Clinical Trial Manager

Join to apply for the Clinical Trial Manager role at Summit Therapeutics, Inc.Join to apply for the Clinical Trial Manager role at Summit Therapeutics, Inc.About SummitIvonescimab, known as SMT112, is a novel, potential first-in-class investigationalAbout SummitIvonescimab, known as SMT112, is a novel, potential first-in-class investigationalbispecific 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 RoleThe Clinical Trial Manager is a highly autonomous and experienced clinical operations professional responsible for all aspects of Clinical Trial Management for global studies. Responsible for study start up and maintenance through study close out. Coordinates, leads and drives leads Summit cross functional team members, CROs and vendors to successfully deliver clinical studies. Responsible for all performance metrics and quality of deliverables in the clinical trial.Role And ResponsibilitiesOversees study scope, quality, timelines, and budget with the internal Summit functional leads, CRO and vendors to ensure that overall project objectives are metInitiates and builds solid professional relationships with key opinion leaders and clinical site staffPartners with the CRO to ensure robust patient enrollment strategies are developed and carried out effectively to ensure patient enrollment is completed on timePartners with the CRO to ensure robust ongoing data monitoring strategies are developed and carried out effectively to ensure delivery of high-quality dataProactive identification and management of study related risksResponsible for the development and management of clinical trial documents including (but not limited to) protocols, Case Report Forms (CRFs), consent documents, confidentiality agreementsResponsible for reviewing and managing study related plans, processes includingInvestigator agreements (CTA), CRFs, CRF guidelines, statistical / pharmacokinetic analysis plans, monitoring plan, data management, safety monitoringResponsible for reviewing CRO and vendor contracts/work orders and specifications to enable study objectives to be metReviews and approves essential document packages to enable timely site activationsReviews pre-study, study initiation, interim monitoring visit and at study closeout visit reportProvides close oversight on the findings on the monitoring reports and loops back with broader team to provide updatesDirects investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessaryResponsible for oversight on the maintenance of the TMF and completeness at the end of the studyPerform periodic QC of the TMFOversee the creation and execution of clinical trial activities in accordance with Good Clinical Practices. Ensure compliance of clinical trials with national and international regulatory requirements and co-monitoring the assigned clinical trial following company SOPsEnsures the study is “inspection ready” alwaysResponsible for oversight and coaching of the functional activities of Clinical Trial Associates allocated to the projectAll other duties as assignedExperience, Education And Specialized Knowledge And SkillsBachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred5+ years of clinical project management experience in conducting international clinical trials in sponsor Pharma/Biotech organizationPrior phase II and III experience requiredA solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial processExperience with budget forecasting and managementExperience with clinical studies in oncologyAbility to travel internationally to visit clinical sites and for study meetings. Amount will vary upon project needs (up to 20%)Proven proficiency in overseeing large complex studies being managed in house and by a CRODemonstrated ability to lead teams and work in a fast-paced team environmentExperienced and enjoys building relationships with KOLs and site personnelAbility to successfully engage and work collaboratively with overseas clinical operations team members/colleaguesDemonstrated ability to build and deliver on patient enrollment strategiesExcellent interpersonal and decision-making skills. Demonstrates innovation, possesses drive, energy, and enthusiasm to deliver the program objectivesDemonstrated ability to comprehend complex scientific concepts and dataProficient in reviewing and assessing clinical dataPossesses excellent planning, time management & coordination skillsDemonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programsExperience in working in a small organizationExcellent written and oral communication skillsSummit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.Seniority levelSeniority levelMid-Senior levelEmployment typeEmployment typeFull-timeJob functionJob functionStrategy/Planning and Information TechnologyReferrals increase your chances of interviewing at Summit Therapeutics, Inc. by 2xSign in to set job alerts for “Clinical Trial Manager” roles.Aseptic Services Manager for Clinical Trials Aseptic Services UnitOxford, England, United Kingdom 12 hours agoGlobal Trial Manager, Late Phase Studies, Single-Sponsor Dedicated (home-based in Europe)Reading, England, United Kingdom 2 weeks agoRegional Trial Delivery Manager - Sponsor DedicatedReading, England, United Kingdom 1 month agoGlobal Senior Trial Delivery Manager - Sponsor DedicatedReading, England, United Kingdom 1 week agoAbingdon-On-Thames, England, United Kingdom 6 days agoAbingdon-On-Thames, England, United Kingdom 1 week agoReading, England, United Kingdom 3 weeks agoHigh Wycombe, England, United Kingdom 5 days agoWitney, England, United Kingdom 6 days agoReading, England, United Kingdom 2 weeks agoExperienced Clinical Research Associate, Sponsor DedicatedReading, England, United Kingdom 2 weeks agoReading, England, United Kingdom 2 weeks agoReading, England, United Kingdom 1 week agoReading, England, United Kingdom 1 week agoReading, England, United Kingdom 6 days agoExperienced Clinical Research Associate, Sponsor DedicatedReading, England, United Kingdom 1 week agoReading, England, United Kingdom 1 month agoAssociate Site Manager Early DevelopmentHigh Wycombe, England, United Kingdom 1 week agoReading, England, United Kingdom 1 week agoWe’re unlocking community knowledge in a new way. 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