锦鲤求职岗位描述
The Clinician is accountable for the medical and scientific integrity of one or more clinical trials and for the safety and well-being of study participants. The role applies clinical and scientific expertise to design, execute, monitor, and interpret clinical studies while ensuring operational excellence, quality, compliance, and timely delivery of program objectives. The Clinician serves as the primary medical contact for investigators and study teams on protocol-related clinical matters.
Key Responsibilities
Clinical Development and Study Design
Contribute to Protocol Design Documents (PDDs) and protocol development.
Lead or support protocol authoring and optimization.
Apply clinical and quantitative design principles to improve study efficiency and quality.
Partner with cross-functional stakeholders during governance review and approval processes.
Clinical Trial Execution
Provide ongoing medical oversight for clinical studies.
Review clinical data, safety signals, and protocol deviations.
Support implementation of risk mitigation strategies.
Ensure studies are conducted in compliance with internal standards, ICH-GCP, and applicable regulations.
Medical Monitoring and Safety Management
Perform or support medical monitoring activities.
Review adverse events, emerging safety issues, and patient-level data.
Participate in Safety Review Plans and Risk Management activities.
Support Data Monitoring Committees (DMCs) and Endpoint Adjudication Committees.
Data Interpretation and Reporting
Provide clinical input into SAPs, TLFs, clinical study reports, and related documentation.
Support interpretation and communication of clinical trial results.
Ensure scientific rigor and data quality throughout the study lifecycle.
Investigator and Stakeholder Engagement
Serve as the primary medical/scientific contact for investigators.
Support investigator meetings and protocol-related discussions.
Respond to clinical and medical questions from internal and external stakeholders.
Basic Qualifications
MD Clinician
Medical degree (MD or equivalent).
Clinical practice and/or drug development experience.
Strong knowledge of clinical development, safety monitoring, and regulatory requirements.
Non-MD Clinician
Bachelor's degree or equivalent (advanced degree preferred).
4+ years of experience in biopharmaceutical clinical research and development.
Extensive knowledge of clinical development, global/regional regulations, and ICH-GCP.
Strong project management and communication skills.
Core Competencies
Medical and Scientific Excellence
Demonstrated expertise in clinical development and lifecycle strategy.
Ability to discuss scientific, clinical, regulatory, and commercial considerations.
Strong disease area knowledge and scientific credibility.
Accountability
Takes ownership of study deliverables and results.
Drives execution and achieves key milestones.
Teamwork and Leadership
Fosters collaboration across functions.
Supports team success and capability development.
Demonstrates effective stakeholder management.
Change Agility
Adapts effectively to changing business and development environments.
Maintains performance in complex and ambiguous situations.
Typical Scope in Development China
A Clinician (Senior Manager) may lead or support:
China CTA preparation and submission
Protocol and amendment development
Medical monitoring activities
KOL and investigator engagement
Clinical data review and interpretation
CSR and NDA support
Cross-functional collaboration with Global Study Teams
China-specific development strategy input
Work Location Assignment: Hybrid
辉瑞是平等机会的雇主，并且在其运营的每一个司法管辖区遵守所有适用的平等就业机会立法。
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Medical