Medical Affairs and Evidence Generation Asset Lead – Executive Director

This position is the MA&EG Strategy Lead for FB-102, a first-in-class anti-CD122 monoclonal antibody designed to selectively modulate pathogenic T-cell and NK-cell activity that drives autoimmune disease, with current development efforts ongoing in celiac disease, vitiligo, and alopecia areata.

Roles and Responsibilities

• Serve as the MA&EG lead on the FB-102 Asset Strategy Team to provide strategic guidance based on deep insights, with input from regional and country MA&EG teams, 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 access
• Work closely with FB-102 Science, Clinical Development, MA&EG, and Commercial teams to execute all related lifecycle deliverables from development through commercialization including providing input into development clinical trial protocols, study site selection, partnering with the clinical study team to troubleshoot study issues
• Develop and execute ambitious Integrated Evidence Generation Plans throughout the product lifecycle
• Lead the FB-102 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
• As the molecule progresses in its development, hire and manage indication leads
• Co-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
• Foster an inclusive and collaborative team environment that supports innovative solutions and strategies, works flexibly, and empowers people to do their best work
• Ensure 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 plans
• Demonstrated ability to accurately and effectively evaluate/interpret medical/scientific literature and the evolving treatment landscape to develop effective medical affairs strategies
• Excellent 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 data
• Ability 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
• Understands the value of co-creation and collaboration across functions with an ability to seek input from multiple stakeholders and across multiple geographies
• Able to coach and develop people and values the empowerment of others
• Strong problem-solving skills with a proactive, solution-oriented mindset
• Detailed understanding of regulations and practices, including related to industry interactions with healthcare professionals and product access

Education, Experience and Qualifications

• Advanced degree in a scientific specialty (MD, PhD, PharmD or equivalent) required
• 15 years of gastroenterology clinical practice experience, gastroenterology research experience, and/or specific gastroenterology biopharmaceutical industry experience
• Min 5 years medical affairs industry strongly preferred
• Experience designing, conducting, and interpreting clinical trials
• Knowledge of drug development and an existing expert network is an advantage
• Strong team player who has proven interpersonal skills to work in a fast-paced and complex matrix environment and on cross-functional teams
• Ability to travel 30-40% of the time as needed (domestic and global), with the ability to spend some time in the argenx offices