Director, Global Medical Affairs, Sponsored Phase Iv Studies Milano

Director, Global Medical Affairs, Sponsored Phase Iv Studies
Milano
Lombardia, Milano

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals.

When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description:Work with country or global teams to plan and implement Phase IV GMA-sponsored clinical trials, interventional or non-interventionalThis includes all aspects of study management and oversight, including working with the CRO, engaging with non-GMA stakeholders for alignment, project management, data management, safety planning, etc. Essential Functions of the job: Create the global governance structure and implementation process for these studies. Build capabilities and infrastructure for GMA-sponsored studies; interventional and non-interventional. Build the templates, tracking and reporting process for these studies for leadership and non GMA members. Create a global Sharepoint site to house all required documents and oversee all data is added to the appropriate systems (GMA portal, ClinOps portal). Work with the responsible party (eg Country Medical Director, HEOR lead) to create the implementation and operations plan for a GMA-sponsored study. Create the governance structure and planning forum for each study. Manage and track study-specific activities and deliverables. Education Required:Master's or Doctorael level degree required. Qualifications:Master's or Doctorate level degree with 10 + years of experience in the pharmaceutical industry. 5 + years of experience in managing company-sponsored clinical trials within the pharmaceutical industry. Preferred: Experience conducting post-marketing company-sponsored trials (interventional & non-interventional). Experience managing a CRO, understanding of global regulatory requirements for company-sponsored trials. Detail-oriented, organized, excellent written & verbal communication skills. Able to function in a fast-paced environment, self-directed. Supervisory Responsibilities: YesComputer Skills: Excel, PowerPoint, Project Management Software, Smartsheet, data management databases (eg CTMS), Veeva or similar. BeiGene Global CompetenciesWhen we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters TeamworkProvides and Solicits Honest and Actionable FeedbackSelf-AwarenessActs InclusivelyDemonstrates InitiativeEntrepreneurial MindsetContinuous LearningEmbraces ChangeResults-OrientedAnalytical Thinking/Data AnalysisFinancial ExcellenceCommunicates with Clarity