Career Category

Job Description

Amgen Job Description

Responsibilities

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, Biomarkers & Diagnostics, based in Shanghai, China under Translational Medicine, Global Development. Integral to the ongoing success of Amgen’s comprehensive biomarker programs, Clinical biomarkers and diagnostics (CBD) group is responsible for the development from biomarkers to marketed IVDs, working with other functions within Amgen to identify the appropriate partners for biomarkers and 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.

• Guide and operationalize the China Dx development strategy, working closely with global Dx strategy leads. Contribute to 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).
• 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 CDx approval or LDT implementation.
• Responsible for China trial biomarker study planning, including but not limited to drafting and review of briefing book, clinical study protocol, ICF, contract/SOW CROs, HGRAC application and study summary & report.
• Subject matter experts for assay qualification/validation for clinical biomarker assays performed in China and JAPAC. Responsible for coordinating with Global Biomarker Leads - to maximize JAPAC regional alignment of assay parameters in global studies.
• Responsible for biomarker CRO Lab evaluation and selection covering all China development portfolio. Technical management of selected CRO’s, including final data QC.

Basic Qualifications

Preferred

Qualifications

• PhD's degree in a scientific discipline with a minimum of 5 years industry experience in a pharmaceutical or diagnostic company, or contract research organization focusing on clinical biomarker and/or Companion Diagnostics (CDx) technical development
• Master's degree in a scientific discipline with a minimum of 8 years industry experience in a pharmaceutical or diagnostic company, or contract research organization focusing on clinical biomarker and/or Companion Diagnostics (CDx) technical development.

• Advanced degree with direct industry experience in developing biomarker/diagnostic assays, or other roles involving significant technical development.
• In-depth knowledge of diagnostic technologies, including immunoassay, PCR, immunohistochemistry (IHC), next generation sequencing (NGS) and flow cytometry.
• Strong understanding of pharmaceutical and diagnostic development phases. Proven experience developing and launching companion diagnostics in alignment with drug development programs. Knowledge of Dx regulatory guidelines and health authority regulatory submission process in China is a strong plus.
• Strong communication and influencing skills. Self-directed, innovative and collaborative spirit, flexible to adapt to a dynamic environment, and resourceful.
• 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.
• Ability to travel (up to 10% of time).

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission – to serve patients. We respect one another, recognize contributions, and have embedded

collaboration, trust, empowerment and inclusion in all that we do.