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 one of our multiple indications, 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. This is done in close collaboration with the other members of this cross-functional team to maximize the potential of the asset for a given indication.
Roles and Responsibilities
1. Provide continuous strategic medical insight and planning for the indication during all stages of development.
2. Own and lead the Clinical Development Plan; participate in long-range strategic planning as data emerge in the indication.
3. Line management of the Global Clinical Trial Physicians working on the indication: coach and set an example for their roles, ensuring high-quality medical support for the study teams, identify high performers for potential other roles.
4. Real-time oversight of the medical aspects of studies in the indication, including communication to management and study teams as needed.
5. Safeguard harmonization across studies so that communications to external stakeholders (e.g. questions from IRBs, regulatory authorities) are consistent and company efficiency is maintained, in close collaboration with peers and management of different functional groups.
6. Lead indication-level medical advisory boards as appropriate.
7. Help build and maintain a best-in-class group of development medical doctors.
8. Ensure compliance of all studies in the indication.
Education, Experience and Qualifications
9. Medical Doctor; relevant specialty education (immunology experience preferred).
10. In-depth understanding of end-to-end (Phase I to registration) drug development based on at least 3–5 years of relevant experience in the pharma/biotech industry as well as clinical practice.
11. Clinical development experience in immunology preferred.
12. Excellent English, both written and spoken, as well as the ability to travel.
13. 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.
14. Proactive problem solver with strong negotiation skills.
15. Able to provide clear vision, direction, and purpose for the different study teams, while remaining sensitive to the diverse cultural needs of a global organization.
16. Strong communication skills to ensure that study plans and status are transparent, and that risks, issues, and results are clearly communicated to all involved parties.
17. A matrix structure requires additional skills in gathering decision information, negotiation, and communicating decisions and actions.
18. Executes responsibilities with knowledge, accuracy, persistence, resilience, and creativity; an accomplished team player who maintains medical integrity.
19. Demonstrated expertise in clinical trial design, conduct, and interpretation of clinical data.
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For applicants in the United States: The annual base salary hiring range for this position is $ 296.000,00 - $ 444.000,00 USD. This range reflects our good faith estimate at the time of posting. Individual compensation is determined using objective, inclusive, and job-related criteria such as relevant experience, skills, demonstrated competencies and internal equity. This means actual pay may differ from the posted range when justified by these factors. Because market conditions evolve, pay ranges are reviewed regularly and may be adjusted to remain aligned with external benchmarks.
This job is eligible to participate in our short-term and long-term incentive programs, subject to the terms and conditions of those plans and applicable policies. It also includes a comprehensive benefits package, including but not limited to retirement savings plans, health benefits and other benefits subject to the terms of the applicable plans and program guidelines.