第一三共
经理/副总监,临床开发-妇瘤-北京/上海
Skills
ComplianceRisk Management
24 days ago
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Important information
Contract type:
Permanent
Salary:
CN¥420,000 – CN¥780,000 / year
Location:
Beijing, China
Work mode:
Onsite
Published on:
2 October 2026
What they need
该职位来源于猎聘 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: 1、Clinical medicine with master degree or above, or has at least 3 years physician experience. At least 5 years in clinical development in pharmaceutical company. 2、Industry experience in oncology clinical development in gynecological oncology; Majored in gynecological oncology is preferred; Gynecological oncology clinical work experience in hospital is preferred. 3、Excellent language skills in both English and Chinese (fluent in verbal and written) 4、Good collaboration with cross functional team; Strong capability of work prioritization and deliver results with parallel multiple tasks 5、Good command of computer
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