Career Category

Clinical Development

Job Description

Sr Medical Advisor

Accountability:

• Provide local medical landscape section in support of Regulatory filing for clinical trial application, and China participation of global clinical study
• Supporting the development, execution and communication of the global clinical plan
• Leading the China Biosimilar product group and, where necessary, supports the countries in navigating products through internal and external governance and regulatory portals
• 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
• Supports regulatory and ethics approvals for China local trials
• Engages with relevant individuals including thought leaders, institutions and societies to generate medical insight.
• 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
• Coaching, mentoring and developing staff and team members

Key Qualification and Capabilities

• Medical Doctor
• 2 years or more clinical practice experiences in Rheumatology or Oncology
• 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: Rheumatology or Oncology
• 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.

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