Provide disease expertise to solid tumor TA and work out a fit-China development strategy
Lead the China Early Subteam to drive the planning processes, data generation, establishing and communicating the medical strategy for the China early solid tumor projects
Provide clinical / scientific input during the development and execution of clinical trials
Interpret clinical trial data
Support product lifecycle management
Author regulatory submissions and publications, and participate China healthy authority interaction
Supports regulatory and ethics approvals for China local trials
Engages with relevant individuals including thought leaders, institutions and societies to generate medical insight.
Update local affiliate and regional stakeholders on product strategy and key issues to inform pre-launch plan
Organizes and / or conducts Medical Advisory Boards Meetings / Expert Panels and participates in Investigator Meetings
Responsible for data review and participates in KOL / Trial speaker development
Key Qualification and Capabilities
2 years or more clinical practice experiences
2 or more years of clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical) or significant interest in one or more of the following therapeutic areas : lipidology, cardiovascular disease, diabetes
Experience with clinical study management and conduct
Experience with scientific expert interactions
Fluency in English, both oral and written communications
Familiarity with concepts of clinical research and clinical trial design, including biostatistics
Knowledge of Good Clinical Practices (GCP), FDA, EMEA / CHMP and CFDA regulations and guidelines, and applicable international regulatory requirements
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.