul><li>Demonstrated experience working in multicultural teams with strong communication skills </li></ul></div><div><ul><li>Experience working on biosimilar trials is desirable </li></ul></div><div><ul><li>Strong knowledge of GCP, global PV regulations and other relevant ICH/regulatory guidelines. </li></ul><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></div></div>

Medical Lead in Clinical & Medical Affairs

Description

Alvotech

Pipeline