Summit Therapeutics, Inc. · 9 hours ago
Associate Director, Clinical Operations
Menlo Park, CA
Full-time
Onsite
Lead/Staff, Director/Executive
$168K/yr - $198K/yr
3+ years expSummit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life through innovative clinical studies. The Associate Director, Clinical Operations will manage all aspects of Clinical Trial Management for global studies, ensuring successful delivery through coordination with cross-functional teams, CROs, and vendors.
BiotechnologyHealth CareMedical DeviceTherapeutics
Responsibilities
Oversees study scope, quality, timelines, and budget with the internal Summit functional leads, CRO, and vendors to ensure that overall project objectives are met
Fosters solid professional relationships with key opinion leaders and clinical site staff
Partners with CRO(s) to ensure robust patient enrollment strategies are developed and carried out effectively and on time
Partners with CRO(s) to ensure robust ongoing data monitoring strategies are developed and carried out effectively to ensure delivery of high-quality data
Proactive identification and management of study related risks
Responsible for the development and management of clinical trial documents including (but not limited to) protocols, Case Report Forms (CRFs), consent documents, confidentiality agreements
Responsible for reviewing and managing study related plans, processes including
Investigator agreements (CTA), CRFs, CRF guidelines, statistical / pharmacokinetic analysis plans, monitoring plan, data management, and safety monitoring
Reviews CRO(s) and vendor contracts/work orders and specifications to enable study objectives to be met
Reviews and approves essential document packages to enable timely site activations
Reviews pre-study, study initiation, interim monitoring visit and at study closeout visit report
Provides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates
Directs investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary
Responsible for oversight on the maintenance of the TMF and completeness at the end of the study
Perform periodic QC of the TMF
Oversee the creation and execution of clinical trial activities in accordance with Good Clinical Practices (GCP)
Ensure compliance of clinical trials with national and international regulatory requirements and co-monitoring the assigned clinical trial following company SOPs
Ensures the study is 'inspection ready' always
Responsible for oversight and coaching of the functional activities of Clinical Research Associates and Clinical Trial Associates allocated to the project
All other duties as assigned
Qualification
Required
1+ years of clinical project management experience in conducting international clinical trials in sponsor Pharma/Biotech organization
A minimum of 2+ years of phase II and III combined experience required
Strong understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process
Experience with budget forecasting and management
Ability 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 CRO
Demonstrated ability to lead teams and work in a fast-paced team environment
Demonstrated abilities to effectively delegate and manage others, as evidenced through either past people management or matrix management responsibilities
Proven track record of building relationships with KOLs and site personnel
Ability to successfully engage and work collaboratively with overseas clinical operations team members/colleagues
Demonstrated ability to build and deliver on patient enrollment strategies
Excellent interpersonal and decision-making skills. Demonstrates innovation, possesses drive, energy, and enthusiasm to deliver the program objectives
Demonstrated ability to comprehend and communicate complex scientific concepts and data
Proficient in reviewing and assessing clinical data
Possesses excellent planning, time management & 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
Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable
Strong attention to detail, accuracy and confidentiality
Must be able to effectively multi-task and manage time-sensitive and highly confidential documents
Preferred
Bachelor's degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred
Experience with clinical studies in oncology strongly preferred
Line management (direct reports) experience is preferred
Benefits
Bonus
Stock
Benefits
Other applicable variable compensation
Company
Summit Therapeutics, Inc.
Summit Mission Statement: To build a viable, long-lasting health care organization that assumes full responsibility for designing, developing, trial execution and enrollment, regulatory submission and approval, as well as successful commercialization of patient, physician, caregiver, and societal-friendly medicinal therapy intended to: improve quality of life, increase potential duration of life, and resolve serious medical healthcare needs.
201-500 employees
H1B Sponsorship
Summit Therapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (6)
2023 (1)
Funding
Current Stage
Public CompanyTotal Funding
$1.79BKey Investors
CARB-XEurofarmaBiomedical Advanced Research and Development Authority (BARDA)
2025-10-21Post Ipo Equity· $500M
2024-09-11Post Ipo Equity· $235M
2024-06-03Post Ipo Equity· $200M
Leadership Team
Manmeet Soni
Chief Operating Officer and Chief Financial Officer
Recent News
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