Medical Affairs and Evidence Generation Asset Lead –Executive Director

Medical Affairs and Evidence Generation Asset Lead –Executive Director

The Medical Affairs and Evidence Generation (MA&EG) Asset Lead provides expert medical insights to inform indication selection, target product profile development, clinical development plans, and pre-launch and commercialization strategies working with global cross-functional team members from science, clinical development, medical affairs and evidence generation, and commercial. This strategic leader serves in a “player coach” capacity with responsibilities for the Integrated Evidence Generation Plans and other relevant MA&EG activities working with the broader MA&EG community members who support the asset. Additionally, as the molecule moves through its lifecycle this individual will also serve as a people manager with responsibilities for hiring, coaching, and developing MA&EG indication leads for the asset.

This individual will sit on the argenx Asset Strategy Team for the molecule and other related cross-functional teams to represent the totality of the MA&EG activities, insights, and deliverables and provide overall strategic insights that will enable maximal patient benefit for the medicine. Additionally, this individual is a member of the argenx MA&EG Leadership Team and is responsible for contributing to the evolution of MA&EG at argenx, helping to build a best-in-industry organization.

Specifically, this position is the MA&EG Strategy Lead for ARGX-121, a novel anti-IgA monoclonal antibody engineered to selectively remove pathogenic IgA from circulation and inhibit IgA-mediated inflammatory signaling. By combining FcRn-mediated IgA sweeping with blockade of the IgA receptor FcαRI (CD89), ARGX-121 is designed to address the root cause of IgA-driven disease. The lead indication is IgA nephropathy (IgAN), with future expansion opportunities being explored across additional IgA-mediated disorders.

Reporting Line

Reports into the Global Head, Medical Affairs & Evidence Generation

Roles and Responsibilities

Serve as the MA&EG lead on the ARGX-121 Asset Strategy Team to provide strategic guidance based on deep insights, with input from regional and country MA&EG teams (US, DE, JP, Developed Markets, Emerging and Partner Markets), to guide development and life cycle management of the argenx clinical asset, including the identification of new indications based on biology and mechanism of the disease that maximize patient outcomes and accessWork closely with ARGX-121 Science, Clinical Development, MA&EG, and Commercial teams to execute all related lifecycle deliverables from development through commercialization including but not limited to providing input into development clinical trial protocols, study site selection, partnering with the clinical study team to troubleshoot study issuesDevelop and execute ambitious Integrated Evidence Generation Plans throughout the product lifecycleLead the ARGX-121 MA&EG argenx Community and partner with colleagues to develop and execute medical strategies via scientific communications/publications, advisory boards, medical information, congress activities, medical field content development, and data generation activities; communicate with the Community regularly about the asset’s development strategy and plansAs the molecule progresses in its development, hire and manage indication leadsCo-create and help drive MA&EG strategies as a member of the MA&EG Leadership Team that align with and help accelerate achievement of argenx Vision 2030 and beyond with the expansion of our investment across indications, molecules, and patient impact Foster an inclusive and collaborative team environment that supports innovative solutions and strategies, works flexibly, and empowers people to do their best workEnsure all medical affairs activities maintain the highest standards, comply with applicable pharmaceutical regulation, as well as argenx policies and procedures

SKILLS AND COMPETENCIES

Ability to develop and maintain a high level of knowledge in complex disease areas, treatments and clinical development plansDemonstrated ability to accurately and effectively evaluate/interpret medical/scientific literature and the evolving treatment landscape to develop effective medical affairs strategies to achieve indication/molecule goals with a proven track record of delivering results that meet or exceed targeted objectivesExcellent communication (written and oral) and interpersonal skills with the ability to engage with and influence a diverse group of stakeholders. Experience preparing, adapting and delivering presentations and complex dataAbility to work in a complex, fast-moving, and matrixed environment and lead teams through ambiguity. Demonstrates agility and ability to manage competing demands and prioritize. Able to balance short-te