Medical Director - Medical Affairs EMEA

Medical Director - Medical Affairs EMEA

argenx

Remote

PURPOSE OF THE FUNCTION

The Medical Director Pipeline, Medical Affairs EMEA will provide medical leadership and expertise to all pipeline related Medical Affairs activities and to cross-functional activities, leading strategic planning and tactical execution, to further strengthen the Global Medical Affairs mission to maximize patient outcomes by setting and continuously advancing the evidence-based medical standard of care. This position will report to Head of Medical Affairs EMEA.

ROLES AND RESPONSIBILITIES

• Lead the development and implementation of the Medical Affairs strategy for pipeline assets/indications, in partnership with Global Medical Affairs, regional medical affairs pipeline colleagues, cross-functional teams and proportionate to enterprise priorities;
• Develop tactical plans and activities for new pipeline indications and products aligning with cross-functional colleagues across EMEA and global teams, including Market Access, Business Operations, and Clinical Development teams, among others;
• Contribute to the overall postmarketing strategy and evidence generation plans to ensure sufficient EMEA input and aligned overarching strategies;
• Be a key member of the cross-functional EMEA pipeline strategy team, ensuring awareness, alignment, integration, and prioritization of key tactics;
• Develop and continuously maintain the highest scientific and medical expertise across all diseases and products within the relevant therapeutic areas and be acknowledged internally and externally as an expert. Be an expert presenter, facilitator and/or discussant at advisory boards, expert meetings etc.;
• Drive the identification and development of productive collaborations with clinical experts, other important customers and stakeholders, including professional organizations;
• Initiate and support high impact medical activities, such as advisory boards, congress symposia, hospital meetings, speaker development programs and reimbursement agency education;
• Support the development and execution of publication plans, aligned with scientific communications, to ensure timely and impactful data dissemination;
• Identify and implement appropriate high-impact medical research projects to support enterprise objectives, including argenx sponsored and investigator-initiated projects;
• Coordinate the implementation of medical affairs practices, and systematic information gathering to assess new indications, the treating community, patient pathways, diagnostic practices and management strategies in relevant disease areas;
• In conjunction with clinical development, operations and global medical affairs support clinical study development, EMEA site identification/recommendations, feasibility assessment, initiation and ongoing management to achieve recruitment and study objectives;
• Coordinate the identification of patients in relevant diseases for inclusion in future clinical research projects and disease registries;
• Actively engage with all relevant cross-functional teams including science, clinical development and operations, global medical affairs, commercial strategy, and market access, providing medical leadership to development, pre-launch, launch and post-launch strategy;
• Foster an inclusive team environment for relevant new indications and products within medical affairs, including scientific communications and field-based medical teams, ensuring strategic and tactical alignment;
• Support cross-functional teams to ensure operations are patient-focused, including rapidly responding to internal and external requests and provide medical affairs support to all stakeholders;
• Attend appropriate international congresses and meetings to gather intelligence, assist personal education, ensuring these opportunities are utilized to develop relationships with important customers;
• Conduct and provide medical leadership to training programs, to field-based teams, and other functions and prepare staff to handle interactions with customers;
• Systematically capture, distil and proactively communicate insights and activities within argenx cross-functional teams;
• Ensure medical accuracy of Medical Affairs activities, including advisory boards and scientific expert meetings, studies, publications, scientific congress activities, medical education, medical information content and medical field programs;
• Ensure all medical affairs activities maintain the highest standards, comply with applicable pharmaceutical regulation, as well as argenx policies and procedures;
• As an enterprise leader, putting company mission above individual or function, with the drive and ability to role model a culture in line with our corporate values of co-creation, innovation, empowerment, excellence and humility.

SKILLS AND COMPETENCIES

• Ability to develop and maintain a high level of knowledge in complex disease areas, treatments and clinical development plans;
• Demonstrated ability to accurately and effectively evaluate medical/scientific literature and landscape to develop effective medical affairs strategies;
• Experience in developing, communicating and implementing a comprehensive medical affairs plan and pre-launch plan;
• Demonstrated ability to build productive collaborations with international medical experts;
• Relevant experience in managing evidence generation projects;
• Detailed understanding of regulations and practices, including related to industry interactions with healthcare professionals and product access;
• Ability to work collaboratively and effectively together within cross-functional teams and networks;
• Demonstrated communication skills, within a multi-cultural and multi-lingual global environment;
• Is agile and demonstrates adaptability, comfort with ambiguity, trust-building, and resilience;
• Derives energy from operating in a dynamic, complex, fast-moving, and frequently changing business environment;
• Demonstrable experience with project management, proactive planning, priority setting, and securing alignment;
• Drives toward outcomes;
• Ambitious, inquisitive naturally, a quick study, with demonstrated eagerness to continuously learn, self-improve and develop. This includes being comfortable giving and receiving feedback in a diverse environment;
• Passionate and prepared to lead and contribute to our culture, which is driven by our corporate values of co-creation, innovation, empowerment, excellence, and humility.

EDUCATION, EXPERIENCE

• Medical, pharmaceutical or high-level scientific degree (MD, PharmD preferred);
• Minimum of 10-15 years’ experience in rare diseases in Medical Affairs and clinical research and development, managing budgets and vendors;
• European or global launch experience in rare diseases is a must;
• Experience in new product planning is a must;
• Business fluency in English and at least one other major European language;
• Proven track record in leading a Medical affairs team and developing and implementing medical affairs strategies to ensure successful product development and commercialization;
• Experience in neurology and autoimmune conditions is an advantage.

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