Director, Regulatory Program Management

About Summit:

Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life increasing potential duration of life and resolving serious unmet medical needs. At Summit we believe in building a team of world class professionals who are passionate about this mission and it is our people who drive this mission to reality. Summits core values include integrity passion for excellence purposeful urgency collaboration and our commitment to people. Our employees are truly the heart and soul of our culture and they are invaluable in shaping our journey toward excellence.

Summits team is inspired to touch and help change lives through Summits clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies including:

Non-small Cell Lung Cancer (NSCLC)

• HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.

• HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.

• HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.

Colorectal Cancer (CRC)

• HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.

Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than Chinas National Medical Products Administration (NMPA). Summit is headquartered in Miami Florida and has additional offices in California New Jersey the UK and Ireland.

Overview

The Director Regulatory Program Management (RPM) provides strategic and operational leadership for high-priority complex regulatory filings and submissions across the product portfolio. This role drives alignment across Research Development Regulatory Affairs Manufacturing and execution teams to ensure regulatory objectives are delivered with clarity rigor and accountability.

The Director partners closely with Regulatory Affairs Medical Writing Program Leadership and cross-functional development teams to translate portfolio and regulatory strategies into executable plans. The role serves as a key contact for executive leadership and supports disciplined governance and strengthens the Program Management function as the organization scales.

In addition this leader contributes to developing the operating model for regulatory project management advances portfolio-level visibility and builds organizational capability to support complex submissions health-authority interactions and other critical regulatory initiatives. This position reports to the VP or Sr. Dir Program Management and may have people leadership responsibilities.

Role and Responsibilities

• 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 Medical Writing as appropriate.
• 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 SMEs to develop timelines for key RA deliverables to support MAA/BLA HA interactions and regulatory filings and ensures deliverables are on track.
• 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. Present clear 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 aligned with enterprise goals.
• 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 strengthen organizational capability.

Experience Education and Specialized Knowledge

• Bachelors 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 (e.g. MS Office Project Smartsheet)
• Willing to travel for key meetings.

Actual compensation packages are based on several factors that are unique to each candidate including but not limited to skill set depth of experience certifications and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus stock benefits and/or other applicable variable compensation.

Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summits Talent Acquisition team atto obtain prior written authorization before referring any candidates to Summit.

Summit Therapeutics an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment hiring training or promotion or any other employment practices for reasons of race color religion gender national origin age sexual orientation marital or veteran status disability or any other legally protected status.