This individual is responsible for bioanalysis activities in support to China clinical development of company’s portfolio. The individual will work closely with global bioanalysis team and China project team, to provide bioanalysis solutions for clinical studies conducted in China and ensure key deliverables on time. The candidate must have experience in small and/or large molecule regulated bioanalysis.

The individual will work on China bioanalysis activities with the support of global regulated bioanalysis and outsourcing team. He/She will be the main role coordinating between global and China teams to work out bioanalysis strategy for China. In the case of bioanalysis activity outsourced to China CROs, he/she will support global bioanalysis monitor to solve problems and issues for China, and oversee sample analysis and data transfer. In case of sample exportation, he/she will be the leading role to compose justification document to support sample exportation. He/she is responsible for bioanalysis content in China-specific document such as HGRAC submission document.

He/she also works with China project team on study planning for clinical bioanalytical work and enables data/report delivery from the CROs to the project teams on time. The position requires expert command of the bioanalytical scientific discipline and understanding of the regulatory requirements for GxP bioanalysis; planning and organization with CRO as well as ability to interface and resolve study-related issues. The position also requires a thorough understanding of bioanalysis in support of clinical trials, and a strong working knowledge of relevant Chinese regulatory requirements.

Responsibilities

• Work closely with global bioanalysis outsourcing team to provide bioanalysis solutions for China clinical development activities
• Coordination of China bioanalysis strategy which is aligned with global bioanalysis team and China project team
• Initiation of work on method transfer and (cross-) validation of bioassays, immunogenicity assays and analytical methods for the quantitative determination of protein therapeutics and small molecule drugs including metabolites in biological matrices in the context of clinical studies in different therapeutic areas in accordance with FDA, ICH, OECD and NMPA Guidelines
• Oversight of CROs for sample analysis, data generation, data transfer, reporting etc.
• Coordination between cross-functional teams to track local biosample and bioanalysis activities and ensure bioanalysis data generated on time
• Ensure compliance with the principles of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) according to global and local regulations
• Input and review bioanalysis related content in China-specific document, such as HGRAC submission forms
• Expert/Advisor on internal and external bioanalytical questions and issues
• Participation in local and global project teams
• Control, coordination, and contracting of studies performed externally.
• Review (translation of) the document generated from external labs to ensure quality and meet regulatory requirements
• Report writing and data transfer after completion of analytical work
• Responsible for sample exportation justification with support and input from global bioanalysis team if necessary
• Evaluate and assess China bioanalytical CROs if necessary