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The Medical Advisor will lead post-marketing clinical research and real-world evidence (RWE) initiatives to optimize product lifecycle management. This role requires integrating scientific expertise with strategic insights to generate robust evidence supporting product safety, efficacy, and value in real-world settings. The candidate will collaborate cross-functionally to drive data-driven decision-making and ensure alignment with regulatory and market needs.
Post-Marketing Clinical Research & RWE Strategy
Design and execute post-marketing studies (Phase IV), including protocol development, data analysis, and interpretation of results to address clinical gaps and regulatory requirements
Lead real-world evidence projects (e.g., observational studies, database analyses) to evaluate treatment patterns, comparative effectiveness, and long-term outcomes
Collaborate with biostatistics and data science teams to apply advanced analytics (e.g., R, SAS) for RWE generation
Cross-Functional Collaboration
Partner with Market Access to develop value propositions using RWE for reimbursement and health technology assessments (HTA)
Support R&D activities as needed
KOL Engagement & Scientific Communication
Build and maintain relationships with Key Opinion Leaders (KOLs), facilitating advisory boards and expert panels to gather clinical insights and drive research priorities
Compliance & Risk Management
Ensure adherence to GCP, regulatory guidelines (e.g., FDA, NMPA), and internal SOPs in all research activities
Monitor and assess safety signals from post-marketing data, collaborating with Pharmacovigilance for risk mitigation
MD, PhD, or master’s degree in clinical medicine, Pharmacology, Epidemiology, or related fields
3+ years in pharmaceutical industry roles (Medical Affairs, Clinical Research) with focus on post-marketing studies/RWE
CNS Disease Experience would be a plus
Proven track record in study management
Expertise in real-world data sources (e.g., claims databases, EHRs)
Strong understanding of regulatory landscapes (e.g., ICH-GCP, RWE guidelines)
Excellent communication skills in English; proficiency in local language preferred
Computer literacy: Fluent Microsoft Office operation skills
Director, Medical Affairs Greater China
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