Summit Therapeutics, Inc.
Clinical Trial Manager – Summit Therapeutics, Inc.
Location:
Menlo Park, CA / Miami, FL / Princeton, NJ (onsite)
About Summit:
Summit Therapeutics is developing **ivonescimab**, a bispecific antibody targeting PD‑1 and VEGF, with ongoing Phase III trials (HARMONi series) in non‑small cell lung cancer.
Overview of Role:
The Clinical Trial Manager is a highly autonomous, experienced clinical operations professional responsible for all aspects of global clinical trial management for summit’s drug development program. Responsibilities include study start‑up, site management, CRO coordination, protocol development, regulatory compliance, and quality oversight.
Role & Responsibilities
Oversee study scope, quality, timelines, and budget with internal leads, CROs, and vendors to ensure project objectives are met.
Initiate and build solid professional relationships with key opinion leaders and site staff.
Partner with CRO to develop and execute robust patient enrollment and data monitoring strategies, ensuring on‑time completion.
Identify and manage study‑related risks proactively.
Develop and manage clinical trial documents (protocols, CRFs, consent documents, agreements).
Review and manage study plans and processes, including CTA, CRFs, statistical/pharmacokinetic plans, monitoring, data management, and safety monitoring.
Review CRO and vendor contracts and specifications.
Approve essential documents to enable timely site activations and monitor interim/closeout visit reports.
Direct investigator performance, address protocol deviations, and resolve enrollment issues.
Maintain Trial Master File (TMF) integrity and perform periodic QC.
Ensure compliance with GCP, national/international regulatory requirements and company SOPs.
Coach and oversee the activities of Clinical Trial Associates on the project.
Perform additional duties as assigned.
Qualifications & Experience
Bachelor’s degree or equivalent in life sciences, nursing, pharmacy, laboratory technology or related field (preferred).
Minimum 5 years of clinical project management experience in sponsor/biotech settings, with prior phase II and III experience.
Deep understanding of drug development process, ICH guidelines/GCP, and clinical trial workflow.
Experience with budget forecasting and management.
Oncology clinical trial experience.
Ability to travel internationally (up to 20%).
Proven leadership of large, complex studies managed in‑house and by CRO.
Strong interpersonal, decision‑making, and communication skills.
Proficiency in reviewing clinical data and writing documents.
Excellent planning, time‑management, and coordination skills.
Ability to work in a fast‑paced, team environment.
Demonstrated ability to build patient enrollment strategies and maintain TMF integrity.
Compensation Pay range: $134,500 – $158,000 per year, plus variable bonuses, stock, benefits, and other compensation.
Contact:
Summit does not accept referrals from employment agencies. Direct applications are accepted through the summit careers portal.
#J-18808-Ljbffr
Menlo Park, CA / Miami, FL / Princeton, NJ (onsite)
About Summit:
Summit Therapeutics is developing **ivonescimab**, a bispecific antibody targeting PD‑1 and VEGF, with ongoing Phase III trials (HARMONi series) in non‑small cell lung cancer.
Overview of Role:
The Clinical Trial Manager is a highly autonomous, experienced clinical operations professional responsible for all aspects of global clinical trial management for summit’s drug development program. Responsibilities include study start‑up, site management, CRO coordination, protocol development, regulatory compliance, and quality oversight.
Role & Responsibilities
Oversee study scope, quality, timelines, and budget with internal leads, CROs, and vendors to ensure project objectives are met.
Initiate and build solid professional relationships with key opinion leaders and site staff.
Partner with CRO to develop and execute robust patient enrollment and data monitoring strategies, ensuring on‑time completion.
Identify and manage study‑related risks proactively.
Develop and manage clinical trial documents (protocols, CRFs, consent documents, agreements).
Review and manage study plans and processes, including CTA, CRFs, statistical/pharmacokinetic plans, monitoring, data management, and safety monitoring.
Review CRO and vendor contracts and specifications.
Approve essential documents to enable timely site activations and monitor interim/closeout visit reports.
Direct investigator performance, address protocol deviations, and resolve enrollment issues.
Maintain Trial Master File (TMF) integrity and perform periodic QC.
Ensure compliance with GCP, national/international regulatory requirements and company SOPs.
Coach and oversee the activities of Clinical Trial Associates on the project.
Perform additional duties as assigned.
Qualifications & Experience
Bachelor’s degree or equivalent in life sciences, nursing, pharmacy, laboratory technology or related field (preferred).
Minimum 5 years of clinical project management experience in sponsor/biotech settings, with prior phase II and III experience.
Deep understanding of drug development process, ICH guidelines/GCP, and clinical trial workflow.
Experience with budget forecasting and management.
Oncology clinical trial experience.
Ability to travel internationally (up to 20%).
Proven leadership of large, complex studies managed in‑house and by CRO.
Strong interpersonal, decision‑making, and communication skills.
Proficiency in reviewing clinical data and writing documents.
Excellent planning, time‑management, and coordination skills.
Ability to work in a fast‑paced, team environment.
Demonstrated ability to build patient enrollment strategies and maintain TMF integrity.
Compensation Pay range: $134,500 – $158,000 per year, plus variable bonuses, stock, benefits, and other compensation.
Contact:
Summit does not accept referrals from employment agencies. Direct applications are accepted through the summit careers portal.
#J-18808-Ljbffr