Manager II, Program Management - Late-Stage Development

Irvine, California, United States

Hi Tarsan!

Thanks for your interest in this position. Please review the details and if role and if it's something that could match your career goals, connect with your current manager and HRBP to discuss if your experience and skills line up. If everything is a go, please apply and the Talent Acquisition team will contact you for an interview so we can also get to know you better.

- Your Human Resources Team

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.

• 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
• Drive integrated regulatory submission planning and execution (e.g., NDA/BLA/MAA) in close partnership with Regulatory Affairs, ensuring alignment of cross-functional deliverables to support on-time, high-quality filings
• Support launch readiness planning by coordinating cross-functionally across clinical development, regulatory, medical affairs, commercial, and supply chain/manufacturing
• Identify and assess program risks; develop, track, and drive mitigation and contingency plans, including maintenance of a program risk register
• Lead scenario planning efforts to prepare teams for differing outcomes at key milestones (e.g., pivotal readouts, regulatory interactions, launch)
• Challenge assumptions and provide recommendations to improve program processes, decision-making, and outcomes
• Facilitate and document Development Core Team and sub-team meetings, cross-functional communications, and governance decisions, ensuring alignment with internal functional groups and leadership
• Support program budget and resource planning in partnership with Finance and functional leads, tracking spend against forecast and flagging variances
• Develop strong relationships with key functional stakeholders and their leadership across the organization to support execution of program goals
• Serve as a Program Management subject matter expert and resource for the broader organization, championing program management best practices and continuous improvement

• Minimum 8+ years of product development experience in biotech or pharmaceutical settings, including at least 5+ years in a project/program management role
• Experience managing drug development programs from pre-clinical through Phase III studies is essential; direct experience supporting a program through pivotal trials, regulatory submission, and launch readiness is strongly preferred
• Bachelor’s degree in a biopharmaceutical-related field (e.g., biology, chemistry, engineering) required; advanced degree a plus
• Working knowledge of the end-to-end drug development process,…