Summit Therapeutics, Inc.

Senior Director, Clinical Operations – Study Start-Up

Summit Therapeutics, Inc.

full-time

Posted on:

Location Type: Hybrid

Location: Menlo Park • California, Florida, New Jersey • 🇺🇸 United States

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Salary

💰 $225,000 - $280,000 per year

Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • Lead and oversee global oncology study start-up activities from site selection through site activation
  • Drive timely site activations across regions, regulatory readiness, contracts, budgets, and essential core documents
  • Collaborate with legal, finance, CRO and clinical teams to ensure site agreements comply with country regulatory and company standards
  • Partner closely with Legal counsel to ensure appropriate indemnification, liability, and confidentiality provisions are included in contracts; oversee the complex negotiation of clinical trial insurance certificates and country-specific mandates.
  • Manage and develop a team of direct reports, providing active mentorship, performance management, and career development; extend mentorship to non-direct reports within the broader Clinical Operations department to harmonize start-up best practices.
  • Build, optimize, and scale study start-up processes, SOPs, and "playbooks" suitable for a growing biotech; lead formal process improvement initiatives to reduce cycle times from site selection to activation.
  • Drive the standardization of core study documents, including global Master Informed Consent Forms (ICF), Investigator Packages, and essential document checklists to ensure consistency and speed.
  • Partner with Business Operations and IT to identify and implement technology solutions (e.g., SSU tracking modules, eTMF automation) to replace manual processes and improve data transparency.
  • Partner closely with Clinical Operations, Clinical Development, Quality, Legal, and Finance
  • Confidently present the budget to the Chief Accounting Officer and Head of Clinical Operations for approval, ensuring full knowledgeable of all details
  • Partner with Finance team to provide study-wide site payment estimates and forecasts
  • Provide regular updates to management on progress and key performance indicators related to trial agreements
  • Establish and track start-up KPIs and metrics to improve predictability and cycle times
  • Provide oversight and governance of CROs, FSP Providers and start-up vendors, including performance management and issue escalation

Requirements

  • Bachelors degree in Life Sciences, Business Administration or related field required
  • At least 12+ years of experience in managing global clinical trials
  • Proven track record of successfully managing direct reports and leading cross-functional teams through influence in a matrixed environment.
  • Demonstrated experience in process improvement and the application of technology to streamline clinical operations.
  • Deep knowledge of ICF development, clinical trial insurance requirements, protocol amendment process, and global regulatory document standards.
  • Strong negotiation and vendor management experience required
  • Experience in oncology trial management
  • Data-driven leader with expertise in start-up metrics and forecasting
  • Demonstrated successful management and oversight of CROs and other service providers
  • Ability to operate strategically while remaining hands-on and execution-focused
  • Ensure compliance with regulatory requirements, Good Clinical Practice (GCP) guidelines, and internal standard operating procedures (SOPs) throughout the study start-up phase
  • Comfortable working in fast-paced, resource-lean biotech environments
  • Experience in GrantPlan
  • Excellent communication and cross-functional leadership skills
  • Strong attention to detail with the ability to lead and function as rational and humble problem solver
  • Leadership experience with the ability to inspire excellence in themselves and those around them
  • High-quality executor; ability to execute against goals and milestones with quality, precision, and speed.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
clinical trial managementprocess improvementICF developmentprotocol amendment processregulatory document standardsvendor managementstart-up metricsforecastingGood Clinical Practice (GCP)SOPs
Soft skills
leadershipcommunicationcross-functional leadershipattention to detailproblem solvingstrategic thinkingexecution-focusedmentorshipperformance managementinfluence