Clinical Trial Lead

Bristol-Myers Squibb Lawrence Township, NJ

About the Job

Description:

 

 

 

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

Qualification:

JOB REQUIREMENTS

                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

 

 

 

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

  • 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)

 

DESIRED BACKGROUND, KNOWLEDGE, AND EXPERIENCE

  • 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