Clinical Trial Physician - Cellular Therapy-

Company: Bristol Myers Squibb
Location: Jersey City
Posted on: January 12, 2021

Job Description:

At Bristol Myers Squibb, we are inspired by a single vision --- transforming patients--- lives through science. In 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.Functional Area DescriptionThe 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.Position Summary / ObjectiveServes as a primary source of medical accountability and oversight for clinical trialsMatrix management responsibilities across the internal and external networkManages Phase 1 --- Phase 3 studies, with demonstrated decision making capabilitiesProvides medical and scientific expertise to cross-functional BMS colleaguesPosition ResponsibilitiesMedical MonitoringContributes 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 reviewHolds 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 narrativesCollaborates 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 trainingClinical Development Expertise & StrategyIn 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 targetsProvides oversight and medical accountability for a group of studiesLeads the analysis of benefit/risk for clinical development protocols in a matrix team environment working with Clinical ScientistsPartners 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 programsMaintains 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 literatureKeeps abreast of development and regulatory issues related to other competitive or relevant compounds in development and how our portfolio fits into the competitive landscapeProvides ongoing medical education in partnership with CS to allow for protocol-specific training, supporting the study team, investigators, and othersHealth Authority Interactions & PublicationsContributes to key Health Authority interactions and advisory board meetings as Clinical Trial PhysicianAuthors/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 ScientistsDegree RequirementsMD required (or x-US equivalent)Experience Requirements3 or more years of Industry experience and/or clinical trials experience is requiredRegulatory filing experience preferredKey Competency RequirementsAbility to communicate and present information clearly in scientific and clinical settingsSubspecialty training in applicable therapeutic area desiredExpertise in the scientific method to test hypotheses, including statistical design, analysis, and interpretationKnowledge of drug development processKnowledge of the components needed to execute an effective clinical plan and protocolsStrong leadership skills with proven ability to lead and work effectively in a team environmentTravel RequiredDomestic and International travel may 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.Full time

Keywords: Bristol Myers Squibb, Jersey City , Clinical Trial Physician - Cellular Therapy-, Other , Jersey City, New Jersey