Principal Clinical Scientist (Director)

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.

Summary

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. 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.

Overview

This position serves a key role in the effective implementation of a Global Clinical Development strategy. As such, the Principle Clinical Research Scientist (PCRS) will lead or co-lead one or more clinical trials within a clinical program. This includes program implementation, including oversight of all aspects of clinical study development, start up, conduct, and close out. The PCRS works closely within the clinical function as well as cross-functionally and with external stakeholders to provide high quality and timely deliverables.

Responsibilities

  • Successfully plans execution of deliverables and anticipates future work
  • Partner with the Team Lead CRS and Clinical Research Physician (CRP) to lead the implementation of the global Clinical Development Plans as assigned. This includes leading activities for one or more complex clinical studies with a high level of independence including all study start-up/conduct/close-out activities
    • Author and/or provide meaningful review of high quality protocols, informed consent forms, Clinical Study Report, charters, meeting minutes and presentation materials
    • Author and/or review Regulatory Documents (e.g., Investigator Brochure, Briefing Books, NDA submissions) and responses to Health Authority and IRB questions
    • Prepare and facilitate high quality site and CRA training, including author/review materials
    • Partner with functions to conduct country/site selection activities and facilitate clinical decision on countries/sites
    • Collaboration with Clinical Operations to ensure study plans are comprehensive and in alignment to meet study objectives; provide high quality information to support budget preparation, CRO scope of work development, other specifications
    • Collaboration with other study team functions to prepare and review study related documents (e.g. lab manuals, drug labels, IVRS specifications, CRFs and programming specifications for data review tools, statistical analysis plans)
    • Investigator Meeting (IM) and SIV planning/facilitation/presentation; ensuring clear and effective protocol presentations are created
      • Clinical oversight of study data, specifically, the PCRS is responsible to:
      • partner with the Program Lead CRS and CRP to provide leadership to the study CRS team and ensure an understanding of the interdependencies of CRFs, agreed upon data conventions/ rules, IRT specifications and use efficient data review tools.
      • collaborate with DM to plan and achieve milestones and database lock
      • conduct clinical data review and communicate with Field Monitors and sites when necessary to resolve data queries
      • partner with Clinical Research Physician in data review - generation of reports, action plans, trend identification, etc)
      • collaborate with study team members (Clinical, Clinical Operations, Data Management, Statistics, Drug Safety, IMSC, Regulatory Affairs, Translational Medicine and Project Management) to ensure that key milestones are met on time and with high quality
      • completes advanced tasks independently of the CRP (medical oversight remains with CRP)
      • oversee tasks of CRSs assigned to study/studies as requested, and may mange contractor(s)
      • regularly attend and actively participate and demonstrate clinical leadership in study team meetings and other cross-functional meetings as warranted (e.g., SMT), and lead clinical meetings
      • provide guidance and scientific expertise within team, across department, and across functions
      • independently lead planning and prepare information for external /stakeholder meetings (e.g., IMs, Advisory Boards, Governance, Regulatory Authority)
      • present data/information to external investigators or study staff (e.g., SIV presentations)
      • identify and liaise with external partners with minimal guidance
      • identify and independently resolve most current/potential issues; escalate appropriately
      • Support or lead process improvement and departmental trainings activities
      • Serve as peer coach or mentor; provide guidance to junior members of the team
      • Support program level and TA level activities as needed

Skills/Knowledge Required

  • Ability to assimilate technical information quickly
  • Advanced critical thinking, problem solving, decision making skills
  • Advanced planning/management skills
  • Advanced knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees.
  • Proficiency in leading teams and activities
  • Advanced skills in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J-Review or similar data reporting tools

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.

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