Description
Lead or provide core clinical science support for Phase 1a/b and Phase 2a studies in Asia/China, including healthy volunteer. early patient trials, proof-of-concept studies, biomarker-driven studies,.
Contribute to early phase clinical development plans, protocol synopses, and protocols, with specific input on patient population, endpoint selection, dose strategy, PK/PD sampling, biomarker
integration, and stopping rules.
Provide medical and scientific oversight during study conduct, including review of eligibility questions, protocol deviations, emerging safety signals, and dose-escalation, dose-optimization, or
cohort-expansion decisions in collaboration with the study team.
Interpret and communicate early clinical data, including safety, tolerability, PK, PD, biomarker, and preliminary efficacy results, to assess mechanism, establish early proof-of-concept, and support
timely development decisions.
Work closely with global clinical science, clinical operations, biostatistics, translational medicine, pharmacovigilance, regulatory, and program leadership to ensure high-quality execution of early patient studies.
Provide regional input on feasibility, investigator and site strategy, patient recruitment considerations, and operational planning for early phase patient studies in China and the broader Asia/China region.
Support interactions with investigators, key opinion leaders, and regulatory authorities relevant to early phase patient development activities.
Contribute to preparation of study reports, governance materials, and internal decision documents that enable progression from early patient studies through Phase 2a and beyond.Lead or provide core clinical science support for Phase 1a/b and Phase 2a studies in Asia/China, including healthy volunteer. early patient trials, proof-of-concept studies, biomarker-driven studies,.
Contribute to early phase clinical development plans, protocol synopses, and protocols, with specific input on patient population, endpoint selection, dose strategy, PK/PD sampling, biomarker
integration, and stopping rules.
Provide medical and scientific oversight during study conduct, including review of eligibility questions, protocol deviations, emerging safety signals, and dose-escalation, dose-optimization, or
cohort-expansion decisions in collaboration with the study team.
Interpret and communicate early clinical data, including safety, tolerability, PK, PD, biomarker, and preliminary efficacy results, to assess mechanism, establish early proof-of-concept, and support
timely development decisions.
Work closely with global clinical science, clinical operations, biostatistics, translational medicine, pharmacovigilance, regulatory, and program leadership to ensure high-quality execution of early patient studies.
Provide regional input on feasibility, investigator and site strategy, patient recruitment considerations, and operational planning for early phase patient studies in China and the broader Asia/China region.
Support interactions with investigators, key opinion leaders, and regulatory authorities relevant to early phase patient development activities.
Contribute to preparation of study reports, governance materials, and internal decision documents that enable progression from early patient studies through Phase 2a and beyond.
Qualifications
Highest qualification: University
Hands-on experience in healthy volunteer and patient-based early phase clinical development is required, with clear experience supporting or leading Phase 1 and Phase 2a trials in patients.
Strong understanding of early phase patient study design and conduct, including dose selection, safety review, PK/PD interpretation, biomarker strategy, and early proof-of-concept evaluationin patients.
Experience in immunology drug development is preferred; broad or general immunology background is highly desirable.
Strong communication and matrix collaboration skills, with ability to work effectively acrossglobal and regional teams