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. 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 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 improvement; acts as a change champion and effectively leads change
• Other key assignments including ad hoc and stretch assignments in support of Clinical Operations and clinical trial execution
• Travel on assignment 25%

Experience Education and Specialized Knowledge and Skills:

• University degree (e.g. BA BS or equivalent) required; preferably in life science; a clinical or advanced degree in a science health related or industry related discipline is preferred
• 12 years of strong experience with a pharmaceutical company and/or CRO with increasing levels of responsibility in Clinical Operations in a global environment (including directing platform support teams and key clinical systems such as TMF CTMS) preferred
• Experience in managing/leading others is also a requirement of the role
• Proven line and functional manager experience able to effectively lead teams including regional (multi-country) and remote-based staff
• Experience in Phase III execution of clinical trials in Oncology preferred
• Previous regulatory inspection experience preferred
• Comprehensive and current regulatory knowledge including ICH Good Clinical Practice regulations and guidelines
• Solid vendor oversight experience including contracts and budget management preferred

The pay range for this role is $190000-$237000 annually. 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 at to obtain prior written authorization before referring any candidates to Summit.