Medical Director - International Medical Operations

Greenwich Biosciences, Inc ,
London, Greater London
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Medical Director- International Medical Operations London / Cambridge About GW Pharmaceuticals: GW Pharmaceuticals vision is to make a positive difference in the lives of patients through the development of a portfolio of cannabinoid prescription medicines in a wide range of therapeutic indications. Our strategy is to build on our world leading position in the field of cannabinoid science and in the research, development and commercialization of cannabinoid molecules as novel prescription pharmaceutical therapeutic candidates. Epidyolex is GW's lead cannabinoid product and is a proprietary oral solution of pure plant-derived cannabidiol, or CBD. GW's Epidyolex development is initially concentrating on severe, orphan, early-onset, treatment-resistant epilepsy syndromes including Dravet syndrome, Lennox-Gastaut syndrome (LGS) and Tuberous Sclerosis Complex (TSC). We are continuing to build out our team and are looking for talented individuals dedicated to making a difference in the lives of our patients. Please go to www.gwpharm.com for additional information on our parent company. About the role: TheMedical Director- International Medical Operations is a key senior leader in GW International Medical Affairs and has an important role to ensure that the function is established as a strategic patient-centric partner with internal stakeholders and external customers. This individual will be responsible for leading and evolving the key enabling capabilities to support International Medical Affairs, currently including Medical Information, Compassionate and Early Access Supply and IIT coordination, for all territories outside of the USA where GW has country operations, either direct or via partners. In addition, the Director Medical Affairs, International Medical Operations will take responsibility as the lead nominated Medical Signatory in GW, partnering with Compliance to ensure that all Medical Signatories are effectively trained, developed and deployed across the group to meet business needs. This person will need to partner closely with the International Epilepsy and Sativex/Pipeline Medical Disease Strategy Teams, and the International Medical Affairs Country Teams, to ensure that Medical Operations is meeting their needs and is evolving to meet future opportunities at a time of significant growth in the organisation. Internally, the key working relationships beyond International Medical Affairs will be with International Marketing & Commercial, Market Access/HEOR, Legal and Compliance, US Medical Affairs, and R&D. Responsibilities: * Lead the GW International Medical Operations team (currently the International Medical Information team comprising a manager and 5 reports, and two PMs supporting CUP/EAP programmes/IITs) to optimise support for the business and external customers * Establish a high performing, customer-focused, International Medical Information team, closely aligning with US Medical Information, which includes oversight of the outsourced first line call centre * Act as the International Medical Lead for the conduct of the Early Access Programmes and Compassionate Use Supply arrangements. * Embed an IIT governance model to support the review, approval and execution of IIT requests in the International Region, in partnership with US Medical Affairs and the Global External Research Committee, and manage the IIT budget * Lead the Grants Review process for International in partnership with Compliance * Build a governance and training framework to ensure that all GW nominated Medical Signatories are appropriately onboarded and continuously educated in collaboration with Compliance * Act as the Lead Medical Signatory and represent International Medical Affairs as co-lead of the BEST (Business Ethics and Standards Team) with the Senior Director, Compliance * Continuously evaluate the changing internal and external environment and establish/develop new enabling capabilities where required to ensure that Medical Affairs brings maximal value to the business and to patients * As a key Member of the International Medical Leadership Team, ensure strong partnership with the Medical Directors for Epilepsy and Sativex/Pipeline respectively, and the Regional Medical Director responsible for the GW affiliate Medical teams, to drive International Medical strategy and decision making. * Deputise for the VP, International Medical Affairs as required * Detailed Responsibilities/Accountabilities * Drive the further development and execution of the International Medical Information strategy across the EU/Rest of World countries as appropriate, liaising closely with external vendors and country partners, and ensuring close alignment and creating synergies with US Medical Information (in the absence of a Global capability) * Oversee the approval, execution and monitoring of company agreed Early Access Programmes and manage the Compassionate Use Supply process to meet urgent unmet medical need * Partner with Compliance t

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