Amgen Sr Medical Advisor-CV in Shanghai, China
Lead and develop product medical strategy and plan based on product strategy.
Key member to develop product strategy and LCM with brand team.
Provide China position on global/region disease and product related programs.
Provide medical affair consideration on portfolio evaluation and discussion.
Lead evidence generation and publication plan and execution.
Partners with the brand team in the development and execution of the Local product(s) lifecycle management plan
Leading and developing the Local Medical strategy and Medical activities for the product(s) in accordance to internal and external regulations
TA and/or product specific Medical training
Ensuring consistency of Medical content and scientific messages across various tools and materials
Visits selected KOL’s and study groups for strategic discussions and protocol development
Develops study protocols for Local AST’s (Amgen sponsored studies); supports and executes Local study protocol preparation, filing, review and approval in line with Amgen processes and policies
Works with GSO to ensure preparation, implementation and completion of AST’s
Supports GSO in participation and completion of global/region studies in the country
Reviews Local ISS proposals prior to approval and ensures appropriate Local/region/global committee review, if applicable
Provides input into site selection for AST’s
Oversees in-sourced/outsourced Medical programs and logistics
Participates in/conducts Local Advisory Board Meetings, Investigator Meetings and/or Expert Panels
Provides Medical expertise for pipeline products
Provides Medical expertise for Health Economy and reimbursement requests
Basic Qualifications Selection Criteria (minimum Qualifications)
Minimum of 2 years in pharmaceutical industry, or proven industry collaboration in academia
Experience in Medical Department or Clinical Development
Experience with clinical study management and conduct
Knowledge of commercialization and business practices
Fluent in Chinese (Mandarin) and English
Preferred Qualifications Preferred Requirements
MD, PharmD or PhD is required
Knowledge of pharmaceutical product development, product lifecycle and commercialization process with advanced understanding of other functions; including, but not limited to, Clinical Operations, Commercial, Regulatory, and Medical Affairs
Therapeutic area knowledge
Network of customer contacts in therapeutic area
Finance and budgeting experience
Medical and scientific expertise
Fluency in English, both oral and written communications
Strong communication and presentation skills
Continuously expanding medical and scientific knowledge as well as market knowledge
Strong clinical research knowledge (study design, study evaluation, medical writing skills, expert panel conduct, symposium and workshop management, KOL management)
Strong customer orientation; science-based
Ability to work in a cross-functional team (e.g., Commercial, Clin Development, EU teams, HE, Regulatory, Safety, etc.)
Role model for others in line with Amgen Values
Demonstrates leadership skills
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.