Associate Director, Global Supply Planning

Location: US (Princeton, NJ) Onsite

Reports To: Executive Director, Global Commercial Supply Chain

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 of Global Supply Planning will lead the global supply planning activities for commercial products as per Summit’s commercialization schedule. This role is pivotal in translating commercial and global clinical trial demand into supply plans for our contract manufacturers, while ensuring safety stock levels are met. The role will monitor short term execution at the CMO’s, while ensuring that the medium- long term supply/ capacity plans are aligned with demand and delivery assumptions.

Roles and Responsibilities:

• Lead the S&OP process for commercial supply, collaborating closely with Finance, Commercial and other cross-functional teams to ensure a portfolio-based approach that aligns with business objectives.
• Lead, manage and execute the business processes and data analytics to ensure a robust and thorough review of demand, assumptions, risks, capacity and supply plans; evaluate performance metrics and manage the KPI’s related to Commercial Supply performance
• Support the implementation of the global supply chain strategy to further commercial goals, including product availability, cost optimization, and customer satisfaction.
• Collaborate with CMC, Commercial, Clinical, Finance, QA and operational teams, ensuring high levels of compliance, performance, and alignment with business objectives.
• Drive continuous improvement initiatives to enhance supply chain efficiency, sustainability, and resilience and streamline processes to reduce lead times and improve cost efficiency without compromising product quality.
• As needed, support supplier selection, negotiation, operations and performance management to ensure that partnerships align with organizational goals.
• Drive continuous improvement initiatives to enhance supply chain efficiency, sustainability, and resilience.
• Proactively identify and resolve issues within the supply chain that could affect the delivery of commercial products.
• Collaborate with appropriate functions on supporting the design and implementation of the ERP system for managing inventory and supply transactions, as necessary
• Ensure that all commercial supply chain activities comply with relevant regulatory requirements, including cGMP (current Good Manufacturing Practices), GDP (Good Distribution Practices), and country-specific regulations.
• Stay current with industry trends and evolving regulatory standards to ensure compliance and alignment with best practices.
• All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

• Bachelor’s degree in Supply chain management, Business, Operations, or a pharmaceutical industry related field.
• MBA or advanced degree in Supply Chain, Logistics, or a related field is preferred.

• A minimum of 7+ years of experience in global supply chain manageme