Clinical Assay Lead, Manager (Contractor), Shanghai or Beijing
Core
Lead and oversee the lifecycle management of PK, PD, immunogenicity, and biomarker analytical assays for small molecules and biologics in clinical drug development.
Role type
Senior IC Clinical Assay Lead (Manager level)
Builds
Regulatory compliant bioanalytical data and reports for clinical studies
Domain
Clinical Pharmacology / Bioanalysis
Required skills
PK/PD/Immunogenicity assay development and validation, LC-MS quantitation, flow cytometry, FISH, IHC, NGS, regulatory submissions, CRO management, GxP compliance, strategic planning
Preferred skills
Regulatory inspection experience, clinical trial design knowledge, mentoring experience
Technologies
LC/MS, HPLC/UPLC/GC, ELISA, ECL, Flow Cytometry, FISH, IHC, NGS, RT-PCR, qPCR, ELISPOT, AMS, FACs
Responsibilities
Execute analytical strategy and method design, manage CRO selection and audits, support clinical trial conduct and data setup, prepare regulatory submissions, develop best practices and policies
Seniority
Senior, hands-on IC with management responsibilities