Clinical Trial Lead, Non-Hodgkin's Lymphoma, Other Leukemia Program

Bristol-Myers Squibb Lawrence Township, NJ

About the Job

Description:

Role Imperatives

  • Work with Senior Clinical Lead/Program Lead to translate the FDT strategy into protocols
  • Responsible for the study timelines in a cross-functional matrix protocol team
  • Responsible for the clinical development activities from site(s) initiation to study discontinuation
  • Ensure that all the activities around study implementation are compliant with the GCP and regulatory requirements
  • In collaboration with GRS and GPV&E, designs and implements safety monitoring plans
  • Interprets clinical data and makes appropriate decisions and recommendations to the Program Working Team sub team
  • Contributes to DSURs and PSURs
  • Supports generation and coordination of clinical documents and deliverables in support of regulatory filings
  • Clinical monitoring of one or more studies
  • Support data review and cleaning of ongoing studies
  • Addresses relevant clinical queries from study sites; contributes to responses regarding study related HA and IRB questions

Essential Leadership behaviors

  • Identify and builds relationships with study investigators
  • Is seen and acts as the study expert by the site personnel
  • Ability to work and communicate efficiently with internal partners in the US for positions located outside the US
  • Working effectively in a matrix organization
  • Share specific clinical strategies with other clinical teams and regions

 

Qualification:

DESIRED BACKGROUND, KNOWLEDGE, AND EXPERIENCE

  • MD preferably with a background in clinical oncology; PhD with a deep understanding of the clinical oncology of the area of interest or equivalent therapy area knowledge
  • Understanding of the fundamentals of clinical development (e.g. from working as an investigator, working in an adjacent group in industry - e.g. monitoring)
  • Management of one or more uncomplicated studies and preparation of regulatory documents;
  • Can work consistently in a matrix environment
  • The position is preferably based in the Princeton, NJ area but may be based in another R&D site or selected BMS subsidiary depending on business needs