Clinical Bioanalysis Director
Department: Clinical Pharmacology
Job Title: Clinical Bioanalysis Director
Report to: SVP, Head of Clinical Pharmacology
- Oversee bioanalysis assay development, including supporting the early discovery research assay, establishing qualified or validated method for preclinical and clinical use, method transferring and monitoring CRO.
- Responsible for preclinical and clinical bioanalysis strategy planning and study design, data interpretation according to regulatory requirement (FDA and NMPA).
- Responsible for internal bioanalysis platform setup and management.
- Responsible for IND documentation of bioanalysis part.
- Undertake bioanalysis team leader and expertise role in project team and department.
- Effectively manage the people group of project specialists/managers. Extract and transform learnings from group member’s first-hand experience or external sources into SOP/working instruction or other training material.
- Serve as a major critical reviewer of immunogenicity reports used in both domestic and international new drug application and other clinical research documents about PK/PD/ immunogenicity tests.
- Evaluate the immunogenicity risk of new drug compounds and propose clinical immunogenicity research plan accordingly.
- Ph.D. or equivalent in Pharmacometrics, Clinical Pharmacokinetics, Clinical Pharmacology, or similar disciplines where quantitative pharmacology is emphasized.
- At least 8-10 years relevant experience.
- Master’s in chemistry analysis, bioanalytical chemistry or other related discipline. Advanced degree preferred.
- More than 5 years experience in industry, and over 3-year team manager experience, major in bioanalysis background.
- Experience in RNA analysis is a plus.
- Outstanding oral and written communication skills and ability to interface effectively with all levels.
- Excellent oral and written English; fluent in Chinese; able to independently use both English and Chinese to write documents and communicate with peers and experts.