Director, Clinical Operations Study Start-Up

About the role

The Director of Clinical Operations Study Start-Up oversees the Study Start-Up portfolio, managing study start-up activities. This role provides strategic and operational leadership for end-to-end study start-up activities across assigned clinical programs, ensuring timely, compliant, and high-quality site activation.

Responsibilities

• Provide strategic and operational leadership for end-to-end study start-up activities across assigned clinical programs, ensuring timely, compliant, and high-quality site activation.
• Leads multiple programs to ensure investigative sites are activated in accordance with the timelines set for each study.
• Accountable for development, execution, and ongoing optimization of study-specific start-up strategies, including country selection, regulatory and ethics submissions, site feasibility and selection, contract and budget execution, and site activation readiness.
• Establish and maintain clear start-up timelines, metrics, and dashboards; proactively identify risks to activation timelines and drive mitigation plans to achieve first site activation (FSI).
• Provide oversight of country- and site-level regulatory and ethics submissions (e.g., IRB/EC/HA), ensuring consistency with global strategy and local regulatory requirements.
• Monitor vendor performance and participate in Vendor Governance as needed.
• Perform proactive risk assessment to anticipate study-specific challenges and requirements and communicate in advance to the internal team to plan and mitigate risk.
• Analyze projects through the collection, tracking, and trending metrics and KPI assessments and guide internal and external teams to achieve industry-leading results for study activation.
• Ensure quality, completeness, and inspection readiness of start-up documentation, in accordance with GCP and internal SOPs.
• Partner with Clinical Research Organizations to oversee site contract and budget negotiations, ensuring alignment with approved study budgets and timely execution to support activation timelines.
• Serve as the primary escalation point for complex start-up challenges, including site readiness or performance risks, regulatory delays, or vendor issues; communicate status and resolution plans to senior leadership.
• Contribute to portfolio-level planning by providing start-up insights and recommendations to inform study design, country strategy, resourcing, and feasibility assumptions.
• Develop and maintain study start-up processes, systems, and tools to reduce cycle times, improve quality, and enhance predictability of start-up delivery.
• Ensure start-up activities are conducted in compliance with global regulations, internal policies, and company quality standards, maintaining a strong focus on patient safety and data integrity.
• Support organizational readiness for audits and inspections related to study start-up activities, partnering with Quality Assurance as needed.
• People management and development responsibilities, and may have financial accountabilities for assigned staff.
• Contribute to process improvement, development of SOPs and study start-up documents.

Requirements

• Minimum BA/BS degree or relevant graduate degree highly preferred
• Requires minimum of 15+ years of experience in the biotech/pharmaceutical industry with direct experience in feasibility, study start-up, site activation for global Phase 3 clinical trials, development of Master and country level ICFs, site payments, eTMF, CTMS, vendor oversight, and inspection readiness with a strong understanding of global regulatory requirements and clinical operations, and with over 5 years of supervisory/management experience.
• Proven track record in process improvement, clinical trial execution, and operational strategy.
• Experience with planning, management, and oversight of activities and deliverables within Clinical Operations
• Strong understanding of clinical trial management, ICH-GCP, and regulatory compliance
• Strong organizational and project management skills, with a deep understanding of regulatory and submission processes in various countries, with ability to oversee multiple studies and priorities, simultaneously.
• In-depth understanding of relevant Clinical Research, Feasibility, Study Start-Up processes and clinical operations
• Solid working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines and extensive experience with investigative site Start-Up documents
• Proven track record of managing multiple projects and/or programs concurrently.
• Excellent analytical, problem-solving, and organizational skills.
• Strong communication and interpersonal skills with the ability to influence cross-functional stakeholders.
• Demonstrated ability to lead changes and foster a culture of continuous improvement.

Qualifications

• Minimum BA/BS degree or relevant graduate degree highly preferred
• Minimum 15+ years of experience in the biotech/pharmaceutical industry with direct experience in feasibility, study start-up, site activation for global Phase 3 clinical trials, development of Master and country level ICFs, site payments, eTMF, CTMS, vendor oversight, and inspection readiness with a strong understanding of global regulatory requirements and clinical operations, and with over 5 years of supervisory/management experience.
• Proven track record in process improvement, clinical trial execution, and operational strategy.
• Experience with planning, management, and oversight of activities and deliverables within Clinical Operations
• Strong understanding of clinical trial management, ICH-GCP, and regulatory compliance
• Strong organizational and project management skills, with a deep understanding of regulatory and submission processes in various countries, with ability to oversee multiple studies and priorities, simultaneously.
• In-depth understanding of relevant Clinical Research, Feasibility, Study Start-Up processes and clinical operations
• Solid working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines and extensive experience with investigative site Start-Up documents
• Proven track record of managing multiple projects and/or programs concurrently.
• Excellent analytical, problem-solving, and organizational skills.
• Strong communication and interpersonal skills with the ability to influence cross-functional stakeholders.
• Demonstrated ability to lead changes and foster a culture of continuous improvement.

Skills

• Strategic and operational leadership
• Site activation management
• Regulatory and ethics submissions
• Vendor oversight
• Risk assessment and mitigation
• Project management
• Compliance with global regulations and ICH-GCP
• Collaboration with CROs
• Communication and interpersonal skills
• Leadership and change management

Benefits

Summit Therapeutics Inc. offers a competitive compensation package, including a salary range of $203,000 - $253,000 USD, based on qualifications and experience. Additional benefits may include bonuses, stock, benefits, and/or other applicable variable compensation.

Pay

$203,000 - $253,000 USD

Schedule

N/A

Company Information

Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including:

• Non-small Cell Lung Cancer (NSCLC)
• Colorectal Cancer (CRC)

Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.