Associate Director, CMC/Quality Project Management (Biologics)

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 Associate Director, Project Management (CMC, Quality) is an individual contributor position that will play a critical role in driving the success of Summit programs and with prioritized focus in CMC, Supply, Quality and Business activities. This role will provide CMC / Quality program leadership in cross-functional team settings and will help build the infrastructure, tools and processes contributing to the success of Program Management department. They will provide strategic and operational leadership for CMC and Quality deliverables across the biologics development lifecycle—from early clinical phases through BLA submission and post-approval changes.

Working within a matrixed environment, this position will collaborate across Process Development, Analytical Development, Quality, Regulatory Affairs, Manufacturing, external partners (CDMOs/CROs) to deliver high-quality submissions and commercialization readiness. This role requires flexible, execution-focused capabilities with the ability to take on additional responsibilities as the department/company grow.

Role and Responsibilities:

• Cross-functional Collaboration and CMC Leadership

• Represent the Program Management department in cross-functional teams with clinical development, non-clinical and/or regulatory focus

• Integrate Analytical Development/Quality Control (QC), Drug Product development and manufacturing, and end-to-end Supply Chain to ensure robust control strategies, inspection readiness, and reliable supply.

• Develop and maintain detailed CMC submission plans, timelines, and risk mitigation strategies for BLA and other regulatory filings

• Prepare high-impact presentations, decision memos, and status reports for senior management and governance forums

• Can quickly build strong and sustaining relationships with stakeholders at all levels

• Lead key activities or assigned projects, which may rapidly evolve based on business needs

• Implement and refine program tools, workflows, and processes to enhance efficiency, transparency, and quality of CMC operations

• Strategic Responsibilities:

• Ensure alignment in CMC strategy for early stage IND/IMPD and late-stage biologics suitable for BLA/ MAA filings (including characterization, control strategy, comparability, stability, regulatory expectations)

• Ensure alignment of CMC deliverables with project milestones and product target profile through data-driven and risk-based decision-making

• Engage in cross-functional governance and steering committees to influence and guide program direction.

• Monitor global regulatory trends (FDA, EMA, PMDA, ICH) to anticipate changes and manage compliance strategies in submissions.

• Project Management

• Maintain decision-quality approaches