Head, Project Management & Program Management

Job Description

Job Description

About Summit :

Ivonescimab, also 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 :

Reporting to the Chief Business & Strategy Officer, the Head of Project Management & Program Management will lead the project management office (PMO) responsible for cross-functional strategic and operational execution of development and ultimate regulatory approval and commercialization of ivonescimab. They will be responsible for driving cross-functional alignment, ensuring delivery of clinical development plans from Phase I through Phase III, and supporting regulatory filings including BLA, MAA, and other global submissions. The Head is accountable for establishing and maintaining an integrated project plan to cover all aspects of the ivonescimab development program(s), including clinical development, regulatory, biometrics, clinical operations, medical affairs, CMC / manufacturing, and commercial.

This leader will shape and oversee the Project Management and Program Management function, building best-in-class project & program management practices and strategic approaches in securing appropriate resources to drive results. They will lead and mentor a team of program and project management professionals and foster strong partnerships across internal teams and external collaborators, including co-development & licensing partners, CROs, and regulatory bodies to ensure program success and maximize portfolio value.

Role and Responsibilities :

Experience, Education and Specialized Knowledge and Skills :

The pay range for this role is $300,000-$350,000 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.

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