Director, Regulatory Program Management

🔥 5 minutes ago

🇺🇸 United States – Remote

💵 $190k - $237k / year

⏰ Full Time

🔴 Lead

📋 Program Manager

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Summit Therapeutics, Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2003

🏥 Healthcare

💼 Consulting

📣 Marketing

🔥 Funding within the last year

💰 $500M Post-IPO Equity - Summit Therapeutics on 2025-10

Healthcare • Consulting • Marketing

Summit Therapeutics, Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of novel medicinal therapies to improve quality and duration of life for patients with serious unmet medical needs. The company is advancing ivonescimab (SMT112), a novel bispecific antibody targeting PD-1 and VEGF, through multiple Phase 3 clinical trials for non-small cell lung cancer and other solid tumors under license from Akeso. Summit emphasizes clinical development, regulatory filing strategies, and potential commercialization in its licensed territories while promoting patient- and caregiver-friendly treatment options.

📋 Description

• 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

🎯 Requirements

• Bachelor’s degree and minimum 12 years of relevant regulatory project management/scientific experience within the pharmaceutical industry; OR a MS or MBA and minimal 10 years of relevant experience; OR a PhD in a scientific field or a PharmD, or DVM with 6+ years of relevant experience • Prior solid tumor oncology experience required • Significant experience leading complex, global, cross-functional regulatory programs • Demonstrated experience with major regulatory submissions and health-authority interactions • Experience operating effectively with senior and executive-level stakeholders and leading through influence in highly matrixed organizations • Strong understanding of pharmaceutical development and the regulatory submission lifecycle • Exceptional project-management, communication, facilitation, and organizational capabilities • Strong proficiency in program management and planning tools, including MS Office, Project, and Smartsheet • Willing to travel for key meetings

🏖️ Benefits

• Bonus, stock, benefits and/or other applicable variable compensation may be included in the total compensation package • Equal Opportunity Employer