Associate Director, Medical Review (Alexion)

Built on a legacy of turning pioneering science into transformative treatments, we listen to and partner with the rare disease ecosystem to help improve outcomes for more people impacted by rare diseases across the globe.   If you want to make a real impact for patients and grow in an environment that values diversity and collaboration, join us as Associate Director, Medical Review  in Medical Monitoring Unit. The Medical Monitoring Unit is a specialized department within ARDU’s Research and Development organization dedicated to the meticulous medical review and monitoring of efficacy and safety data collected in clinical trials   o   ensure completeness, robustness, consistency, and accuracy of critical medical data to uphold the highest standards of data integrity and maintain the safety of clinical trial participants. The mission of the Medical Monitoring Unit is ensuring that the clinical data collected within the study will allow determination of the benefits and risks of the compound, as well as to allow for the intended label indication by involvement in activities related to the design, conduct, monitoring, data interpretation and reporting of individual clinical trials.     The  Associate Director, Medical Review   is an expert in technology/tools/data supporting and overseeing Senior Medical Reviewers responsible for reviewing and cleaning critical medical data collected in clinical trials and/or setting up and   maintaining   the processes/tools. This individual share accountability for the Medical Monitoring service, ensuring high-quality medical data review related to efficacy and safety at study level. The role involves active collaboration with   Medical   Monitoring Leadership Team (LT) and the Senior Scientists group on strategy and processes for   Medical   Monitoring. The Associate Director, Medical   Review   is responsible for   managing key stakeholders,   representing   Medical   Monitoring LT in technical innovation initiatives and events, and fostering technical innovation within the Medical Monitoring team. Additionally, t he Associate Director, Medical Review works closely with   the MMU LT   and Senior Medical Reviewers to ensure   optimal   utilization   of systems,   tools   and processes, supported by programming teams, in alignment with predefined plans and business needs to deliver the portfolio. They stay abreast of trends in tools, automation , AI   to   leverage   these technologies for   portfolio delivery and to improve ways of working within and beyond   Medical   Monitoring.      You will   be responsible for :   • Provide strategic assessment with an enterprise mindset and accountability for the proactive development and execution of a Medical Monitoring strategy at the study level.   • Lead the implementation of best practices, optimization, and standardization of work, processes, and tools.   • Explore technologies to propose and lead automation and improvement of Medical Monitoring processes, tools, and systems.   • Lead the execution of clinical trials; monitor, clean,   analyze , and review safety and efficacy data to   identify   trends and follow up as   appropriate .   • Support the execution of clinical trials and associated data collection activities, providing guidance to the clinical study team on-site training, oversight, patient recruitment, country and site feasibility assessments and selection, ongoing data monitoring, and study closeout.   • Support teams in preparing clinical study-related documents, including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents (may support several studies in parallel).   • Participate in investigator meeting planning and execution, including on-s