Manager II, Program Management - Late-Stage Development
TarsusRX•Irvine, CA
•Hybrid
About The Position
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
Benefits
- health, dental and vision insurance benefits
- generous paid time off, including vacation, holidays, and personal days
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What This Job Offers
Job Type
Full-time
Career Level
Manager
