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 Director of External Supply Leader (Packaging) will support development of the strategy and participate in the execution of Summit’s global supply chain plans for commercial product(s). This role is pivotal in ensuring the efficient and compliant delivery of high-quality pharmaceuticals to customers worldwide. The successful candidate will oversee the launch of commercial products in US and global markets, lead the tactical aspects of Summit’s engagement with external packaging operations partners, including managing vendor relationships.

Roles and Responsibilities:

• Lead & support the launch related activities for US and global markets including serialization activities, validation, and coordination of artwork generation process, as they relate to the supply chain process to ensure all launch-related goals are met.
• Act as the main point of contact for managing the interactions with all commercial packaging vendors and the operations contact for the commercial 3PL.
• Manage the ongoing supply related activities with the commercial packaging vendors to ensure on time delivery of finished goods at commercial distribution facility.
• 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, Finance, QA and operational teams, ensuring high levels of compliance, performance, and alignment with business objectives.
• Proactively identify and resolve issues with supply chain and drive continuous improvement initiatives to enhance supply chain efficiency, sustainability, resilience, reduce lead times, and improve cost effectiveness in the commercial packaging domain without compromising product quality.
• Ensure the forecasted demand is aligned with production and distribution capabilities, optimizing inventory levels and minimizing excess or shortages.
• Ensure that the packaging vendors are executing to the operational forecasts and plans as directed by the cross functional teams.
• Lead quarterly or bi-annual business review meetings with the assigned vendors.
• As needed, support supplier selection, negotiation, operations and performance management to ensure that partnerships align with organizational goals.
• Manage any third-party manufacturers (CMOs), as assigned, and logistics providers to ensure the highest standards and adherence to timelines.
• Lead efforts to streamline processes, reduce lead times, and improve cost-efficiency without compromising product quality.
• 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, Engineering, Operations, or a pharmaceutical industry related field.

• MBA or advanced degree in Supply Chain, Logistics, or a related field is preferred.
• Minimum of 10+ years of experience in global supply chain management and manufacturing operations in the pharmaceutical/ biotech area.

• Extensive experience in managing commercial supply chain operations, including expedited launches, demand forecasting, inventory management, manufacturing operations and distribution logistics.
• Proven experience working with third-party manufacturers (CMOs) and logistics providers, ensuring quality standards and on-time delivery.
• Deep understanding of regulatory and compliance standards in the biotech industry (e.g., cGMP, GDP, and other global regulations).
• Strong experience in managing global teams and driving cross-functional collaboration.
• Excellent analytical and problem-solving skills with the ability to make data-driven decisions.
• Expertise in supply chain management software (ERP, SAP, etc.) and advanced Excel skills.
• Strong communication skills, both verbal and written, with the ability to convey complex ideas clearly and effectively.
• Ability to thrive in a fast-paced, dynamic environment, managing multiple priorities simultaneously.

The pay range for this role is $184,000-$230,000 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.

Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.