Medical Director, Medical Affairs Dach

vor 2 Monaten


Munich, Deutschland Argenx Vollzeit

argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. 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 developed and is commercializing the first-and-only approved neonatal Fc receptor (FcRn) blocker in the U.S., Japan and Europe. The Company is evaluating efgartigimod in multiple serious autoimmune diseases and advancing several earlier stage experimental medicines within its therapeutic franchises. argenx has offices in Belgium, the United States, Japan, Switzerland, Germany, the United Kingdom, and France.

The Country Medical Affairs Director DACH will lead, continuously develop, and be accountable for the country Medical Affairs function and team, ensuring Medical Affairs represents argenx’s values as a science-driven, patient-centric organization developing innovative medicines for patients and always upholding the highest ethical standards.

Additionally the Country Medial Director will be an member of the country leadership team, champion local business needs within argenx, and serve as the primary medical representative with governmental agencies, professional associations, patient associations and the broader healthcare community.+

Key Accountabilities/Responsibilities:
The position will have the following key responsibilities:
- Lead and inspire the medical affairs field and office team, ensuring exceptional medical expertise, team empowerment and excellence in execution. Provide performance management, coaching and development opportunities- Lead development and execution of the country Medical Affairs plan, including budget control, aligned to EMEA medical affairs plan and cross-functional country plans- Build appropriate resources and capabilities to execute the Medical Affairs plan, and to fulfil Medical Affairs role in critical areas, including provision of timely medical information, pharmacovigilance reporting, and product complaints in collaboration with internal and external partners- Establish a culture of collaboration and shared goals through engagement with other functional areas at country and regional level, including Clinical Development, Commercial, Market Access,, Finance, Compliance and Legal.- Build capabilities, plans and systematic tracking of impactful medical affairs activities, including:
- Timely and informative scientific/medical exchanges with external stakeholders that accurately reflect scientific data and research objectives-
- Develop deep insights of the patient journey, treatment landscape, unmet medical needs and data gaps-
- Identify and develop productive collaborations with healthcare professionals, other important stakeholders and professional organizations-
- Gather actionable insights and disseminate throughout the organization-
- Deliver high quality scientific/medical education in all appropriate settings-
- Identify potential high-impact data generation and publication opportunities, in line with argenx identified areas of interest-
- Support argenx clinical development and operations teams to execute argenx studies-
- Manage requests for pre-approval access to argenx products-
- Ensure high quality training and ongoing education for medical affairs team, commercial staff and other functions-
- Maintain a high level of knowledge of and appropriately implement current local pharmaceutical regulation, ensure implementation of argenx policies and procedures, and enhance cross-functional understanding of compliance requirements- Contributing to the implementation and execution of the Market Access strategy, in collaboration with the Market Access team- Ensure there is an effective promotional material review & approval process, and act as final medical signatory (may be delegated) for all promotional and scientific materials- Ensure all relevant knowledge, including activities and interaction with important contacts is systematically captured and disseminated within argenx as appropriate.

Desired Skills and Experience:
- Medical, pharmaceutical or high-level scientific degree (MD, PhD)- 8+ years experience in biopharmaceutical industry- Experience leading and developing high-performing individuals and Medical Affairs teams- Experience building out Medical Affairs capabilities to meet country requirements- Experience working in complex disease areas and across therapeutic areas/products- Experience working with and influencing European/global functions and leadership- Clinical experience in neurology, immunology, and/or rare diseases is an advantage- Experience in hematology or dermatology is an advantage- Deep knowledge of relevant regulations and practices- Proven knowledge of regional market access procedures and requirements- Experience with AMNOG process and G-BA hearings are a plus- Able to identify and build busines



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