Clinical Trial Lead, Renal Cell Cancer Program, Oncology Clinical Development

Bristol-Myers Squibb Lawrence Township, NJ

About the Job


JOB DESCRIPTION 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




                ROLE IMPERATIVES

  • 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