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Bei Bristol Myers Squibb lassen wir uns von einer einzigen Vision inspirieren - die Veränderung des Lebens von Patienten durch Wissenschaft. In den Bereichen Onkologie, Hämatologie, Immunologie und Herz-Kreislauf-Erkrankungen - und eine der vielfältigsten und vielversprechendsten Pipelines der Branche - trägt jeder unserer leidenschaftlichen Kollegen zu Innovationen bei, die bedeutende Veränderungen vorantreiben. Wir verleihen jeder Therapie, für die wir Pionierarbeit leisten, eine menschliche Note. Kommen Sie zu Bristol Myers Squibb  und machen Sie einen Unterschied. Medical Monitoring ·        Serves as a core member of the Study Delivery Team (SDT) and may contribute to the Clinical Development Team (CDT) ·        Leads ongoing medical review of clinical trial data, including eligibility and key safety data review ·        Drives cross-functional alignment with Clinical Operations, Clinical Pharmacology, Translational Medicine, Biometrics, and Worldwide Patient Safety to ensure timely data review and robust risk mitigation ·        Provides end-to-end medical oversight for Phase 1 FIH dose escalation/expansion to Phase 2 and Phase 3 (e.g., study design, medical monitoring, data review, data interpretation, etc.), including real-time emerging safety signal review, DLT assessment, and dose decision support ·        Leads and/or supports Safety Review Committee (SRC)/Dose Escalation Committee activities, including preparation of safety packages, dose recommendation rationale, and decision documentation ·        Provide clinical input and insight to filing strategy and support data interpretation and filing activities, including the clinical dossier preparation and GCP inspection. ·        Partners with the Clinical Scientist (CS) and/or other relevant functions like clinical operation to address site medical questions and deliver protocol-with compliance and scientific sound ·        Assesses safety-related SAEs in partnership with Worldwide Patient Safety and oversees safety narratives ·        Provides medical strategic oversight for protocol development (e.g., key inclusion/exclusion criteria and other safety-related clinical considerations) in partnership with CS ·        Fulfills GCP and compliance obligations for clinical conduct and maintains all required training Clinical Development Expertise & Strategy ·        In collaboration with the Clinical Development Lead, designs and develops clinical plans and protocols based on asset/drug knowledge, disease area expertise, and relevant science to meet regulatory and disease strategy targets ·        Leads Phase 1 to Phase 3 protocol strategy and key design elements, including target population, treatment regimen, endpoints setting and intensive safety monitoring aligned with the Investigators Brochure and nonclinical package ·        Ensures China and global strategy alignment by partnering with Global Clinical Development, Global Program Teams, and relevant governance forums to incorporate regional inputs and maintain consistency of program decisions and messaging ·        Provides medical accountability and oversight for a group of studies across early studies as assigned ·        Leads benefit/risk analysis for clinical development protocols in a matrix team environment working with Clinical Scientists (CS) ·        Partners with CS, Clinical Operations, and other relevant functions to support study execution (e.g., site activation, enrollment status, and adjudication of protocol violations and deviations) ·        Contributes to early development regulatory interactions and submissions (e.g., IND/CTA modules and briefing packages) as a clinical/medical author and reviewer, partnering with Regulatory Affairs ·        Identifies and builds relationships with principal investigators and thought leaders to inform emerging science, biomarker strategy, and study/program design ·        Maintains a strong medical/scientific reputation within the disease area through conference participation and ongoing literature review ·        Provides ongoing protocol-specific medical education to study teams, investigators, and other stakeholders in partnership with CS Health Authority Interactions & Publications ·        Serves as the clinical point of expertise for key Health Authority interactions and advisory board meetings, ensuring alignment with global program strategy and consistency across clinical, regulatory, and safety messaging ·        Authors/drafts clinical content for CSRs, regulatory reports, briefing books and submission documents to support study closure and reporting in partnership with CSs Wir setzen uns auf der ganzen Welt leidenschaftlich dafür ein, das Leben von Patienten mit schweren Krankheiten zu beeinflussen. Unsere gemeinsamen Werte Leidenschaft, Innovation, Dringlichkeit, Verantwortlichkeit, Inklusion und Integrität befähigen uns, unsere individuellen Talente und unterschiedlichen Perspektiven in einer integrativen Kultur einzusetzen und bringen das höchste Potenzial jedes unserer Kollegen hervor. Bristol Myers Squibb weiß um die Bedeutung von Balance und Flexibilität im Arbeitsumfeld. Wir bieten daher eine Vielzahl von attraktiven Benefits, Dienstleistungen und Programmen an, die unseren Mitarbeitern die Ressourcen bieten, ihre Ziele sowohl bei der Arbeit als auch in ihrem Privatleben zu verfolgen. If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at [email protected] . Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley. R1604564 : Clinical Trial Physician (CTP)