Career Category

Job Description

Responsibilities:

• 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

• Medical Doctor
• 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

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.