Career Category

Job Description

• Works with inter-disciplinary teams including global development/study operations teams, development design center, biostatistics, etc. to ensure preparation, implementation and completion of AST’s (Amgen sponsored studies)
• Develops study protocols and data analysis plans for Local  AST’s; supports and executes Local study protocol preparation, filing, review and approval in line with Amgen processes and policies
• Supports inter-disciplinary teams in participation and completion of International development studies in the country
• Participates in the development of International strategies and tactics in close collaboration with the regional and corporate medical, including publication plan, evidence generation plan
• Visits selected KOL’s and study groups for strategic discussions and protocol development
• Reviews Local ISS proposals prior to approval and ensures alignment with global scientific strategies, and works with global study operations to ensure appropriate review processes
• Partners with the BU Manager in the development and execution of the Local product(s) lifecycle management plan
• Provides input into site selection for AST’s
• Oversees in-sourced/outsourced Medical programs and logistics
• Supports Local regulatory and ethics approvals for development protocols
• Develops and executes better recruitment strategies in conjunction with local/regional study operation team
• Participates in/conducts Local Advisory Board Meetings, Investigator Meetings and/or Expert Panels
• Provides Medical expertise for Health Economy and reimbursement requests
• Keep up-to-date with responsible therapeutic area knowledge as well as local laws and regulations governing daily work

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.