Career Opportunities with Summit Therapeutics Sub, Inc.
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Careers At Summit Therapeutics Sub, Inc.
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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 Clinical Research Associate (CRA) is responsible for supporting all aspects of Clinical Trial Management for complex, global studies from study planning and start-up through study close-out. This role will collaborate with functional team members, CROs, and vendors to successfully deliver clinical studies under direction from Clinical Trial Manager or Director. The CRA is responsible for adherence to all performance metrics and quality of deliverables in the clinical trial.
Role and Responsibilities:
Directs and completes communication between the project team and site personnel to ensure that they are appropriately trained, remain current with project requirements, and have a thorough understanding of study milestones and deliverables.
Reviews, approves, and tracks vendor invoices and manages accruals and payment process for all assigned clinical trial vendors, including investigational sites.
Initiates and builds solid professional relationships with clinical site staff.
Partners with the CRO to ensure robust ongoing data monitoring strategies carried out effectively to ensure delivery of high-quality data.
Creates and develops study trackers.
Develops and provides clear, complete documentation of study-specific meetings, action items, and action item closure for assigned study meetings.
Responsible for the development and management of clinical trial documents, including consent documents, site welcome packets, study binders, etc.
Responsible for reviewing assigned study-related plans, processes, agreements, and guidelines.
Follows and implements assigned study-related plans, processes, agreements, and guidelines.
Requests and logs CRO and vendor RFIs/RFPs contracts/work orders and specifications to enable study objectives to be met.
Reviews and approves essential document packages to enable timely site activations.
Conducts and tracks Monitoring Report Review to ensure compliance with procedures across the duration of the study and documentation is complete.
Provides close oversight of the findings on the monitoring reports and loops back with the broader team to provide updates as needed.
Assesses and supports investigator performance guidance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary.
Responsible for oversight of the maintenance of the TMF and completeness at the end of the study. Performs periodic QC of the TMF.
Oversees the execution of clinical trial activities in accordance with Good Clinical Practices. Ensures compliance of clinical trials with national regulatory requirements and co-monitors the assigned clinical trial following company SOPs.
Ensures the study is “inspection ready” contemporaneously.
Responsible for supporting functional activities of Clinical Trial Associates allocated to the project through leadership and training as indicated and appropriate.
All other duties as assigned.
Experience, Education, and Specialized Knowledge and Skills:
Bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred.
A minimum of 3+ years of clinical research experience in conducting clinical trials.
Prior phase II or III experience required.
A solid understanding of recruitment methods, drug development process, ICH guidelines/GCP, and specifically, each step within the clinical trial process.
Experience with clinical studies in oncology and/or rare diseases is a plus.
Sophisticated understanding and highly skilled utilization of Microsoft Apps such as Outlook, Word, Excel, and Teams.
Ability to travel internationally to visit clinical sites and for study meetings. Amount will vary upon project needs (up to 20%).
Tenacity to work in a fast-paced team environment.
Enjoys building relationships with KOLs and site personnel. Willing to travel to establish relationships.
Ability to successfully engage and work collaboratively with global team members/colleagues.
Ability to support building and delivery of patient enrollment strategies.
Excellent interpersonal and decision-making skills. Demonstrates innovation, possesses drive, energy, and enthusiasm to deliver program objectives.
Ability to review and assess clinical data.
Possesses excellent planning, time management, and coordination skills.
Demonstrated ability to problem-solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs.
Experience in working in a small organization is a plus.
Excellent written and oral communication skills.
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