Senior Clinical Trial Physician
Expiry Date :
Sat, 05 Dec 2020 23:59:59 GMT
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At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. Position: Senior Clinical Trial Physician Cell Therapy Direct Manager: Executive Medical Director Division: Clinical R & D Management Location: Seattle, WA At Bristol Myers Squibb, we are inspired by a single vision transforming patinets lives through science. In oncology, hematology, immunology and cardiovascular disease and one f the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. Our Senior Clinical Trial Physician in Cell Therapy sits within Clinical Development, which is a global organization dedicated to the effective design and execution of the most innovativedrug development. Clinical Development drives clinical development strategy, design, execution, and interpretation of clinical trials. Position Summary / Objective – Serves as a primary source of medical accountability and oversight for 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 Position Responsibilities Medical Monitoring – Contributes to and is a key member of a high performing Study Delivery Team (SDT) and may be a member of the Clinical Development Team (CDT) – Conducts 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 – Collaborates 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 Clinical Development Expertise & Strategy – In collaboration with the Clinical Development Lead, designs and develops clinical plans and protocols with a strong strategic focus based on knowledge of asset/drug, disease area and relevant science in order 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 working with Clinical Scientists – 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.) – Identifies and builds relationships with principal investigators. Identifies and cultivates thought leaders in order to gain their inputs on emerging science in drug and biomarker research, disease knowledge, and design of clinical development studies and programs – 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 – 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 – Provides ongoing medical education in partnership with CS to allow for protocol-specific training, supporting the study team, investigators, and others Health Authority Interactions & Publications – Contributes to key Health Authority interactions and advisory board meetings as Clinical Trial Physician – 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 Degree Requirements – MD required (or x-US equivalent) Experience Requirements – 5 or more years of Industry experience and/or clinical trials experience is required – Prior cell therapy experience is a plus but not required Key Competency Requirements – Ability to communicate and present information clearly in scientific and clinical settings – Subspecialty training in applicable therapeutic area desired (eg adult or pediatric oncology or hematology) – 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 Travel Required Domestic and International travel will be required. Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. 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.