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Bristol Myers Squibb
Princeton, NJ, United States
30+ days ago
Bristol Myers Squibb
Redwood City, CA, United States
30+ days ago
Genmab
Plainsboro, NJ, United States
30+ days ago
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Plainsboro, NJ, United States
30+ days ago
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Plainsboro, NJ, United States
30+ days ago
Genmab
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30+ days ago
Genmab
Plainsboro, NJ, United States
30+ days ago
Bristol Myers Squibb
Princeton, New Jersey, United States
30+ days ago

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 Early Development Clinical Scientist function provides scientific expertise necessary to design and deliver clinical studies and programs.

Position Summary/Objective:

  • Responsible for design and execution of assigned clinical trial activities and works closely with clinical team members to execute activities associated with trial conduct.

  • May lead or support trial level activities for one or more trials with the necessary supervision.

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.

  • Collaborate cross-functionally to develop Protocol and ICF documents / amendments and present these to governance committee and early clinical development team meetings as required.

  • Conduct literature review.

  • Develop site and CRA training materials and present these at SIVs and Investigator meetings.

  • Review clinical narratives.

  • Collaborate cross-functionally to monitor clinical data for specific trends.

  • Contribute to the development of 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.

  • Author/review clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., Pre-IND, IND, IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission.)

  • Submit clinical documents to TMF.

Degree Requirements:

  • Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field preferred).

Experience Requirements:

  • Expectation of 2+ years of experience in clinical science, clinical research, or equivalent, hematology and oncology prior experience preferred.

  • Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations.

  • Ability to understand assigned protocol(s) and their requirements.

  • Knowledge and skills to support program-specific data review and trend identification.

  • Intermediate medical writing skills and medical terminology.

  • Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees.

Key Competency Requirements:

  • Basic planning/project management skills (develop short range plans that are realistic and effective)

  • Basic knowledge of disease area, compound, current clinical landscape.

  • Detail-oriented with commitment to quality

  • 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., patient profiles, report generating tools)

  • Domestic and international travel may be required (approximately 10-20%)



Job Information

  • Job ID: 59611312
  • Location:
    Princeton, New Jersey, United States
    Cambridge, Massachusetts, United States
    San Diego, California, United States
    San Francisco, California, United States
    Seattle, Washington, United States
    Summit, New Jersey, United States
  • Position Title: Clinical Scientist, Early Clinical Development (Hematology, Oncology & Cell Therapy)
  • Company Name: Bristol Myers Squibb
  • Job Function: Clinician/Practicing Oncologist
  • Work Setting: Industry/Biotech
  • Job Type: Full-Time

Please refer to the company's website or job descriptions to learn more about them.

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