Bristol Myers Squibb Clinical Trial Lead, Lung Program in Princeton, New Jersey
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.
** The Grade/Level of the Role Will be Determined by the Qualifications and Experience of the Chosen Candidate **
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.
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)
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
DESIRED BACKGROUND, KNOWLEDGE, AND EXPERIENCE
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
Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.