Senior Project Manager

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Ivonescimab, known as SMT
112, 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.

The Associate Director of Project Management sits within the Program Management and Business Strategy department and is pivotal in contributing to a fit for purpose PMO and driving cross-functional execution and operational excellence across oncology development programs, particularly Phase 2 and beyond. The Associate Director will serve as a strategic integrator, aligning corporate and clinical development goals with functional execution across departments such as Clinical Operations, Development, Biometrics, Regulatory, Clinical Pharmacology, Biomarker Strategy, Bioanalytical, New Indication Planning, Quality, IT and Compliance.

This role will be responsible for building and refining infrastructure and processes that support scalable, transparent, and adaptive program execution. This includes dashboarding, process improvement and continuous monitoring to ensure visibility, accountability, and agility as the organization grows and our pipeline evolves.

• Project Management
  • Develop integrated project plans, timelines, and templates from scratch tailored to program, cross functional, and governance needs.
  • Drive execution of project milestones, proactively identifying risks and mitigation strategies.
  • Ensure alignment between functional execution and strategic program goals.
  • Lead and manage ad-hoc cross functional work streams on specific initiatives.
• Functional Integration
  • Serve as a project management strategic liaison to 1–2 functional departments (e.g., Clin Ops, Biometrics, Clinical Quality, Clin Dev).
  • Translate functional needs into actionable infrastructure and project plans.
  • Support functional teams in achieving operational excellence and compliance.
• Process Improvement & PMO development
  • Design and implement scalable, adaptable processes that support program execution.
  • Lead initiatives to improve operational efficiency, transparency, and agility.
  • Ensure all infrastructure initiatives are documented and integrated into the PMO library.
  • Apply continuous monitoring and feedback loops to refine processes as the organization evolves.
• Develop and maintain dashboards using Smartsheets and other tools to track timelines, deliverables, and risks.
• Ensure real-time visibility into project status for leadership and stakeholders.
• Champion data-driven decision-making through effective…