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, Clinical Scientist is responsible for leading/contributing to study design and execution of clinical studies in hematology/oncology. As a leader within the clinical organization, this individual will be partnering with clinical operations, translational, and other matrix team members to design and refine clinical plans, authoring key clinical/regulatory documents, and ensuring exceptional delivery and interpretation of clinical data. The Director, Clinical Scientist will strive to drive study enrollment, and build and maintain collaborative relationships with investigators and clinical site staff, CROs, and Summit colleagues. The Director, Clinical Scientist will foster a proactive and thoughtful approach to clinical study execution where obstacles are anticipated and effectively mitigated/resolved.
Role and Responsibilities:
* Leads/Contributes to study design and amendments in collaboration with internal and external scientific stakeholders
* Collaborates with MD, regulatory and other internal partners/stakeholders with authoring and submission of protocols, protocol amendments, regulatory filings, and other regulatory documentation
* Collaborates with clinical operations, data management and CRO to develop and implement the overall data quality plan and leads internal medical data review and safety trend analysis on one or more studies/programs
* Point-of-contact for clinical inquiries from CRO medical monitor and other stakeholders
* Develops and provides input for clinical presentation slides and other materials for internal/external meetings and/or ongoing communications (e.g., investigator meetings, pre-study site selection visits, study coordinator or clinical research administrator training, study newsletters, communications to study sites, etc.)
* Partners with clinical operations and CRO in developing and maintaining study start up documents/resources (e.g., ICF, Lab Manual, EDC, Safety monitoring Plan, etc.)
* Participates in safety meetings and tracks, analyzes, and reviews documentation for any potential safety events
* Leads/Contributes to the development and implementation of communications strategies to support existing and concluded studies. Includes KOL interactions, advisory boards, major medical meetings, congresses and other events, publications and other materials
* Writes and/or reviews abstracts, posters, content for scientific meetings, conferences, other events and presentations, and other publicly distributed materials and coordinates further reviews with internal partners and stakeholders
* Coordinates submissions to scientific meetings and/or other appropriate venues or groups
* Writes clinical science sections of meeting packages and assists in the development and review of other clinical documentation required for regulatory submissions and other regulatory processes
* All other duties as assigned
Experience, Education and Specialized Knowledge and Skills:
* MS (or equivalent) required,
* PhD, PharmD, or MD preferred
* 5+ years overall related experience with PhD or like degree; Minimum of 2 years’ experience in conducting / supporting oncology/hematology clinical studies
* Excellent written and verbal communication skills
* Expertise in interpreting immunology/immuno-oncology translational data in addition to clinical data
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