Site Contracts Associate

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

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 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:

We areseekinga detail-oriented and motivatedSite Contracts Associateto joinSummitsStudy Start Up group. This role is critical in supporting clinical trial site payment operations usingSummitspreferred vendor paymentsplatform. The ideal candidate will have experience in site paymentprocessing financial compliance and cross-functional collaboration to ensuretimelyaccurate and compliant payments to clinical research sites.

Role and Responsibilities:

• Serve as the primary liaison for internal teams (Clinical Operations Finance) site payment vendors and external site representatives for site payment set up andpayment queries.

• Serve as the primary point of contact for configuration and maintenance of complex site budgets in vendorplatformfor new and ongoing studies.

• Review and understand site agreements to resolve vendor platform budget set up issues with minimal oversight.

• Review executedsite contractsto confirmcorrectconfiguration of payment schedules andfees.

• Attendinternal study meetings andutilizeinternal trackers to ensureappropriate prioritizationof site budget set up.

• Ensure adherence to sponsor and regulatory requirements for financial transparency and Sunshine reporting.

• Support budgeting andbenchmark database

• Collaborate with Legal Finance CRO and clinical teams to ensure payment processescomply withregulatory and company standards.

• Support vendor management activities including monitoring deliverables and service-level agreements.

• Develop and implement innovative ideas and solutions to increase the efficiency of the department.

• All other duties as assigned.

Experience Education and Specialized Knowledge and Skills:

• Bachelors degree in FinanceAccountingBusiness Administration or related fieldrequired.

• Minimum of 2yearsexperience in clinical research finance site payments orcontractsmanagement.

• Experience withvendorpayment platformspreferred.

• Experience working with site payments on a global scale is desirable.

• Knowledge of clinical trial budgeting and financial lifecycle management.

• Experience with vendor oversight and cross-functional collaboration.

• Strong analytical skills withproficiencyin Microsoft Excel and financial reporting tools.

• Excellent communication and stakeholder management abilities.

• Critical thinking problem solving and ability to work independently.

• Must be able to effectively multi-task and manage time-sensitive and highly confidential documents.

• Ability to work in a fast-paced demanding and collaborative environment.

• Knowledge of GCP guidelines and relevant regulatory requirements.

The pay range for this role is $42 - $50/hr. 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 atto obtain prior written authorization before referring any candidates to Summit.