Bristol Myers Squibb Clinical Trial Lead in Princeton, New Jersey
The Clinical Trial Lead works with stakeholders across the organization to design and implement strategically aligned, efficient clinical trials that meet ethical, scientific, safety, regulatory, and commercial objectives. The Clinical Trial Lead reviews and interprets clinical data, and guides appropriate recommendations and decisions, and contributes substantially to regulatory submissions.
· Works with the Orencia Program Team Lead, the Full Development Team Lead, and matrix team members to translate the Orencia FDT strategy into protocols and action plans.
· Works with the relevant leaders to author clinical protocols and related documents, including clinical study reports, clinical regulatory documents including integrated summaries and clinical overviews.
· In collaboration with pharmacovigilance, designs and implements safety monitoring plans
· Provides key contributions to clinical documents and deliverables in support of regulatory submissions.
· Monitors one or more clinical trials for safety and experimental rigor
· Reviews and cleans data from clinical trials
· Addresses relevant clinical queries from study sites and authors responses to study related IRB and HA questions
· Cultivates relationships with thought leaders and investigators, and gathers input on disease areas and design of clinical programs.
· Provides clinical support to medical affairs and commercial colleagues
· MD, PhD, MD/PhD required, preferably with a deep understanding of immunology and autoimmune disease. Expertise in rheumatology or transplant preferred.
· At least 10 years of experience in clinical or translational research or in clinical practice in a relevant field, such as rheumatology or transplant.
· Understanding of the fundamentals of protocol development and execution, including but not limited to study monitoring, data collection and analysis, database cleaning and database lock.
· Able to work consistently in a matrixed environment with relevant teams such as operations, statistics, regulatory, pharmacovigilance and biomarkers.
· Able to lead multiple, complex, studies in parallel
· Exhibits capable team leadership
Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.