Medical Director

The Medical Director will provide medical leadership and support for clinical trials and safety evaluation within the Pharmacovigilance department. This includes developing clinical trial protocols with the latest 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. Responsibilities also include real-time medical monitoring of clinical studies to ensure medical validity and subject safety, proactive issue identification and resolution in consultation with the Global Medical Indication Lead, and serving as the chief liaison between sponsors and internal departments. The role involves educating investigator sites, managing day-to-day activities to resolve issues, acting as the medical point of contact for internal and external stakeholders, interacting with investigators, IRBs, and Health Authorities, and ensuring study compliance with all relevant SOPs and GCP by collaborating closely with cross-functional study team members.