Bristol-Myers Squibb Company

Clinical Trial Lead

Location
Princeton, NJ, US
Posted
Oct 24, 2018
Ref
R1506823
Required Education
Doctorate/PHD/MD
Position Type
Full time
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

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
  • 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