Clinical Trial Lead, Lung Program, Oncology Clinical Development

Bristol-Myers Squibb Lawrence Township, NJ

About the Job

Description:

Clinical Trial Lead, Oncology Clinical Development
ROLE IMPERATIVES
 • 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. • Contributes to DSURs and PSURs • Supports generation and coordination of clinical documents and deliverables in support of regulatory filings • Data review and cleaning of ongoing studies • Addresses relevant clinical queries from study sites and authors responses to study related IRB and HA questions
ESSENTIAL LEADERSHIP BEHAVIORS\:
 Establishes the Strategy • 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)
Qualification:
DESIRED BACKGROUND, KNOWLEDGE, AND EXPERIENCE\:
 • MD preferably with a back ground in clinical oncology; PhD with a deep understanding of the clinical oncology of the area of interest or equivalent therapy area knowledge • Has a deep understanding of the fundamentals of protocol development and follow up, including but not limited to \: o Study monitoring, data collection and analysis, database cleaning and database lock • Can work consistently in a matrix environment with relevant teams such as Clinical Operations, GBS, Global Safety, etc. • Can handle multiple, complex, studies in parallel • Has a history of prior meaningful participation in regulatory submissions • Has a history of strong interaction with thought leaders • Exhibits capable team leadership • 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