Senior Financial Analyst (R&D Finance/Accounting)

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:

Reporting to the Manager of Financial Operations, the Senior Financial Analyst plays a key part in ensuring accurate financial operations and compliance across the company.

Role and Responsibilities:

• Support the Manager, Financial Operations with the monthly close process to ensure timely and accurate financial reporting, with a focus on continuous process improvement and reducing close timelines.
• Prepare and review high visibility CRO entries, Investigator Grant entries and other R&D entries.
• Own and review the accounting and financial tracking for clinical trial accruals, working closely with cross-functional teams to ensure the data is complete, accurate, and audit-compliant.
• Lead site payments process with 3rd party vendor clinical sites by reviewing invoices, checking them against Clinical Trial Agreements (CTAs), working with the Clinical Operations team and resolving any issues quickly and timely.
• Serve as a key point of contact for operational accounting inquiries, providing guidance and technical accounting expertise to cross-functional teams.
• Collaborate cross-functionally with other teams like Clinical Operations, Vendor Management and Legal to support strategic business objectives and ensure the accuracy of financial information.
• Maintain and monitor SOX controls related to operational accounting are completed on time and are working as intended. Proactively identify and escalate any control deficiencies.
• Support financial systems optimization and upgrades, including implementing systems/tools and making the most of SAP By Design features.
• Assist with audit preparation by gathering needed documents, preparing schedules (PBCs), and responding to audit requests.

Experience, Education and Specialized Knowledge and Skills:

• Bachelor’s degree in finance, business, accounting or related field preferred
• CPA or progress toward designation preferred
• A minimum of 4+ years of experience in accounting
• Experience in the life sciences industry, with prior exposure to clinical study accruals strongly preferred