Director, Global Clinical Physician - Early HOCT

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Position Summary

· Serves as a primary source of medical accountability and oversight for multiple clinical trials

· Manages Phase I/II studies, with demonstrated decision making capabilities,

· Provides medical and scientific expertise to cross-functional BMS colleagues,

· Maintains matrix management responsibilities across internal and external networks

Duties/Responsibilities

Medical Monitoring

· Serves as an independent Medical Monitor for clinical trials from Phase 1 through Proof-of-Concept by: Articulating clinical development strategy, Analyzing, interpreting, and acting on clinical trial data to support development, Serving as principal functional author for Regulatory submission, study reports, and publications

· Provides oversight and medical accountability for multiple trials across early development clinical lifecycle

· Manages site interactions in partnership with the Clinical Scientist for medical questions and education (including safety management guidelines)

· Assesses key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees contributions to safety narratives

· Contributes to and is a key member of a high performing Study Delivery Team (SDT) and may be a member of the Development Team

· Collaborates with Clinical Scientists and provides input into protocols, contributing 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

· Acts as a focal point for defining and establishing relationships with key global Phase I Centers

· Works on multiple trials across early development clinical lifecycle

Clinical Development Expertise & Strategy

· Designs and develops clinical studies and research plans in support of asset strategy with the Early Clinical Development Leadership team; clinical studies include first-in-human Phase I, proof of concept Phase I/II, entry registrational studies, biomarker qualification studies, and/or clinical pharmacology studies

· Liaises with Clinical Scientists, Translational & Discovery Scientists and Development Teams to define dose and schedule, indications, and patient selection (e.g., biomarker qualification and implementation)

· Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment working with Clinical Scientists.

· Partners with Clinical Scientists to support executional delivery of studies (e.g., site activation, enrollment status, as well as adjudication for protocol violations, significant, non-significant deviations etc.)

· Maintains a strong medical/scientific reputation within the disease area; has in-depth knowledge of etiology, natural history, diagnosis, and treatment of the disorder

· Keeps up to date in the disease area by attending scientific conferences and ongoing review of the literature

· Clinical Development Expertise & Strategy

· Designs and develops clinical studies and research plans in support of asset strategy

with the Early Clinical Development Leadership team; clinical studies include first-in-human Phase I, proof of concept Phase I/II, entry registrational studies, biomarker qualification studies, and/or clinical pharmacology studies

· Liaises with Clinical Scientists, Translational & Discovery Scientists and Development Teams to define dose and schedule, indications, and patient selection (e.g., biomarker qualification and implementation)

· Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment working with Clinical Scientists

· Partners with Clinical Scientists to support executional delivery of studies (e.g., site activation, enrollment status, as well as adjudication for protocol violations, significant, non-significant deviations etc.)

· Maintains a strong medical/scientific reputation within the disease area; has in-depth knowledge of etiology, natural history, diagnosis, and treatment of the disorder

· Keeps up to date in the disease area by attending scientific conferences and ongoing review of the literature

Health Authority Interactions

· Contributes to key Health Authority interactions and advisory board meetings as Early Clinical Development Physician; serves as Primary Clinical Representative in Regulatory interactions for early development projects

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