GMA Medical Director Pipeline
vor 2 Wochen
Medical Affairs & Evidence Generation- Global Indication LeadPosition purposeThe Integrated Medical Affairs and Evidence Generation group delivers ambitious, patient-focused cross-regional and cross-indication medical strategies, driving data generation and dissemination, to maximise patient benefit from argenx products.The Global Indication Lead will provide expert medical leadership to guide development, launch planning, life cycle management and support for approved products, as relevant for the indications stage of development. Working in collaboration with cross-functional colleagues, and as a key member of the Indication Development Team the Global Indication Lead will input to development and delivery of the target product profile, clinical development plans and pre-launch strategy, and brand plans ensuring regional Medical Affairs teams insights and requirements inform all stages of development.Key Accountabilities/Responsibilities:Provide expert medical input to guide clinical development, comprehensive evidence generation, launch planning and brand plan execution in relevant indicationsDevelop and execute ambitious short-term and long-term medical strategies, as key elements of the integrated data generation plan and brand plan.Accountable for the alignment of all global medical affairs activities in partnership with other cross-functional members of the Indication Development TeamDevelop close partnerships with regional and country medical affairs leads/teams, and the regional indication strategy teams and ensure all activities maximise cross-regional impact whilst enabling regional team empowerment and supporting local deliveryBuild and maintain close partnership with external experts, in collaboration with regional/country Medical Affairs teams, to bring insight to all activities Initiate and support high impact medical activities, such as advisory boards, congress symposia and medical research projectsDrive the identification and development of productive collaborations including with healthcare organisations and experts, other important customers and stakeholders and professional organizationsSupport strategy development for investigator sponsored studies and assessment of proposalsPartner with scientific communications to support development of publication and medical education strategiesDevelop and continuously maintain the highest scientific and medical expertise with relevant diseases and products and be acknowledged internally and externally as an expertSystematically capture, distil and proactively communicate insights and activities within argenx Ensure all medical affairs activities maintain the highest standards, comply with applicable pharmaceutical regulations, as well as argenx policies and proceduresSKILLS AND COMPETENCIESAble to quickly understand complex disease areas, treatments and development and brand strategiesProven track record of building productive collaborations with external medical experts and networks and to gain actionable insightsUnderstands how to build internal cross-functional and cross-regional collaborations, ensuring broad input to decision makingEmbraces innovation and shared goalsHas excellent communication skills: verbal, written and when giving presentationsHas strong influencing skills to be able to engage effectively with internal and external stakeholdersAble to thrive as part of a team and when working independentlyProven track record of delivering results that meet or exceed targeted objectivesFluency in English, in addition to the local language(s), both oral and writtenEDUCATION, EXPERIENCE AND QUALIFICATIONSScientific, healthcare or medical degree (BSc, MS, PhD, PharmD, RN, MBBS, MB.ChB or equivalent).Substantial medical affairs experience, throughout the product lifecycleA strong understanding of the drug development process and launch planningRelevant drug development, therapeutic area expertise and existing external expert network is an advantageRobust knowledge of regulations and practices related to industry interactions with healthcare professionalsExperience partnering with regional/country and global functions and leadership
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GMA Medical Director Pipeline
vor 2 Wochen
Gümligen, Schweiz Argenx VollzeitMedical Affairs & Evidence Generation- Global Indication Lead Position purpose The Integrated Medical Affairs and Evidence Generation group delivers ambitious, patient-focused cross-regional and cross-indication medical strategies, driving data generation and dissemination, to maximise patient benefit from argenx products. The Global Indication Lead will...
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Gümligen, Schweiz Argenx Vollzeitargenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx is...
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Senior Medical Director Indication Lead
vor 1 Woche
Gümligen, Schweiz Argenx VollzeitIt is an exciting time of growth for argenx as we strive to achieve our VISION 2030. Vision 2030 includes the following goals: 50,000 patients globally on treatment with an argenx medicine, 10 labeled indications across all approved assets, including VYVGART and potentially empasiprubart, ARGX-119 and five new molecules in Phase 3 development. The Global...
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Senior Medical Director Indication Lead
Vor 2 Tagen
Gümligen, Schweiz Argenx VollzeitIt is an exciting time of growth for argenx as we strive to achieve our VISION 2030. Vision 2030 includes the following goals: 50,000 patients globally on treatment with an argenx medicine, 10 labeled indications across all approved assets, including VYVGART and potentially empasiprubart, ARGX-119 and five new molecules in Phase 3 development.The Global...
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EU Regulatory Lead Director
vor 1 Woche
Gümligen, Schweiz Argenx VollzeitFor the expansion of our regulatory team, argenx is looking for an EU Regulatory Lead Director, to support the rapid growth needed for successful commercialization. The role will report into the Head of Regulatory Affairs for Europe and New Territories. This role with cover primarily the EU and will require involvement in the other territories (e.g. UK,...
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Sr. Director Asset Regulatory Affairs Lead
vor 2 Wochen
Gümligen, Schweiz Argenx Vollzeitargenx is a global immunology company developing antibody-based medicines for patients suffering from severe autoimmune diseases. By translating immunology breakthroughs into innovative drug candidates, argenx is building a world-class portfolio of first-in-class antibodies in both early and late clinical-stages of development. Our employees are...
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Associate Director Pharmacovigilance
Vor 2 Tagen
Gümligen, Schweiz Argenx VollzeitPURPOSE OF THE FUNCTION Serve as scientific expert and pharmacovigilance resource to external and internal partners within the country/region. Assess current processes to ensure adherence to local/regional safety regulatory requirements and, where needed, enhance and/or develop new processes while assuring consistency with global standards. ROLES AND...
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Sr. Director Asset Regulatory Affairs Lead
vor 1 Woche
Gümligen, Schweiz Argenx Vollzeitargenx is a global immunology company developing antibody-based medicines for patients suffering from severe autoimmune diseases. By translating immunology breakthroughs into innovative drug candidates, argenx is building a world-class portfolio of first-in-class antibodies in both early and late clinical-stages of development. Our employees are...