Clinical Scientist

Key ResponsibilitiesContribute to clinical development plans for in vivo gene therapy programs, from FIH through proof-of-concept.Draft and review key clinical documents, including protocols, IBs, and ICFs.Design monitoring and mitigation strategies for in vivo gene therapy-specific risks (immunogenicity, complement activation, hepatotoxicity, insertional mutagenesis).Ensure compliance with FDA, EMA, and NMPA requirements, ICH-GCP, and gene therapy guidelines.Serve as scientific lead at the study level, supporting site initiation, enrollment, and trial execution.Address medical questions from investigators and sites.Support safety surveillance: review AE/SAE reports, assist with causality assessment, and prepare for DSMB meetings.Liaise with CROs and external vendors on medical and scientific matters.Review safety and efficacy data, provide medical interpretation, and contribute to Go/No-go decisions.Contribute to clinical sections of IND/BLA submissions and support regulatory interactions (Pre-IND, Type B/C meetings).Work with Translational Medicine to integrate biomarker and immune monitoring data into clinical decisions.Track advances in in vivo gene therapy and evolving regulatory pathways.Qualifications1.Bachelor’s degree in biomedical science, pharmacology, biochemistry, medicine, or related field，3+ years of clinical research, clinical operations, or drug development experience2.Experience in clinical trial design & execution, ICH‑GCP compliance, statistical analysis, medical writing, data interpretation3.Protocol development, safety surveillance, cross‑functional leadership4.Soft skills:Critical thinking, communication, project management, problem‑solving, and collaborationPreferred: Direct experience in early drug development in rare disease with cell and gene therapy; ideally in a biotech environment.