Accounting Manager, R&D

Job Title: Accounting Manager R&D

Department: Finance

Location: Menlo Park CA ONSITE

Job Type: Full-Time

ACCOUNTING MANAGER R&D

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:

Reporting to the Director of Accounting the Accounting Manager (R&D) will be an integral member of the Accounting team primarily focused on the accounting for the Companys multiple ongoing and planned clinical trials. This role will be focused on the preparation of monthly journal entries and ensuring completeness and accuracy of the Companys clinical trial-related expenses. In this role you will assist in analyzing the monthly clinical trial expenses working with the clinical operations team and third-party vendors. Attention to detail and adherence to ongoing deadlines will be important for success in this role.

Role and Responsibilities:

• Review contracts to determine appropriate accounting treatment in accordance with US GAAP and document conclusions

• Work with Clinical Research Organizations (CRO) to obtain details of direct and pass-through costs incurred on a monthly basis

• Calculate clinical trial patient costs monthly using EDC data

• Assist with contract manufacturing accrual

• Prepare monthly accrual journal entries with detailed supporting workpapers to account for all costs of the Companys clinical trials

• Analyze monthly clinical trial expenses reported by third-party CRO vendors and partner with questions with the Clinical Operations team and CROs as needed

• Prepare commentary for the monthly and quarter-end close fluctuation analysis

• Assist with internal and external auditor requests

• Prepare monthly account reconciliations for assigned accounts

• Participate in process improvements financial system implementations and/or enhancements

• Assist with ad hoc projects as needed

• All other duties as assigned

Experience Education and Specialized Knowledge and Skills:

• Bachelors degree in accounting or related field required; CPA preferred

• Minimum 5 years of work experience; 3 years of Phase II/III clinical stage biotech/pharma industry experience preferred

• Strong understanding of US GAAP and Sarbanes-Oxley compliance requirements

• Results-oriented strong organizational skills and time management skills with ability to multi-task

• A team player willing to step in and help with other areas of accounting

• Excellent analytical interpersonal verbal and written communication skills

• Superb analytical strategic and critical thinking skills with impeccable attention to detail and strong prioritization and problem-solving skills

• Demonstrated ability to operate in a fast-paced environment

• Attention to detail accuracy and confidentiality

• Excellent organizational management analytical & decision-making skills

• An ability to work well cross functionally and across geographies

• Impeccable integrity and a strong work ethic

The pay range for this role is $118500 - $139500 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.

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