Senior Manager, Cell Therapy Network Lead Investigator

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 to close complex trend investigations, participate in strategic discussions, anticipate bottlenecks and technical risks, and address issues proactively while fostering teamwork. The role involves collaborating 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 project.

Qualifications

• Required: 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.
• Preferred: Green Belt or Black Belt.
• 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.