Clinical Trial Physician (CTP)

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. 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...