Director, Global Clinical Physician - Early Clinical Development Oncology

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. 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 Authors/drafts clinical content for CSRs, regulatory reports, briefing books and submission documents to support closure, clinical narratives, reporting and filling of the study in partnership with Clinical Scientists External Partnerships, Alliances, and Publications Sits in team responsible for establishing key alliances with academic centers, co-operative groups, vendors and government agencies Represents department in business development due diligence and partner alliance management with oversight Acts as a focal point for defining and establishing relationships with key global Phase 1 Centers Track record or recognized for contributions to field (e.g., publications, patents, keynote participation in conferences etc.) Reporting Relationship Reports to: Executive Director, Early Clinical Development, Solid Tumors. Qualifications Advanced degree(s) in relevant field: MD, MD/PhD (or x-US equivalent) and clinical expertise in a therapeutic area (e.g., attending level or international equivalent) Subspecialty fellowship training in applicable therapeutic area preferred 5+ years of relevant experience in discovery, translational and/or clinical research in academic or industry setting including education where applicable Ability to communicate and present information clearly in scientific and clinical settings Expertise in the scientific method to test hypotheses, including statistical design, analysis, and interpretation Knowledge of drug development process Knowledge of 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 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. Compensation Overview: Brisbane - CA - US: $308,700 - $374,075 Cambridge Crossing: $308,700 - $374,075 Madison - Giralda - NJ - US: $275,630 - $333,998 Princeton - NJ - US: $275,630 - $333,998 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/li