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Global Medical Director
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Job Description SummaryLOCATION: London, UK, Dublin Ireland or Barcelona, SpainROLE TYPE: Hybrid Working, #LI-HybridThe Global Medical Affairs team acts as enterprise medical voice across the asset lifecycle and leads the medical strategy for the therapeutic area. They develop/ own Integrated Evidence Plans and provide input into development while ensuring US and International medical perspectives are reflected.The Global Medical Director for Cell & Gene Therapy (C>) (Oncology) is responsible for the implementation of medical strategies globally with focus on innovative evidence solutions including interventional studies, Non Interventional Studies (NIS) and Real World Evidence (RWE) studies and implementation science projects.Job DescriptionBased on extensive experience in drug development the Global Medical Director C> (Oncology) will lead Integrated Evidence Packages in situations with higher scientific complexity and potential regulatory challenges. Will manage the most complex assets and those that potentially will require deeper pharmacovigilance expertise. Will act as a subject matter expert in the development of the overarching strategies, providing inputs during design and along the end-to-end execution of programs across different disease areas. Will provide leadership and deep medical expertise in the Therapeutic Area (TA), pivoting support based on business priorities. Will represent Global Medical Affairs (GMA) with senior stakeholders and will act as strategic partner to Biomedical Research, Development, International Medical Affairs, USMajor AccountabilitiesLead development and execution of medical affairs strategy for Oncology Cell & Gene priority programs including transformative tactics such as: research/population health, innovative partnerships and integrated evidence plansCo-develop plans for evidence generation, Medical Science Liaison (MSL) / Field Medical Affairs strategy, medical education programs, scientific publication planning and Medical Expert network development with (TAs)Co-own the development and implementation of innovative education and scientific communication plans for external stakeholdersFinancial tracking to ensure timely and cost-effective development & execution of medical activitiesPrepare Scientific Review Committee submissions for TA assets within remitPartner with Development, Strategy and growth (S&G), US and International cross-functions to shape portfolio early and diversify evidence to achieve broad access at launch and to enhance impact on clinical practice for priority programsRepresent GMA around prioritized portfolio with internal and external audiences, in collaboration with TAs including the investment, medical and regulatory communities, as well as pharmaceutical or biotechnology industry collaborators/partnersRepresent "the voice of the patient" internally and evaluate factors relevant to a patient's informed decision makingOther DutiesProvide direction and input into the development and implementation of successful reimbursement and market-access strategiesProvide proactive input to Development on potential new therapeutic indications, to enrich Registration Programs and to consider new therapeutic opportunities.Ensure that Patient Access programs are supported for all brands within the GMA and delivered with full complianceEnsures GMA activities are designed and executed in compliance with company policy guidelines and highest medical quality standardsProvide proactive medical input to asset lifecycle management to consider new therapeutic opportunitiesEnsure that Patient Access programs are supported for all brands within International Medical Affairs and delivered with full complianceRequirementsEssential:MD (Preferred) or PhD/PharmD in Health Sciences. Specialist Degree or specialist qualification related to discipline for which you will be responsible is an advantage.5+ years in Pharmaceutical Industry experience in Medical Affairs and/or Clinical DevelopmentFirm working knowledge of GCP, scientific and clinical methodology, protocol designs, management and regulatory requirements for clinical studies designated for review by regulatory authorities.Strategic mindset and able to establish credibility and influence across a range of diverse stakeholders in a matrix organization to drive change with an agile mindset & ability to lead in an agile organization across Disease AreasAbility to truly collaborate across functions and markets: serve-partner-co-createDeep understanding of health care systems and key external stakeholdersStrong track record of delivery focus for time and quality in medical affairs projects with successful development and implementation of innovative programs and processesUnderstands unmet medical needs, generates the right evidence to fulfil them, uses innovative, multichannel communication formats for effective evidence disseminationHighly preferred:Cell & Gene expertise, significant medical affairs early asset lifecycle, pre-launch and launch experience in Global organizationsExperience in developing and executing "Best in Class" processes at scaleClinical trial research experience conducted in a pharmaceutical or equivalent academic environment in TA of interest is strongly desired.Why NovartisOur purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us Learn more here:https://www.novartis.com/about/strategy/people-and-cultureYou\'ll receiveYou can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.Commitment to Diversity and InclusionNovartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.Join our Novartis NetworkIf this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/networkSkills DesiredBusiness Relationship Management (BRM), Clinical Research, Clinical Trials, Communication, Curiosity, Drug Development, Education, Job Description, Leadership, Life Science, Medical Information, Patient Care, PCB (Printed Circuit Board), Physics, Strategic Direction, Technical Training #J-18808-Ljbffr
