Senior Clinical Trial Physician, Oncology

Role Summary

Senior Clinical Trial Physician, Oncology at Bristol Myers Squibb. Global clinical development role focused on design, execution, and interpretation of oncology trials from Phase 1 to Phase 3, providing medical oversight and cross-functional leadership to deliver strategic clinical development plans.

Responsibilities

• Serves as a primary source of medical accountability and oversight for multiple clinical trials
• Matrix management responsibilities across the internal and external network
• Manages Phase 1 - Phase 3 studies, with demonstrated decision making capabilities
• Provides medical and scientific expertise to cross-functional BMS colleagues
• Leads medical data review of trial data, including eligibility review
• Holds responsibility for site interactions in partnership with the Clinical Scientist for medical questions and education (including safety management guidelines)
• Holds responsibility for assessment of key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees safety narratives
• Leads collaboration with CS and inputs into protocols, providing medical strategic oversight in protocol development (input on inclusion/exclusion and other safety-related clinical considerations)
• Fulfills GCP and compliance obligations for clinical conduct and maintains all required training
• In collaboration with the Clinical Development Lead, designs and develops clinical plans and protocols with a strong strategic focus based on asset/drug, disease area and relevant science to meet regulatory and disease strategy targets
• Provides oversight and medical accountability for a group of studies
• Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment
• Partners with CS to support executional delivery of studies (site activation, enrollment status, adjudication for protocol violations, deviations)
• Identifies and builds relationships with principal investigators; cultivates thought leaders for inputs on emerging science
• Maintains a strong medical/scientific reputation within the disease area; keeps abreast of etiology, natural history, diagnosis, and treatment
• Keeps abreast of development and regulatory issues related to other compounds and portfolio landscape
• Provides ongoing medical education in partnership with Clinical Scientists to support protocol-specific training
• Contributes to and serves as medical point of expertise in Health Authority interactions and advisory board meetings
• Authors clinical content for CSRs, regulatory reports, briefing books, and submission documents

Qualifications

• MD required (or x-US equivalent)
• 5 or more years of Industry experience and/or clinical trials experience
• Ability to communicate information clearly and lead presentations in scientific and clinical settings
• Subspecialty training in applicable therapeutic area desired
• Expertise in the scientific method to test hypotheses, including statistical design, analysis, and interpretation
• Expertise in drug development process
• Expertise in the components needed to execute an effective clinical plan and protocols
• Strong leadership skills with proven ability to lead and work effectively in a team environment

Skills

• Medical monitoring and trial oversight
• Clinical development strategy and protocol design
• Stakeholder collaboration and cross-functional leadership
• Safety assessment and adverse event handling
• Regulatory and compliance acumen (GCP)
• Engagement with investigators and thought leaders

Education

• MD required (or x-US equivalent)

Additional Requirements

• Domestic and International travel may be required