Clinical Development Indication Lead - Rheumatology
The Clinical Development Indication Lead will lead the clinical team for an 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. This person 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:
1. Provide continuous strategic medical insight and planning for the indication during all the stages of development
2. Own the Clinical development plan and participate in long range strategic planning as data emerges in the indication
3. 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
4. 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
5. 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
6. Lead indication medical ad 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 with rheumatology specialty education preferred ( other areas such as neurology, dermatology, immunology, internal medicine, pediatric are also of interest)
10. At least 3-5 years in the pharma/biotech industry, having acquired an in-depth understanding of end to end ( phase I to registration) drug development
11. Excellent English, both written and spoken is a must, as well as ability to travel
12. Proven leadership, motivational and interpersonal skills in a global and intercultural environment, including leading through influence
13. Pro-active problem solver with negotiation skills
14. Must provide clear vision, direction, and purpose to the different study teams
15. Demonstrated expertise in clinical trial design, conduct and interpretation of clinical data
16. Strong communication skills to ensure that study plans and status are transparent, and that risks, issues, and results are clear to all involved parties.
17. Additional skills in gathering decision information, negotiation and communicating decisions and action
18. Executes responsibilities with knowledge, accuracy, persistence, resilience and creativity, being an accomplished team player whilst maintaining medical integrity
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.