Senior Director, Clinical Operations (TMF)

Summit Therapeutics plc•Menlo Park, CA

33d•$230,000 - $250,000

About The Position

About Summit Ivonescimab also known as SMT112 is a novel potential first in class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD 1 with the anti angiogenesis effects associated with blocking VEGF into a single molecule Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD 1 and VEGF Summit has begun its clinical development of ivonescimab in non small cell lung cancer NSCLC with three active Phase III trials HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR mutated locally advanced or metastatic non squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI eg osimertinib HARMONi 3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first line metastatic NSCLC HARMONi 7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first line metastatic NSCLC whose tumors have high PD L1 expression Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summits license territories including the United States and Europe Ivonescimab was approved for marketing authorization in China in May 2024 Ivonescimab was granted Fast Track designation by the US Food & Drug Administration FDA for the HARMONi clinical trial setting Overview of Role The Senior 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 Senior Director Clinical Operations TMF is an effective clinical operations team leader accountable for talent acquisition development management and evaluation of team members in hishertheir 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

Requirements

Bachelors degree eg 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
Minimum of 12 years of strong experience with a pharmaceutical company andor 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
A minimum of 5 years of experience in people managementleadership required
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; Oncology trials preferred
Previous regulatory inspection experience preferred
Strong comprehensive and current regulatory knowledge including ICH Good Clinical Practice regulations and guidelines
Significant vendor oversight experience including contracts and budget management preferred

Responsibilities

Develop implement and oversee the CTMS and TMF systems and related processes
Lead the oversite of TMF and CTMS vendors contractors and cross functional teams provide leadership and development to existing TMF employees and lead by example by demonstrating our core values
Define eexecute 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
Provide strategic leadership insight and guidance 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 25All other duties as assigned