Senior Manager, Cell Therapy Network Lead Investigator
Bristol Myers SquibbWant to see how your resume matches up to this job? A free trial of our JobsAI will help! With over 2,000 biopharma executives loving it, we think you will too! Try it now — JobsAI.
Role Summary
Senior Manager, Cell Therapy Network Lead Investigator will support the commercial and late stage clinical cell therapy network for complex trend investigations stemming from deviations and SAEs. The lead investigator will assemble and lead cross functional matrix teams necessary to close complex trend investigations. He/she will participate in strategic discussions, anticipate bottlenecks, technical risks, and address issues proactively, while fostering an environment of teamwork. The person will collaborate with SMEs, user groups, quality groups, and other stakeholders to complete complex trend deviations and CAPAs
Responsibilities
- Serve as lead investigator for global trend investigations and global SAE events.
- Support site based investigators for complex trend investigations.
- Manage complex cross-functional projects/programs using project management techniques and tools appropriate for the given project.
Qualifications
- Bachelor's degree or equivalent in relevant discipline with a minimum of 5 years of relevant experience. Masters preferred (but not required). Time spent in advanced degree programs may be considered as equivalent relevant experience
- Green Belt or Black belt is preferred but not required
- Expert understanding of cGMP regulations and/or business and documentation processes
- Expert in root cause analysis, CAPA and risk mitigation
- Proficient in project and portfolio management skills