Clinical Trial Physician (CTP)

Job description

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 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 If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. Supporting People with Disabilities BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. 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