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Clinical Scientist - Cell Therapy

Company: Bristol Myers Squibb
Location: Princeton
Posted on: November 23, 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.The Clinical Scientist function provides scientific expertise necessary to design and deliver clinical studies and programs.Position SummaryWill be responsible for design and execution of assigned clinical trial activities and work closely with clinical team members within the assigned project to execute activities associated with the conductMay serve as Clinical Trial Lead for one or more trialsMay lead or support trial level activities for one or more trials with the necessary supervisionMay co-lead study team meetings in partnership with GDO protocol manager and collaborate with cross-functional study team membersPosition ResponsibilitiesCollaborate and liaise with external partners (e.g., KOLs)Seek out and enact best practices with instructionProvide regular and timely updates to manager/management as requestedDevelop Protocol and ICF documents / amendments and present these to governance committee and development team meetings as requiredConduct literature reviewSubmit clinical documents to TMFDevelop site and CRA training materials and present these at SIVs and Investigator meetingsReview clinical narrativesMonitor clinical data for specific trendsDevelop Data Review Plan in collaboration with Data ManagementEnsure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/ProgrammingSubmit clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission.)Degree RequirementsDegree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred). Appropriate for new entrance to pharma (post fellowship/ new to industry)Experience RequirementsBasic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operationsAbility to understand assigned protocol(s) and their requirementsBasic knowledge skills to support program-specific data review and trend identificationIntermediate medical writing skills and medical terminologyBasic planning/project management skills (develop short range plans that are realistic and effective)Key Competency RequirementsDetail-oriented with commitment to qualityBasic knowledge of disease area, compound, current clinical landscapeBasic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committeesIntermediate critical thinking and problem-solving skillsAdaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)Intermediate skills in Microsoft Word/Excel/PowerPoint and data review tools (e.g., Pt Profiles, report generating tools)Travel 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 Jobble

Keywords: Bristol Myers Squibb, Trenton , Clinical Scientist - Cell Therapy, Healthcare , Princeton, New Jersey

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