Clinical Research Physician
HybridShanghai, Shanghai, China
Job Summary
Lead China local development project teams to propose development strategies and clinical pathways for new compound registration. Assess trial opportunities, prioritize diseases and compounds, and provide scientific inputs to global TPPs. Design clinical development plans and protocols ensuring local regulatory compliance, while initiating medical activities like surveys, Ad Board meetings, and KOL visits. Collaborate with Regulatory Affairs to develop registration pathways and generate filing materials, and establish partnerships with Chinese academia and key study centers. Provide medical training to CDO and investigators, support global study teams with trial monitoring and data queries, and ensure seamless handover to medical affairs for launch activities. Maintain full compliance with national laws and AbbVie policies throughout the clinical trial lifecycle.
Required Qualifications
- Medical Degree
- Strong medical background of related TA area
- Some knowledge of the drug development process and the regulatory framework for clinical development
- Working experiences (≥ 3 years) in medical and clinical development group of pharmaceutical (or biopharmaceutical) company or equivalent clinical practice
- Understanding of the developmental program interplay among Regulatory Affairs, Clinical Development and Commercial objectives
- Insights to study design
- Good knowledge of data collection, management, analysis, and interpretation
- Strong verbal and written communication skills
- Ability to analyze and summarize scientific/clinical data
- Ability to develop recommendations that affect the conduct of trial and the content of regulatory documents
- Fluent spoken English
- Solid written English skills
Desired Qualifications
- Experienced in leading multiple, diverse clinical development programs
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