岗位职责:
• Serve as the China Clinical Lead for a designated asset, accountable for clinical strategy, key medical decisions, and overall delivery across the development lifecycle.
• Lead and manage multiple China clinical projects/studies under the asset (e.g., across phases and/or indications), driving integrated plans, timelines, milestones, and resource alignment.
• Partnering with Clinical Operations, Regulatory Affairs, Pharmacovigilance, Biostatistics, Data Management, Quality, and other stakeholders to ensure high-quality execution and issue escalation/risk mitigation.
• Oversee therapeutic area clinical strategy and evidence generation planning in China, incorporating disease landscape, standard of care, and competitive intelligence to inform study design and portfolio priorities.
• Ensure alignment of China clinical activities with global development strategy and compliance with local regulatory/ethical requirements, supporting NMPA interactions and registration-enabling submissions.
• Lead the drafting and quality oversight of key clinical documents for regulatory submission, including but not limited to the Clinical Overview/Clinical Summary, integrated analyses and benefit–risk justification for submission, clinical rationale supporting the label/prescribing information, and clinical Q&A materials.
资历要求: