Manager, Clinical Study Start Up jobs in United States
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Summit Therapeutics, Inc. · 1 day ago

Manager, Clinical Study Start Up

positionMenlo Park, CA
timeFull-time
remoteOnsite
seniorityMid Level
money$118K/yr - $139K/yr
date4+ years exp

Summit Therapeutics, Inc. is a biotechnology company focused on developing innovative therapies, including their investigational bispecific antibody, Ivonescimab. The Manager, Clinical Study Start Up will be responsible for managing site agreements, negotiating contracts, and collaborating with various teams to support clinical trial operations.

BiotechnologyHealth CareMedical DeviceTherapeutics
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H1B Sponsor Likelynote

Responsibilities

Under minimal guidance, develop pricing strategies for site budgets to enable contract execution and site activation
Collaborate with legal, finance, CRO and clinical teams to ensure site agreements comply with regulatory and company standards
Negotiate and finalize site agreements, including budgets, contracts, and other necessary documentation. Knowledge of CTA legal risks and possible fallback language required
Rigorous analysis of budgets with the goal of securing the best price
Confidently present the budget to the Chief Accounting Officer for approval, ensuring full knowledge of all details
Partner with Clinical Finance team to provide study-wide site payment estimates and forecasts
Work with legal counsel to ensure appropriate indemnification, liability, and confidentiality provisions are included in contracts
Provide regular updates to study management on progress and key performance indicators related to trial agreements
Work with Finance and Clinical Leadership as needed to address budget, invoice, payment, and PO concerns
Collaborate with external functional service providers (FSP) on site budget templates, study-level work orders and POs, and site payment processes
Build and maintain strong relationships with CROs, FSP providers, and clinical sites
Monitor FSP providers and ensure adherence to project timelines, quality standards, and contractual obligations
Ensure timely and cost-effective solutions that meet project timelines and budgets
Address and resolve any issues or disputes related to site agreements
Collaborate with internal stakeholders, such as Legal, Clinical Operations and Clinical Development
Develop and implement innovative ideas and solutions to increase the efficiency of the department
All other duties as assigned

Qualification

Clinical trial agreementsContract negotiationBudget managementOncology experienceClinical operationsFinancial acumenGCP guidelines knowledgeMS Office proficiencyInterpersonal skillsCritical thinkingAttention to detail

Required

Bachelor's degree in Life Sciences, Business Administration or related field required
A minimum of 4+ years' experience with clinical trial site agreements in biotech or pharmaceutical setting
Strong global negotiation and contract management skills
Experience in clinical operations and/or study start up
Strong financial acumen and ability to understand and create budgets
Experience working with site budgets on a global scale, and potential internal escalation pathway
Strong knowledge of using grant plan or similar benchmarking tool
Direct negotiating with sites and vendors is a must
Good understanding of the clinical process is important
Strong computer and database skills
Attention to detail, accuracy, and confidentiality
Clear and concise oral and written communication skills
Excellent communication, interpersonal and organizational skills
Critical thinking, problem solving, ability to work independently
Must be able to effectively multi-task and manage time-sensitive and highly confidential documents
Prioritize conflicting demands
Work in a fast-paced, demanding, and collaborative environment
Knowledge of GCP guidelines and relevant regulatory requirements

Preferred

Experience in oncology is highly desirable
Expertise in large, multi-site, clinical trials with multiple vendor types is preferred
Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable

Benefits

Bonus
Stock
Benefits
Other applicable variable compensation

Company

Summit Therapeutics, Inc.

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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.
dateFounded in 2003
location
Abingdon, Oxfordshire, GBR
people-size201-500 employees
web-link
https://www.smmttx.com/

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 Company
Total Funding
$1.79B
Key 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

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Manmeet Soni
Chief Operating Officer and Board Member
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Recent News

prnasia.com
Significant Improvement in Quality of Life Reported in Updated HARMONi-6 Data for Ivonescimab at ESMO Asia
2025-12-09
Benzinga.com
Russell 2000 Hits Record Highs, Silver Rallies To $60: What's Moving Markets Tuesday?
2025-12-09
The Motley Fool
Trading Near Its 52-Week Low, Is Summit Therapeutics a Good Stock to Buy Right Now?
2025-12-05
Company data provided by crunchbase