Summit Therapeutics, Inc.
Location:
Menlo Park, CA, Princeton NJ or Miami FL. onsite 4 days per week
About Summit
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 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 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 Responsibilities
Oversee study scope, quality, timelines, and budget with internal Summit functional leads, CROs, and vendors to ensure overall project objectives are met.
Initiate and build solid professional relationships with key opinion leaders and clinical site staff.
Partner with the CRO to ensure robust patient enrollment strategies are developed and carried out effectively to ensure enrollment is completed on time.
Partner with the CRO to ensure robust ongoing data monitoring strategies are developed and carried out effectively to ensure delivery of high‑quality data.
Proactively identify and manage study‑related risks.
Develop and manage clinical trial documents including protocols, Case Report Forms (CRFs), consent documents, confidentiality agreements.
Review and manage study‑related plans and processes including investigator agreements (CTA), CRFs, CRF guidelines, statistical/pharmacokinetic analysis plans, monitoring plan, data management and safety monitoring.
Review CRO and vendor contracts/work orders and specifications to enable study objectives to be met.
Approve essential document packages to enable timely site activations.
Review pre‑study, study initiation, interim monitoring visit and at‑study closeout visit reports.
Provide close oversight on findings from monitoring reports and loop back with broader team to provide updates.
Direct investigator performance and adherence to protocol; proactively address conduct issues and enrollment problems as needed.
Oversee maintenance of the TMF and its completeness at the end of the study.
Perform periodic QC of the TMF.
Oversee the execution of clinical trial activities in accordance with Good Clinical Practices; ensure compliance with national and international regulatory requirements and co‑monitoring responsibilities following company SOPs.
Ensure the study is “inspection ready” at all times.
Oversee and coach functional activities of Clinical Trial Associates allocated to the project.
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.
Minimum of 5+ years of clinical project management experience in conducting international clinical trials in sponsor Pharma/Biotech organizations.
Prior phase II and III experience required.
Solid understanding of drug development process, ICH guidelines/GCP and specifically each step within the clinical trial process.
Experience with budget forecasting and management.
Experience with clinical studies in oncology.
Ability to travel internationally to visit clinical sites and for study meetings (up to 20%).
Proven proficiency in overseeing large complex studies managed in‑house and by a CRO.
Demonstrated ability to lead teams and work in a fast‑paced environment.
Experienced in building relationships with KOLs and site personnel.
Ability to successfully engage and work collaboratively with overseas clinical operations team members.
Demonstrated ability to build and deliver on patient enrollment strategies.
Excellent interpersonal and decision‑making skills; demonstrates innovation, drive, energy, enthusiasm to deliver program objectives.
Demonstrated ability to comprehend complex scientific concepts and data.
Proficient in reviewing and assessing clinical data.
Possesses excellent planning, time management and coordination skills.
Demonstrated ability to solve problems and use clear judgment in relation to regulatory requirements, external party interactions, timelines, and complex clinical programs.
Experience in working in a small organization.
Excellent written and oral communication skills.
Pay Range:
$134,500 - $158,000 per year. Compensation may include bonus, stock, benefits and other variable components.
Summit 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.
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Menlo Park, CA, Princeton NJ or Miami FL. onsite 4 days per week
About Summit
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 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 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 Responsibilities
Oversee study scope, quality, timelines, and budget with internal Summit functional leads, CROs, and vendors to ensure overall project objectives are met.
Initiate and build solid professional relationships with key opinion leaders and clinical site staff.
Partner with the CRO to ensure robust patient enrollment strategies are developed and carried out effectively to ensure enrollment is completed on time.
Partner with the CRO to ensure robust ongoing data monitoring strategies are developed and carried out effectively to ensure delivery of high‑quality data.
Proactively identify and manage study‑related risks.
Develop and manage clinical trial documents including protocols, Case Report Forms (CRFs), consent documents, confidentiality agreements.
Review and manage study‑related plans and processes including investigator agreements (CTA), CRFs, CRF guidelines, statistical/pharmacokinetic analysis plans, monitoring plan, data management and safety monitoring.
Review CRO and vendor contracts/work orders and specifications to enable study objectives to be met.
Approve essential document packages to enable timely site activations.
Review pre‑study, study initiation, interim monitoring visit and at‑study closeout visit reports.
Provide close oversight on findings from monitoring reports and loop back with broader team to provide updates.
Direct investigator performance and adherence to protocol; proactively address conduct issues and enrollment problems as needed.
Oversee maintenance of the TMF and its completeness at the end of the study.
Perform periodic QC of the TMF.
Oversee the execution of clinical trial activities in accordance with Good Clinical Practices; ensure compliance with national and international regulatory requirements and co‑monitoring responsibilities following company SOPs.
Ensure the study is “inspection ready” at all times.
Oversee and coach functional activities of Clinical Trial Associates allocated to the project.
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.
Minimum of 5+ years of clinical project management experience in conducting international clinical trials in sponsor Pharma/Biotech organizations.
Prior phase II and III experience required.
Solid understanding of drug development process, ICH guidelines/GCP and specifically each step within the clinical trial process.
Experience with budget forecasting and management.
Experience with clinical studies in oncology.
Ability to travel internationally to visit clinical sites and for study meetings (up to 20%).
Proven proficiency in overseeing large complex studies managed in‑house and by a CRO.
Demonstrated ability to lead teams and work in a fast‑paced environment.
Experienced in building relationships with KOLs and site personnel.
Ability to successfully engage and work collaboratively with overseas clinical operations team members.
Demonstrated ability to build and deliver on patient enrollment strategies.
Excellent interpersonal and decision‑making skills; demonstrates innovation, drive, energy, enthusiasm to deliver program objectives.
Demonstrated ability to comprehend complex scientific concepts and data.
Proficient in reviewing and assessing clinical data.
Possesses excellent planning, time management and coordination skills.
Demonstrated ability to solve problems and use clear judgment in relation to regulatory requirements, external party interactions, timelines, and complex clinical programs.
Experience in working in a small organization.
Excellent written and oral communication skills.
Pay Range:
$134,500 - $158,000 per year. Compensation may include bonus, stock, benefits and other variable components.
Summit 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.
#J-18808-Ljbffr