Senior Manager, Senior Japan Clinical Lead
Core
Serve as the clinical point of accountability for the Japan Development Team, responsible for the overall Japan clinical development plan for asset(s) in one or more indication(s).
Role type
Senior Manager, Senior Japan Clinical Lead
Builds
Clinical development programs for pharmaceutical assets in Japan
Domain
Pharmaceutical clinical development in Japan
Required skills
Clinical development strategy, study design and execution, regulatory document preparation, GCP compliance, cross-functional leadership, data trend identification, protocol development, site training, clinical data review
Preferred skills
5+ years clinical development experience, expertise in registrational and non-registrational studies, matrix team experience, fluency in spoken and written English
Technologies
GCP/ICH, CRF design, DMC activities
Responsibilities
Accountable for clinical contribution to indication strategy; design, execution, and analyses of studies; clinical content for CSRs and regulatory documents; champion quality-focused mindset and GCP adherence; represent Clinical Development in internal and external forums; serve as Primary Clinical Representative in Regulatory interactions; set executional priorities with operation team; maintain understanding of protocols and educate team; evaluate innovative trial designs; identify study level risks; serve as CS in Japan local studies; lead trial level activities; plan study startup/conduct/close-out; develop clinical narrative plan; provide information for trial budget and CRO scope; review site and CRA training materials; coach Clinical Leads
Seniority
Senior Manager, hands-on IC with leadership responsibilities