Manager II, Program Management - Late-Stage Development

Role: Lead program management for late-stage (Phase 2b/3) drug development programs, focusing on strategy, planning, and execution through regulatory submission and launch. Responsibilities: develop integrated cross-functional plans, manage timelines across clinical, regulatory, CMC, quality, medical affairs, and commercial teams; oversee pivotal trial coordination, regulatory filings, risk management, and contingency planning; facilitate governance meetings and stakeholder communications; support budget and resource planning; and serve as a program management expert within the organization. Requirements: minimum 8+ years of biotech/pharma product development experience, with at least 5+ years in project or program management; proven track record managing programs from preclinical through Phase 3, including regulatory submission support; bachelor’s degree in a life sciences or related field, advanced degrees a plus; strong knowledge of GxP, ICH guidelines, and health authority interactions; proficiency in project management tools; excellent leadership, communication, and stakeholder management skills. HighValue: late-stage drug development, Phase 2b/3, regulatory submission, cross-functional coordination, risk management, and launch planning. WorkSetup: hybrid Irvine; travel up to 10%.