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Clinical Scientist Team Lead - Cell Therapy

Company: Celgene
Location: Jersey City
Posted on: June 4, 2021

Job Description:

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.Functional Area DescriptionThe Clinical Scientist Team Lead reports through the Clinical Science function which provides scientific expertise necessary to design and deliver clinical studies and programs.Position Summary / ObjectiveLeads the Clinical Science team in the planning and execution of clinical trial activities to support the Clinical Development Plan for the disease/indication teamManages and supervises a team of senior and junior Clinical Scientists to execute trial level activities for multiple trialsEnsures consistency across studies and provide oversight of all clinical studies within assigned areaMay serve as a Clinical Trial Lead or Co-Lead as neededMay represent the Clinical Scientist function in various process improvement initiatives and/or cross functional activitiesServes as a key cross functional collaborator; initial point of escalation cross functionsPosition ResponsibilitiesCollaborate with Program Lead Scientist and Clinical Development Lead to support development of clinical development and lifecycle planningLead implementation of assigned clinical development and/or lifecycle plansMaintain an advanced understanding of all protocols within assigned ProgramProvide scientific and clinical leadership to support all activities to advance the assigned plans; Provide program/study/therapeutic area/skills training to team membersRepresent Clinical Scientist Team on the Development Team as appropriate/requestedSupport resourcing and budget planning activities for teamReview and present data and information to external investigators and internal stakeholders as neededIdentify and liaise with internal and external collaborators independently and oversee collaboration between clinical scientist and external partners for scientific adviceLead proactive risk identification and mitigation at indication level; provide progress reports and risk assessment updates to Sr. ManagementAuthor/Review abstracts/publicationsOversee, contribute to, and ensure quality execution of deliverables for all phases of assigned trials (start up/conduct/closure), through activities such as:Evaluation of innovative trial designsProtocol and ICF developmentSite-facing activitiesCRA training materialsData quality activities; ensure consistent, quality data review across trial teamsInvestigator Meetings, SIVs, Advisory Board, and Study committee (e.g., DMC) activitiesClinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses)Degree RequirementsDegree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred)Experience Requirements5+ years of experience in clinical science, clinical research, or equivalentExperience in driving, managing and collaborating in a team/matrix work environmentRecognized internally and externally as a Therapeutic Area and Functional expertKey Competency RequirementsAdvanced knowledge of GCP/ICH, drug development process, study design, statistics, clinical operationsAbility to plan and manageAdvanced ability to analyze, interpret, and present dataAdvanced knowledge and skills to support program specific data review, trend identification, data interpretationAdvanced knowledge of indication, therapeutic area, compound(s), competitive landscape and health authority requirementsAdvanced medical writing and presentation skillsAbility to self-supervise, and act independently to identify/resolve program level issuesProficient critical thinking, problem solving, decision making skillsEffective planning and time managementAdvanced verbal, written and interpersonal skills (communication skills)Adaptable and analyticalStrong presentation skills / leadership presenceCommitment to QualityAdaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalismProficient planning/project management skills (ability to develop short to mid-range plans that are realistic and effective in meeting goals)Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J-Review or similar data reporting toolsTravel RequiredDomestic and International travel may be required.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 the resources to pursue their goals, both at work and in their personal lives.

Keywords: Celgene, Jersey City , Clinical Scientist Team Lead - Cell Therapy, Other , Jersey City, New Jersey

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