Senior Director, Clinical Operations (TMF & CTMS)

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Senior Director, Clinical Operations (TMF & CTMS)

Location : On-site 4 days per week at our Menlo Park, CA, Princeton, NJ or Miami, FL office.

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 (e.g., 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 Summit’s 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 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.

Role and 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 (~25%)
• All other duties as assigned

Experience, Education and Specialized Knowledge and Skills :

The pay range for this role is $230,000-$250,000 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 Summit’s Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.

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