Manager II, Program Management - Late-Stage Development

Welcome to the Tarsanet Internal Career Center!•Irvine, CA

1d•$134,200 - $188,000•Hybrid

About The Position

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.

Requirements

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, including GxP/ICH guidelines and health authority interactions, for late-stage programs
Ability to quickly and effectively pivot in response to changing priorities across programs and resources
Proficient use of IT/project management tools (Outlook, Excel, PowerPoint, MS Project, Smartsheet, or similar)
Established track record of effective people management, problem solving, collaboration, cross-functional leadership, and communication
Excellent communication, influencing, stakeholder management, and decision-making skills
Strong project/program management foundation; PMP or PgMP certification preferred but not required
Excellent communication and emotional intelligence to lead cross-functional stakeholders in achieving deliverables on time and within budget, with a demonstrated ability to implement effective processes and innovative solutions that improve program management efficiency

Nice To Haves

Advanced degree a plus
PMP or PgMP certification preferred but not required

Responsibilities

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