Development Feasibility Mgr
3 days ago
**Key Responsibilities**
- Develop and maintain knowledge of external clinical trial environment and assess impact on study design and execution in SEA Hub
- Develop and maintain repository of Country Landscaping information (Country Site Intelligence Tool) to support operational delivery (e.g., site capabilities, performance, regulatory landscape, treatment patterns etc.) in SEA Hub
- Develop expertise and understanding of local country availability and clinical use of biomarkers and other -omics data which may impact key Amgen products and development programs
- Build internal/external stakeholder engagement aiming at identifying new investigators and maintaining relationship with experts in specific therapy areas
- Understand patient flows and referral pathways in support of global/local operational delivery
- Partner with global feasibility manager and global project management representatives to provide country landscaping data in SEA Hub for inclusion into the program and study design and to inform/support study placement, as applicable
- Select the sites strategically in SEA Hub to participate in a study based on information gathered through medical and operational assessment
- Use site intelligence and local cross-functional input for study-level operational planning in support of country commitments validation and potential site list identification in SEA Hub
- Ensure consistency of activities and development of best practices through leadership / participation in Global Development Feasibility Manager Forum
- Coordinate and analyze global/regional feasibility outputs and sharing these with global project management group
**Qualifications and Knowledge**
- BA/BS/BSc in life sciences
- Masters Degree, M.D., PharmD preferred
- Regional clinical trial management experience
- Regional operational performance measurement experience
- International collaboration experience
- Broad work experience in life sciences or medically related field, including clinical research experience in a biotech, pharmaceutical or CRO company
- Knowledge of local country and international clinical trial management (including regulations & guidelines)
Join Us
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
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