Sr. Manager, Clinical Research
Core
Lead early clinical research programs in China, driving study design, protocol development, and regulatory submission to support global drug registration.
Role type
Senior Manager, Clinical Research Physician
Builds
Early clinical studies and regulatory dossiers for oncology and related therapeutic areas
Domain
Biopharmaceuticals / Clinical Development / Oncology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical Study Design, Clinical Trial Planning, Regulatory Compliance, Strategic Planning, Team Leadership, Medical Writing, ICH GCP Guidelines, Risk Management, Data Analysis, Site Initiation
Preferred skills
None stated
Technologies
None stated
Responsibilities
Develop China-specific clinical development plans and study protocols; Engage key opinion leaders and internal stakeholders; Interpret clinical and preclinical data to support study design; Prepare clinical study reports and regulatory responses; Review monitoring plans, data listings, and serious adverse events; Lead lab selection and clinical supply applications; Participate in due diligence evaluations for medical matters.
Seniority
Senior, hands-on IC with leadership responsibilities