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About the role
Key responsibilities & impact- Provide leadership and experience in conducting early clinical research in China.
- Develop products towards registration, including study protocol, engaging key opinion leaders, drafting study reports, and preparing regulatory submissions.
- Collaborate with headquarter project teams and clinical trial operations for the execution of early studies.
- Represent clinical development team and address issues/questions raised by headquarters team from China perspective.
- Drive study design, collaborate with biostatisticians and regulatory affairs to construct high-quality clinical study protocols.
- Review and prepare clinical study reports and regulatory dossiers.
Requirements
What you’ll need- A PHD/Master in clinical medicine (at least 5-year medical school graduates) with postgraduate training in oncology or relative major.
- Deep understanding of China regulatory environment and clinical development procedure.
- Previous experience of clinical research/clinical development is highly desirable, including strategy development, medical monitoring, and protocol/ writing.
- Strong leadership, excellent written and oral communication skills, and project management skills.
- Strong capability of work prioritization and deliver results with parallel multiple tasks.
- Excellent language skills in both English and Chinese (fluent in verbal and written).
Benefits
Comp & perks- Flexible Work Arrangements: Not Applicable
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical researchstudy protocol developmentregulatory submissionsclinical study report writingmedical monitoringstrategy developmentbiostatistics collaborationprotocol writing
Soft Skills
leadershipwritten communicationoral communicationproject managementwork prioritizationmultitasking
Certifications
PhD in clinical medicineMaster in clinical medicine
