Job was saved successfully.
Job was removed from Saved Jobs.

Job Details


Bristol Myers Squibb

Cell Therapy Clinical Scientist

Science and Research

Scientist

No

Summit, New Jersey, United States

Bei Bristol Myers Squibb lassen wir uns von einer einzigen Vision inspirieren - die Veränderung des Lebens von Patienten durch Wissenschaft. In den Bereichen Onkologie, Hämatologie, Immunologie und Herz-Kreislauf-Erkrankungen - und eine der vielfältigsten und vielversprechendsten Pipelines der Branche - trägt jeder unserer leidenschaftlichen Kollegen zu Innovationen bei, die bedeutende Veränderungen vorantreiben. Wir verleihen jeder Therapie, für die wir Pionierarbeit leisten, eine menschliche Note. Kommen Sie zu Bristol Myers Squibb und machen Sie einen Unterschied.

Functional Area Description

The Clinical Scientist function 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.

Wir setzen uns auf der ganzen Welt leidenschaftlich dafür ein, das Leben von Patienten mit schweren Krankheiten zu beeinflussen. Unsere gemeinsamen Werte Leidenschaft, Innovation, Dringlichkeit, Verantwortlichkeit, Inklusion und Integrität befähigen uns, unsere individuellen Talente und unterschiedlichen Perspektiven in einer integrativen Kultur einzusetzen und bringen das höchste Potenzial jedes unserer Kollegen hervor.

Bristol Myers Squibb weiß um die Bedeutung von Balance und Flexibilität im Arbeitsumfeld. Wir bieten daher eine Vielzahl von attraktiven Benefits, Dienstleistungen und Programmen an, die unseren Mitarbeitern die Ressourcen bieten, ihre Ziele sowohl bei der Arbeit als auch in ihrem Privatleben zu verfolgen.