Global Medical Indication Lead

2 weeks ago

Boston, United States argenx Full time

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.

It is an exciting time of growth for argenx as we strive to achieve our VISION 2030. 'Vision 2030' includes the following goals: 50,000 patients globally on treatment with an argenx medicine, 10 labeled indications across all approved assets, including VYVGART and potentially empasiprubart, ARGX-119 and five new molecules in Phase 3 development.

The Global Medical Indication Lead leads Clinical Development for the ARGX-119 ALS indication: translating the Target Product Profile (TPP) as set by the Asset Strategy Team into a Clinical Development Plan that answers the relevant questions safeguarding time, quality and budget, in close collaboration with the other members of this cross functional team, in order to maximize the potential of the Asset for a given indication.

This is a hybrid role and will have frequent trips to the Boston office. EST time zone preferred.

Roles and Responsibilities:

  • Provide continuous strategic medical insight and planning for the indication during all the stages of development

  • Own and lead the Clinical development plan. Participate in long range strategic planning as data emerge in the indication

  • Line management of the Global Clinical Trial Physicians working on the indication: coach and set example for their roles ensuring high quality medical support for the study teams, identify high performers for potential other roles

  • Real time oversight of the medical aspects of studies in the indication including the relevant communication to management as well as the different study teams

  • Safeguard harmonization across the studies so that communications to external stakeholders (e.g. questions of IRBs, RAs) are consistent and company efficiency is maintained in close collaboration with peers as well as management of the different functional groups

  • Lead indication medical ad boards as appropriate

  • Help build and maintain a "best in class" group of development medical doctors

  • Ensure compliance of all studies in the indication

Education, Experience and Qualifications:

  • Medical Doctor; relevant specialty education (Neurology/Neuromuscular, with ALS experience preferred), having acquired in-depth understanding of end to end (phase I to registration) drug development based on relevant experience of at least 3-5 years in the pharma/biotech industry as well as clinical practice. Clinical Development experience in ALS preferred

  • Excellent English, both written and spoken is a must, as well as ability to travel

  • Proven leadership, motivational and interpersonal skills in a global and intercultural environment, including leading through influence (without having direct reporting lines), and managing direct reports

  • Pro-active problem solver with negotiation skills

  • Must provide clear vision, direction, and purpose to the different study teams, demonstrated expertise in clinical trial design, conduct and interpretation of clinical data

  • Strong communication skills to ensure that study plans and status are transparent, and that risks, issues, and results are clear to all involved parties. A matrix structure requires additional skills in gathering decision information, negotiation and communicating decisions and action

  • Executes his/her responsibilities with knowledge, accuracy, persistence, resilience and creativity, being an accomplished team player whilst maintaining medical integrity

  • Demonstrated expertise in clinical trial design, conduct and interpretation of clinical data

#LI-Hybrid

At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.

If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at hr.us@argenx.com. Only inquiries related to an accommodation request will receive a response.

PDN-9db020e3-2e58-4d1c-97ee-33f915de945a

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