Manager II, Program Management - Late-Stage Development
MiddleOn-site (Irvine)Salary undisclosed
Job Description
About the Role
Join us in advancing our pipeline to address a number of diseases across therapeutic categories, including eye care and other conditions with high unmet need.
This role will lead program management for a late-stage (Phase 2b/3 through regulatory submission, approval, and launch readiness) drug development program. The Manager II, Program Management partners closely with the Program Team Lead and Development Core Team to drive cross-functional program strategy, integrated development planning, and disciplined execution through pivotal trial readouts, regulatory filing, approval, and commercialization.
Let’s talk about some of the key responsibilities of the role:
- Partner with the Program Team Lead and Development Core Team to develop and execute cross-functional program strategy and integrated development plans for a late-stage program
- Establish and maintain functionally integrated program timelines spanning clinical, regulatory, CMC/manufacturing, quality, nonclinical, medical affairs, and commercial activities to enable accurate program analyses, identify critical path activities, and surface resource constraints
- Lead cross-functional planning and coordination for pivotal (Phase 3) trial execution, database lock, and topline readout activities
- Dr
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