Clinical Trial Lead, Breast Program, Oncology Clinical Development
- Employer
- Bristol Myers Squibb Company
- Location
- Princeton, NJ, United States
- Start date
- Jul 22, 2019
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- Discipline
- Clinical, Clinical Development, Clinical Trials
- Required Education
- Doctorate/PHD/MD
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
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
D07/D07M ROLE IMPERATIVES
• 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
D08/D08M ROLE IMPERATIVES
• D07 - D07M Job Requirements Plus:
• 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
D07/D07M 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
D08/D08M ESSENTIAL LEADERSHIP BEHAVIORS
• D07 - D07M Job Requirements Plus:
• 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)
D07/D07M 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
D08/D08M DESIRED BACKGROUND, KNOWLEDGE, AND EXPERIENCE
• D07 - D07M Job Requirements Plus:
• 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
Company
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.
At Bristol Myers Squibb, we believe in the power of science to address some of the most challenging diseases of our time. Our focus on these unmet needs comes during a remarkable time, when unprecedented scientific breakthroughs are advancing the treatment of disease as never before in human history.
We work every day to transform patients’ lives through science. Each day, our employees around the world work together for patients – they are at the center of everything we do. They inspire us. They are the reason we come to work each day.
We combine the agility of a biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation.
- Website
- http://www.bms.com/
- Phone
- +1-800-332-2056
- Location
-
430 E. 29th St
14th Floor
New York
New York
10016
United States
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