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 . The Senior Clinical Trial Physician, Rheumatology, is the primary source of medical accountability and oversight for one or more clinical trials within the Global Drug Development organization. This position will provide the candidate an opportunity to significantly change the treatment of autoimmune diseases. They will be foundational in working with teams in Research, Early and Late Development, providing insights into biology, translational elements, as well as overall benefit risk assessments. The Senior Clinical Trial Physician sits within Clinical Development, which is a global organization dedicated to the effective design and execution of drug development. Clinical Development drives clinical development strategy, design, execution, and interpretation of clinical trials enabling market applications. The CTP will report directly to the Clinical Development Lead. Key Responsibilities Serves as a primary source of medical accountability and oversight for multiple clinical trials or a single trial with significant complexity within rheumatology Supervises the development, monitoring, analysis, and interpretation of clinical trials and will supervise and have accountability for the clinical components of regulatory filings. Provides medical and scientific expertise to cross-functional BMS colleagues Matrix management responsibilities across the internal and external network The role includes support of across portfolio activities in line with Clinical Excellence, including e.g. Protocol Review Committee and Quality and Compliance l Clinical Development Expertise & Strategy: A Clinical Trial Physician is a tenured drug developer who can independently design and construct clinical development plans and protocols with a strong strategic focus based on knowledge of asset/drug, disease area (rheumatology) and relevant science in order to meet regulatory and disease strategy targets. Done in conjunction with Clinical Development Lead Experience in Research and Development (late and/or early development) Oversees trial(s) within asset class Respected for Disease Expertise for rheumatology (internal to BMS and within the medical community) preferred Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment working with Clinical Scientists (CS) Partners with CS to support executional delivery of studies (e.g., site activation, enrollment status, as well as adjudication for protocol violations, significant, non-significant deviations etc.) Keeps abreast of development and regulatory issues related to other competitive or relevant compounds in development and how our portfolio fits into the competitive landscape The CTP should be able to anticipate impact of external data which may shift internal clinical strategy and proactively assess needs for internal program (ie amendments, need for ad hoc analyses & implications to execution of internal programs) Provides ongoing medical education in partnership with collaborating Clinical Scientists to allow for protocol-specific training, supporting the study team, investigators, and internal stakeholders (ie medical affairs, commercial, translational medicine, access, etc) Medical Monitoring: Leader of high performing Study Delivery Team (SDT) Study-Leader with ability to own/drive study level strategic decisions Medical data review of trial data, including eligibility review Holds responsibility for site interactions in partnership with the Clinical Scientist (CS) 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 collaborat