Senior Director, CMC Strategy Development & Delivery

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 Director of CMC Strategy Development & Delivery will be responsible for developing and executing the strategic vision for CMC activities and supply chain operations. This role requires a visionary leader with extensive experience in late-phase development, regulatory filings, and strategic development/manufacturing/supply chain program/project management to ensure the successful ongoing process development, manufacturing, clinical supply, filing and launch of our lead asset, Ivonescimab.

Role and Responsibilities:

• Develop and implement a comprehensive CMC strategy for ongoing late-phase development, manufacture, supply, filing and product launch, ensuring alignment with regulatory requirements and industry standards.
• Own timely delivery of the key strategic objectives such as: implementation of key process changes, whilst balancing inventories/supply needs; introduction of new drug substance and drug product manufacturing sites with maximum time and cost efficiency; commercial launch readniess.
• Lead cross-functional strategic initiatives to optimize development activities, the end-to-end supply chain, from raw material sourcing to product distribution.
• Collaborate with external stakeholders and senior leadership to align CMC and supply chain strategies with overall business objectives and clinical development / product launch timelines.
• Identify, evaluate and execute the strategic partnerships and alliances to enhance CMC capabilities and supply chain resilience.
• Provide strategic oversight for technology transfer processes, ensuring seamless transition from development to commercial manufacturing.
• Anticipate, address and resolve potential regulatory and logistical challenges, developing proactive strategies to mitigate risks.
• Stay abreast of industry trends, advancements, and best practices, incorporating innovative approaches into CMC and supply chain strategies.
• Represent the company in high-level discussions with regulatory agencies, industry partners, and key stakeholders.
• Prepare and present strategic reports and updates to senior management and the board of directors.
• All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

• Bachelors degree in Chemistry, Biochemistry, Bio