Medical Affairs and Evidence Generation Asset Lead – Executive Director

argenx

4d•Remote

About The Position

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases. We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients. 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 FB-102, a molecule recently entering the argenx pipeline via the acquisition of Forte Biosciences. FB-102 is a first-in-class anti-CD122 monoclonal antibody designed to selectively modulate pathogenic T-cell and NK-cell activity that drives autoimmune disease. Through its differentiated mechanism of action, FB-102 has the potential to provide targeted treatment across a range of autoimmune conditions with current development efforts ongoing in celiac disease, vitiligo, and alopecia areata.

Requirements

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 to achieve indication/molecule goals with a proven track record of delivering results that meet or exceed targeted objectives
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. Able to balance short-term and long-term goals. Changes approach or method to best fit the situation. Able to deal with change, delays, or unexpected events.
Understands the value of co-creation and collaboration across functions with an ability to seek input from multiple stakeholders and across multiple geographies.
Can balance team and individual responsibilities. Gives and welcomes feedback. Contributes to building a positive team spirit. Understands the value of the team’s success vs one’s own interests. Supports everyone's efforts to succeed. Able to coach and develop people and values the empowerment of others.
Strong problem-solving skills with a proactive, solution-oriented mindset. Able to create solutions by developing options with innovative thinking.
Detailed understanding of regulations and practices, including related to industry interactions with healthcare professionals and product access
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
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

Nice To Haves

Knowledge of drug development and an existing expert network is an advantage

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 (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 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 but not limited to 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; communicate with the Community regularly about the asset’s development strategy and plans
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 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 work
Ensure all medical affairs activities maintain the highest standards, comply with applicable pharmaceutical regulation, as well as argenx policies and procedures