Bristol-Myers Squibb Company

Clinical Trial Lead

Location
Princeton, NJ, United States
Posted
Sep 17, 2019
Ref
R1517666
Required Education
Doctorate/PHD/MD
Position Type
Full time
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

JOB DESCRIPTION
  • Work with the Program Lead and team members to translate the FDT strategy into trial options and protocols
  • Clinical monitoring of one or more studies
  • Medical Data Review (and data cleaning support as appropriate) of ongoing studies working with Clinical Operations and Data Management.
  • Addresses relevant clinical queries from study sites with documentation in eTMF
  • 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
  • Work consistently in a matrix environment
  • MD, 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
  • 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 trial options, protocols and action plans
  • Work with the Program leads to author clinical protocols and related documents (CRF, DRP), 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
  • New entrance to pharma: out of fellowship/ new to industry
  • Limited clinical research experience (substantial academic research experience could potentially substitute)
  • Relevant clinical research experience (relevant academic research experience could potentially substitute)
  • 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
  • Performs as an individual contributor
  • Identifies when an issue is present and begins to address


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.