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Job Details


Bristol Myers Squibb

Clinical Scientist - Cell Therapy (R1558770-fr-fr-1)

Science and Research

Scientist

Yearly

No

Summit, New Jersey, United States

Chez Bristol Myers Squibb, nous sommes inspirés par une vision unique : transformer la vie des patients grâce à la science. Dans les domaines de l'oncologie, de l'hématologie, de l'immunologie et des maladies cardiovasculaires – avec l'un des pipelines les plus diversifiés et les plus prometteurs de l'industrie - chacun de nos collègues est passionné et contribue à des innovations qui entraînent des changements significatifs. Nous apportons une touche humaine à chaque traitement dont nous sommes les pionniers. Rejoignez-nous et faites une difference!

Functional Area Description

The Clinical Scientist function in Cell Therapy provides scientific expertise necessary to design and deliver clinical studies and programs.

Position Summary / Objective

  • Will 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 conduct
  • May serve as Clinical Trial Lead for one or more trials
  • May lead or support trial level activities for one or more trials with the necessary supervision
  • May co-lead study team meetings in partnership with GDO protocol manager and collaborate with cross-functional study team members

Position Responsibilities

  • Collaborate and liaise with external partners (e.g., KOLs)
  • Seek out and enact best practices with instruction
  • Provide regular and timely updates to manager/management as requested
  • Develop Protocol and ICF documents / amendments and present these to governance committee and development team meetings as required
  • Conduct literature review
  • Submit clinical documents to TMF
  • Develop site and CRA training materials and present these at SIVs and Investigator meetings
  • Review clinical narratives
  • Monitor clinical data for specific trends
  • Develop Data Review Plan in collaboration with Data Management
  • Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming
  • Submit 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 Requirements

  • Degree 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 Requirements

  • Basic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
  • Ability to understand assigned protocol(s) and their requirements
  • Basic knowledge skills to support program-specific data review and trend identification
  • Intermediate medical writing skills and medical terminology
  • Basic planning/project management skills (develop short range plans that are realistic and effective)

Key Competency Requirements

  • Detail-oriented with commitment to quality
  • Basic knowledge of disease area, compound, current clinical landscape
  • Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
  • Intermediate critical thinking and problem-solving skills
  • Adaptable / 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 Required

Domestic and International travel may be required.

Partout dans le monde, nous sommes passionnés par le fait d'avoir un impact sur la vie des patients atteints de maladies graves. Habitués à appliquer nos talents individuels et nos diverses perspectives dans une culture inclusive, nos valeurs communes de Passion, d'Innovation, d'Urgence, de Responsabilité, d'Inclusion et d'Intégrité font ressortir le potentiel de chacun de nos collègues.

Bristol Myers Squibb reconnaît l'importance de l'équilibre et de la flexibilité dans notre environnement de travail. Nous offrons une grande variété d'avantages, de services et de programmes concurrentiels qui fournissent à nos employés les ressources nécessaires pour poursuivre leurs objectifs, tant au travail que dans leur vie personnelle.