Clinical Trial Lead, Pediatrics Program, Oncology Clinical Development

  • Company: Bristol-Myers Squibb
  • Location: Lawrence Township, New Jersey
  • Posted: February 03, 2017
  • Reference ID: 1700420
  • Work with the Program Lead or Senior Clinical Lead, and team members to translate the FDT strategy into protocols
  • Clinical monitoring of one or more studies
  • Data review and cleaning of ongoing studies
  • Addresses relevant clinical queries from study sites
  • Identify and builds relationships with investigators
  • Contributes to DSURs and PSURs
  • Supports generation and coordination of clinical documents and deliverables in support of regulatory filings
  • Can work consistently in a matrix environment
  • MD preferably with a background in clinical oncology; PhD, Pharm D or other health related scientific field with a deep understanding of the clinical oncology of the area of interest or equivalent therapy area knowledge.
  • 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

  • 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
  • Addresses relevant clinical queries from study sites; contributes to responses regarding study related HA and IRB questions
  • Work with the Program Lead, team members and governance bodies to translate the FDT strategy into protocols and action plans
  • Work with the Program leads to author clinical protocols and related documents, including Clinical study reports, clinical regulatory documents including integrated summaries and clinical overview .
  • Addresses relevant clinical queries from study sites; and authors responses to study related HA and IRB questions

  • 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
  • Identify and builds relationships with principal investigators
  • Identify Thought Leaders and use them for inputs in clinical strategy and protocol design
  • Maintain a strong medical/scientific reputation within the disease area
  • Contribute to Health Authority interactions as a Medical Monitor on assigned clinical studies
  • Share specific clinical strategies with other clinical teams
  • Study-specific clinical design and execution
  • Manage communication with key stakeholders (senior)

  • 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
  • Has a deep understanding of the fundamentals of protocol development and follow up, including but not limited to: Study monitoring, data collection and analysis, database cleaning and database lock
  • Has a history of handling multiple, complex, studies in parallel
  • Has a history of prior meaningful participation in regulatory submissions
  • Has a history of strong interaction with thought leaders
  • Proven team leadership capability

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