What are the responsibilities and job description for the Pediatric Indication Lead position at Argenx?
The Pediatric Indication Lead will lead the clinical team for the indication, translating the TPP as set by the Asset Strategy Team into a Clinical Development Plan that answers the relevant questions safeguarding time, quality, and budget. The Pediatric Indication Lead will work in close collaboration with the other members of the cross functional team, in order to maximize the potential of the asset for a given indication.
Roles and Responsibilities:
- Provide continuous strategic medical insight and planning for the indication during all the stages of development
- Own the Clinical development plan and participate in long range strategic planning as data emerges in the indication
- Line management of the Global Clinical Trial Physicians working on the indication. Provide coaching and set example for team ensuring high quality medical support for the study teams
- 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 with relevant specialty education preferred ( e.g. neurology, hematology, dermatology , immunology, rheumatology, internal medicine, pediatric)
- At least 3-5 years in the pharma/biotech industry, having acquired an i n-depth understanding of end to end ( phase I to registration) drug development
- Excellent English, both written and spoken is a must, as well as ability to travel
- Proven leadership, motivational and interpersonal skill s in a global and intercultural environment , including leading through influence
- 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.
- Additional skills in gathering decision information, negotiation and communicating decisions and action
- Executes responsibilities with knowledge, accuracy, persistence, resilience and creativity , being an accomplished team player whilst maintaining medical integrity
Job Type: Full-time