**Position requires qualified candidates to be based in one of the following locations within the US**: Southwest / Texas / Northwest / Central 

About Summit:

Ivonescimab, 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 Manager/Associate Director, Clinical Operations Site Partner (CSP), is accountable for providing leadership and operational expertise into execution of one or more phase 1-3 clinical trials conducted in a specific US region. The role will be part of the Global Clinical Operations (GCO) group reporting into USA Senior Director, Clinical Operations. This position is expected to address historic operational challenges in conducting clinical studies: 

• Slow start-up timelines 

• Site recruitment challenges 

• Role designed to drive clinical trial strategy and execution while becoming industry leader 

• Augment ClinOps study team (both Summit and CRO) activities to support study execution, including addressing any quality issues 

• Development strategies to drive concierge level support for sites to ensure Summit journey to be Sponsor of Choice 

Role and Responsibilities: 

• Recommend oncology sites based on indication, community clinics requirements, etc. 

• Engage investigators early on for feedback on protocol, design, recruitment rate, local practices, etc. 

• Assist with feasibility questionnaire support (as needed) 

• Maximize start-up efficiencies and expedite activation 

• In-depth knowledge of site capabilities, and processes 

• Attend SIVs and IMs as possible 

• Provide concierge level support 

• Motivate sites?& identify obstacles quickly for resolution for recruitment challenges 

• Tracking of key site performance metrics 

• All other duties as assigned 

Experience, Education and Specialized Knowledge and Skills: 

• BA/BS required; in a scientific/medical field preferred 

• Previous CRA experience and / or regional manager in a CRO highly desirable 

• A minimum of 8+ years industry or related experience 

• Extensive late-stage drug development oncology experience is required 

• Knowledge and experience of drug development in US 

• Ability to travel up to 75% 

• Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives 

• Excellent written and verbal communication skills 

• Proven ability to develop successful collaborations with internal and external partners 

The pay range for this role is $163,000-$191,000 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. The successful candidate will also be eligible for health benefits, 401(k) with 6% employer match from day one, ESPP with up to a 15% discount up to the federal limit, flexible spending account among other benefits 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.