About Summit:
Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody that combines immunotherapy via PD-1 blockade with anti-angiogenesis effects by blocking VEGF. Ivonescimab exhibits unique cooperative binding to its targets, with higher affinity in the presence of both PD-1 and VEGF.
Summit has initiated clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials:
* HARMONi: a Phase III trial evaluating ivonescimab combined with chemotherapy versus placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after third-generation EGFR TKI treatment.
* HARMONi-3: a Phase III trial assessing ivonescimab combined with chemotherapy versus pembrolizumab plus chemotherapy as first-line treatment for metastatic NSCLC.
* HARMONi-7: a Phase III trial comparing ivonescimab monotherapy to pembrolizumab monotherapy in patients with first-line metastatic NSCLC with high PD-L1 expression.
Ivonescimab is an investigational therapy not yet approved by regulatory authorities in Summit's license territories, including the US and Europe. It was approved for marketing in China in May 2024 and has received Fast Track designation from the FDA for the HARMONi trial.
Overview of Role:
The Associate Director, Clinical Scientist, will lead and contribute to the design and execution of hematology/oncology clinical studies. This role involves collaborating with various teams to develop clinical plans, authoring regulatory documents, and ensuring high-quality data interpretation. The individual will also focus on study enrollment, building relationships with investigators and site staff, and proactively managing study execution challenges.
Responsibilities:
* Lead and contribute to study design and amendments with scientific stakeholders.
* Collaborate on protocol development, regulatory filings, and submissions.
* Work with clinical operations and data management to ensure data quality and safety monitoring.
* Serve as a point of contact for CROs and stakeholders regarding clinical inquiries.
* Develop clinical presentation materials for meetings and communications.
* Assist in developing study start-up documents and resources.
* Participate in safety reviews and trend analysis.
* Support communication strategies for studies, including interactions with KOLs and publication activities.
* Contribute to scientific meeting submissions and regulatory documentation.
* Perform other duties as assigned.
Qualifications:
* MS or equivalent required; PhD, PharmD, or MD preferred.
* At least 3 years of related experience with a PhD or similar degree.
* Excellent communication skills.
* Expertise in immunology/immuno-oncology translational and clinical data interpretation.
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