Clinician, Senior Manager

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About the role

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 Pfizer is an equal opportunity employer and complies with all

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