Director, Clinical Operations (TMF)

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. Summit’s 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.

Summit’s team is inspired to touch and help change lives through Summit’s 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 China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.

Overview of Role:

The Director, Clinical Operations (TMF) is a clinical research drug development expert accountable for leading and optimizing the delivery of our next generation, integrated platform for clinical trial operations and document management systems including the people, process, technology that support these functions.

The individual leads transformative initiatives that create effective and efficient processes that meet high compliance standards; collaborating across Development (focus on Clinical Operations); serving as a change manager to implement new systems and practices that support the organization as we continue to grow.

The individual is an effective clinical operations team leader accountable for talent acquisition, development, management, and evaluation of team members in his/her/their group. This includes responsibility for the ‘What’ (delivery to performance goals) and the ‘How’ (deliver consistent with Summit Therapeutics core values).

The individual is also a member of the Clinical Operations extended leadership team and as such supports and influences the direction of the Clinical Operations extended team. The individual collaborates with team members to reinforce and operationalize strategic direction and solutions that support the ability to deliver on commitments to the organization and to patients.

This position reports to a VP, Head of Clinical Operations.

Role and Responsibilities:

• Develop, implement, and oversee the CTMS and TMF systems and related processes
• Oversee TMF and CTMS vendors, contractors, and cross-functional teams
• Manage and develop existing TMF employees and lead by example by demonstrating our core values
• Develop, implement, and communicate the strategic vision for TMF and CTMS to maximize end user focus and engagement
• Partner with key internal and external stakeholders to remediate risks and manage emerging issues.
• Develop proactive approaches to process improvements and enhancements of TMF and CTMS capabilities and standards
• Provide business level leadership, foster best practices, and mentor and consult on TMF and CTMS across the Development and Operations organizations
• Lead a team of TMF and CTMs colleagues and ensure their continuous development
• Develop and maintain effective working relationships with stakeholder functions to achieve Clinical Operations goals
• Keep current on changes in industry and regulatory standards for GCP requirements and advises on business impact for TMF and CTMS
• Participate as an active member of the Clinical Operations Extended Leadership Team (XLT)
• Ensure inspection ready TMF and CTMS and provide expert support for audits and inspections
• Instill a culture of continuous impr