Overview

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, HARMONi-3, and HARMONi-7. HARMONi is a Phase III trial evaluating ivonescimab with chemotherapy versus placebo plus chemotherapy in EGFR-mutated, locally advanced or metastatic non-squamous NSCLC after progression on a 3rd generation EGFR TKI. HARMONi-3 compares ivonescimab with chemotherapy to pembrolizumab with chemotherapy in first-line metastatic NSCLC. HARMONi-7 compares ivonescimab monotherapy to pembrolizumab monotherapy in first-line metastatic NSCLC with 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 Medical Director will help oversee global clinical trials and BLA (Biologic Licensing Application) filings. The incumbent will be primarily responsible for developing and executing integrated clinical trial programs including protocol design and medical oversight of new or ongoing studies. They will be responsible for obtaining scientific advisory input, work with biostatisticians for design and analyses, support regulatory interactions for product advancement, and work closely with clinical operations to provide advice and decision making regarding medical input to achieve operational excellence.

The candidate will serve as a key medical expert for multiple cross functional teams. This position will provide medical insight across a myriad of functions from discovery to manufacturing. Additionally, the Associate Medical Director will play a pivotal role in leading investigator engagements including travel to support face-to-face interaction and protocol training. The Associate Medical Director will serve as a leader on one or multiple, potentially pivotal, programs.

Role and Responsibilities

• The role will require knowledge in the treatment and management of oncology disease such that knowledge can be applied to the strategy and clinical development of Summit medicines to benefit patients.
• Work cross functionally with Medical Affairs, Regulatory, Commercial and other functions to develop the overall product strategy in multiple indications
• Work cross functionally with Clinical Operations, Biometrics, Pharmacovigilance, and other functions to successfully complete clinical development programs leading to BLA approvals
• Lead teams to execute on clinical development goals (clinical trial execution, clinical development strategy, medical affairs planning)
• Contribute to the communication strategy of Summit products via publications, manuscripts, abstracts, posters and scientific presentations
• Making vital contributions on pivotal programs in clinical development program
• Directing human clinical trials, phases 1-3, for lead candidate in development, helping to ensure all clinical development milestones are met including enrollment goals
• Participating in medical review of adverse event reports and monitoring of incoming safety data in conjunction with product safety/pharmacovigilance, including evaluating and escalating safety signals
• Coordinate and develop information for reports submitted to FDA, EMA, PMDA, and government, regulatory, or partner agencies
• Presentations to various external stakeholders - regulators, governing and harmonization bodies, principal investigators, scientific conference attendees, advisors and opinion leaders
• Knowledge of clinical trial conduct to support operational needs for planning and executing clinical trials, including adherence to protocols, safety reviews, assay development, training, and clinical document review
• Planning, reviewing and editing Clinical Study Reports
• Planning, reviewing and editing publications from the program
• Providing input on the design of clinical studies supporting clinical strategy
• All other duties as assigned

Experience, Education and Specialized Knowledge and Skills

• MD or equivalent medical degree.
• Board certified or eligible preferred.
• Oncology experience is preferred.
• Minimum of 1+ years’ experience in pharmaceutical, biologics, or biotech R&D environment, or clinical experience/practice, or in a research environment involving the collection and analysis of human data.
• Working knowledge of clinical development pathways for hematology/oncology therapeutics in the US and EMA.
• Self-starter who will move forward with key initiatives without being prompted, able to perform a myriad of tasks needed to support the clinical development program, possesses a highly entrepreneurial and growth mindset, works collaboratively with cross-functional teams, loves a good mission