(Associate) Medical Director Pulmonology, EMEA

The Medical Director will provide medical support and advice for clinical trials and safety evaluation within the Pharmacovigilance department. Responsibilities include providing medical leadership to study teams, developing clinical trial protocols with current scientific information, contributing to site selection, and reviewing/approving study protocols, amendments, Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), and protocol deviation decisions. They will also conduct real-time medical monitoring of clinical studies to ensure medical validity of endpoints and subject safety, identify medical issues early, and proactively address customer concerns in consultation with the Global Medical Indication Lead. The role involves consulting with internal groups on procedural and budgetary items, acquiring dedication from other functions to close gaps, serving as the chief liaison between sponsors and internal departments, educating investigator sites through protocol-specific presentations, and managing day-to-day activities to resolve issues and answer queries. Additionally, the Medical Director will act as the medical point of contact for internal and external stakeholders, interact with investigators as needed, answer questions from IRBs and Health Authorities, prepare and present materials to study committees, provide medical training to site staff and CRAs, and ensure medical compliance with relevant SOPs and GCP by collaborating closely with cross-functional study team members.