Manager, Clinical Study Start Up (Contract)

*THIS IS A TEMPORARY POSITION*

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:

We are seeking an experienced and highly motivated Manager to join our team. This role is crucial in managing site agreements to support our programs. The ideal candidate will have extensive experience in site contract and budget negotiation, as well as managing relationships with clinical research sites. You will support clinical benchmarking and site budget development, escalation, and payment activities for the Clinical Operations department. You will partner with functional leads of departments to establish strategic approaches to fair market value negotiations and enable site activations.

 

Role and Responsibilities:

• Under minimal guidance, develop pricing strategies for site budgets to enable contract execution and site activation
• Collaborate with legal, finance, CRO and clinical teams to ensure site agreements comply with regulatory and company standards
• Negotiate and finalize site agreements, including budgets, contracts, and other necessary documentation. Knowledge of CTA legal risks and possible fallback language required
• Rigorous analysis of budgets with the goal of securing the best price
• Confidently present the budget to the Chief Accounting Officer for approval, ensuring full knowledge of all details
• Partner with Clinical Finance team to provide study-wide site payment estimates and forecasts
• Work with legal counsel to ensure appropriate indemnification, liability, and confidentiality provisions are included in contracts
• Provide regular updates to study management on progress and key performance indicators related to trial agreements
• Work with Finance and Clinical Leadership as needed to address budget, invoice, payment, and PO concerns
• Collaborate with external functional service providers (FSP) on site budget templates, study-level work orders and POs, and site payment processes
• Build and maintain strong relationships with CROs, FSP providers, and clinical sites
• Monitor FSP providers and ensure adherence to project timelines, quality standards, and contractual obligations
• Ensure timely and cost-effective solutions that meet project timelines and budgets
• Address and resolve any i