Clinical Trial Lead, Oncology Clinical Development
Location:
Princeton , New Jersey
Posted:
November 16, 2016
Reference:
1604613
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)

Qualifications:
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 : 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
A little about us:
Our shared focus to become a Diversified Specialty BioPharma company is driving us forward. Pioneering in new areas of research.

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