The Director will manage CMC planning activities, identifying gaps and implementing cross-functional strategies to support late-stage development and commercial regulatory submissions. They will lead project teams, maintain integrated project plans, and drive decision-making processes across technical operations.
The Senior Director will lead statistical strategy, analysis, and reporting for Phase 3 clinical trials while overseeing regulatory deliverables and cross-functional team collaboration. They are responsible for authoring statistical analysis plans and providing leadership for complex issues including randomized versus treated populations.
