Summit Therapeutics, Inc.
Summit Therapeutics, Inc.
201 – 500 Employees
ConsultingHealthcareMarketing
Summit Therapeutics, Inc. is a biopharmaceutical oncology company developing and commercializing medicines for serious unmet medical needs. Its lead program, ivonescimab (SMT112), is a bispecific antibody targeting PD-1 and VEGF that is being evaluated in Phase 3 clinical trials for non-small cell lung cancer and other solid tumors under license from Akeso. The company’s work spans clinical development, regulatory strategy, and potential commercialization in its licensed territories, with a focus on treatments designed to support patients and caregivers.

Director of Clinical Study Start-Up (United States Remote)

Lead site-agreement strategy, budgeting, negotiations, and payment forecasting for Summit Therapeutics’ global oncology trials. Drive compliant, efficient clinical-site activation and vendor coordination across study programs.

Description

  • Develop site-budget pricing strategies that support contract execution and clinical-site activation
  • Partner with Legal, Finance, CROs, and clinical teams to ensure site agreements meet regulatory and company standards
  • Negotiate and execute site agreements, including budgets, contracts, and supporting documentation
  • Review budgets to achieve favorable pricing
  • Present proposed budgets to the Chief Accounting Officer for approval
  • Prepare study-wide site-payment estimates and forecasts with Clinical Finance
  • Coordinate with legal counsel on indemnification, liability, and confidentiality terms
  • Report progress and trial-agreement KPIs to management
  • Resolve budget, invoice, payment, and purchase-order matters with Finance and Clinical Leadership
  • Coordinate with external FSP providers on budget templates, work orders, purchase orders, and site-payment processes
  • Build effective working relationships with CROs, FSP providers, and clinical sites
  • Track FSP providers’ timelines, quality standards, and contractual commitments
  • Establish and implement departmental processes and standards
  • Support senior management on special projects
  • Create and maintain clinical-trial outsourcing strategies across development phases
  • Deliver timely, cost-effective solutions within approved timelines and budgets
  • Resolve site-agreement issues and disputes
  • Work cross-functionally with Legal, Clinical Operations, and Clinical Development
  • Design and implement process-efficiency improvements
  • Complete other assigned responsibilities

Requirements

  • Bachelor’s degree in Life Sciences, Business Administration, or a related discipline is required
  • At least 10 years of experience managing clinical-trial site agreements in a biotechnology or pharmaceutical environment
  • Oncology experience is highly desirable
  • Demonstrated strength in global negotiation and contract management
  • Experience in clinical finance, business development, or clinical operations
  • Strong financial judgment with the ability to understand and develop budgets
  • Experience managing global site budgets and navigating potential internal escalation pathways
  • Strong working knowledge of grant plans
  • Experience supporting large, multisite clinical trials involving multiple vendor types
  • Experience working with departments that have established processes
  • Direct experience evaluating and negotiating with clinical sites and vendors
  • Sound understanding of clinical-trial processes
  • Proficiency with standard Microsoft Office applications, including Word and Excel; experience with electronic document-management and document-review systems is desirable
  • Strong computer and database skills
  • High level of attention to detail, accuracy, and confidentiality
  • Clear, concise verbal and written communication skills
  • Excellent communication, interpersonal, and organizational abilities
  • Critical-thinking and problem-solving skills, with the ability to work independently
  • Ability to manage multiple priorities and time-sensitive, highly confidential documents effectively
  • Ability to explain complex ideas clearly and understandably
  • Ability to prioritize competing demands
  • Ability to succeed in a fast-paced, demanding, collaborative environment
  • Knowledge of Good Clinical Practice guidelines and applicable regulatory requirements

Benefits

  • The total compensation package may include a bonus, equity, benefits, and/or other applicable variable compensation
  • Summit Therapeutics, Inc. is an Equal Opportunity Employer

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