Summit Therapeutics, Inc.

Program Manager

• Partners with Regulatory Affairs leadership and senior stakeholders to translate regulatory strategy and portfolio priorities into integrated execution plans
• Leads planning and execution of complex, high-visibility regulatory programs across functions, regions, indications, and products
• Chairs efficient, action-oriented team meetings to coordinate operations, decisions, and communications
• Integrates cross-functional workstreams across Research, Development, Regulatory Affairs, Manufacturing, and Medical Writing
• Defines and oversees major milestones, critical paths, decision points, objectives, and inflection points across regulatory programs
• Leads scenario planning and decision frameworks to support timely executive decision-making
• Works with subject-matter experts to develop timelines for key Regulatory Affairs deliverables supporting MAA/BLA, health-authority interactions, and regulatory filings
• Identifies, manages, and communicates program risks, opportunities, mitigation strategies, and required interventions
• Provides senior leadership with timely, accurate, and actionable visibility into program status, risks, decisions, and priorities
• Presents insights, recommendations, and program updates to C-suite and senior leadership audiences
• Ensures consistent application of program management standards, dashboards, governance models, and integrated regulatory filing timelines
• Supports continuous improvement of regulatory program management processes, tools, and operating models
• Leads strategic initiatives to mature the Program Management function as the company grows
• Mentors and develops Program Managers and strengthens organizational capability
• Reports to the VP or Senior Director of Program Management and may have people leadership responsibilities

Director, Regulatory Program Management