Amgen Senior Associate Scientist in Shanghai, China
A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the promise of this emerging science to bring safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives.
Amgen is seeking Scientist - In Vitro Diagnostics based in Shanghai, China in Clinical Biomarkers & Diagnostics under Translational Medicine, Global Development.
Integral to the ongoing success of Amgen’s comprehensive biomarker programs, In Vitro Diagnostics (IVD) group is responsible for the transition of exploratory biomarkers to marketed IVDs, working with other functions within Amgen to identify the appropriate partner for diagnostic test development. The role uses a wide breadth of communication expertise across a broad range of stakeholders, influencing decision-making through negotiation, and addressing conflict by building productive working relationships across functional areas both within and outside the company.
Advise on the China and APAC regional Dx development strategy under global strategy, working closely with global Dx strategy leads. Facilitate regional Dx landscape, regulatory policy assessment and Dx partner due diligence and selection with cross-functional teams (e.g. Regulatory Affairs, Clinical Development, Strategic Planning).
Align with regional Project Team (PT) to identify development needs and timeline requirement. Coordinate communication and alignment between global Dx Development Team (DxDT) and local PT as program local Dx representative.
Responsible for Dx development part of the document drafting and review, including clinical study protocol, ICF, briefing book, contract/SOW with Dx partners, IVD study summary, HGRAC application, etc.
Manage third party companion diagnostic partners to develop Dx project plans including resource identification, budget, facility and regulatory requirements to meet project goals and timelines.
Lead the supervision of third party Dx partners on all aspects of IVD/CDx/LDT execution with cross-functional teams, to ensure quality and timely delivery of Dx approval or LDT implementation.
Facilitate the Dx partner lab and CRO lab evaluation with global planning and vendor performance evaluation team on technical capability, staff qualification and contribute to the technical part of the evaluation report.
PhD's degree in a scientific discipline with a minimum of 3 years industry experience in a diagnostic, or contract research organization focusing on Companion Diagnostics (CDx) or In Vitro Diagnostics (IVD)technical development
Master's degree in a scientific discipline with a minimum of 6 years industry experience in a diagnostic, or contract research organization focusing on Companion Diagnostics (CDx) or In Vitro Diagnostics (IVD) technical development.
Advanced degree with direct industry experience in developing diagnostic assays, or other role involving significant technical development in a partnership.
Preference for candidates with experience in general medicine and/or oncology diagnostic tests and the diagnostics development process. Knowledge of health authority regulatory submission process in China and APAC will be a strong plus. Strong understanding of pharmaceutical and diagnostic development phases. Proven pharma-facing experience developing and launching companion diagnostics in alignment with drug development programs.
Good knowledge of diagnostic technologies, including immunoassay, PCR, immunohistochemistry (IHC), next generation sequencing (NGS) and flow cytometry.
Demonstrated management experience, with the ability to lead multiple activities and resources while maintaining attention to details. Ability to lead, align, motivate, cross-functional, and geographically dispersed stakeholders.
Strong communication and influencing skills. Self-directed, innovative and collaborative spirit, flexible to adapt to a dynamic environment, and resourceful.
Ability to travel (up to 10% of time).
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.