Bristol Myers Squibb Clinical Trial Lead - Oncology in Princeton, New Jersey

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 based in the Princeton, NJ area.

JOB REQUIREMENTS

· 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

· 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

· Addresses relevant clinical queries from study sites; contributes to responses regarding study related HA and IRB questions

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled