Summit Therapeutics

Director, Clinical Operations Study Start-Up

Palo Alto, California, United States · Director

Sponsorship not specified$203k-$253kDetected 14 days ago

GCPComplianceProject ManagementProcess ImprovementRecruitingClinical TrialsClinical ResearchFDA RegulatoryResearchExperimental DesignLeadershipCommunicationCollaborationProblem Solving

About the role

The Director of Clinical Operations Study Start-Up will oversee the Study Start-Up portfolio managing Study Start-Up activities.
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.
Monitor vendor performance and participate in Vendor Governance as needed.

Responsibilities

Leads multiple programs to ensure investigative sites are activated in accordance with the timelines set for each study.
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).
Partner with Clinical Research Organization(s) to oversee site contract and budget negotiations, ensuring alignment with approved study budgets and timely execution to support activation timelines.
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.
Performs proactive risk assessment to anticipate study specific challenges and requirements and communicates in advance to the internal team to plan and mitigate risk.

Requirements

Experience with planning, management, and oversight of activities and deliverables within Clinical Operations
Strong understanding of clinical trial management, ICH-GCP, and regulatory compliance
Solid working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines and extensive experience with investigative site Start-Up documents
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.
All employment businesses/agencies are required to contact Summit's Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.

Nice to have

Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.
Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.
Minimum BA/BS degree or relevant graduate degree highly preferred

Skills

Experience, Education and Specialized Knowledge and Skills

Compensation

$203,000 - $253,000 USD
Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location.
The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.

Company info

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.

Equal opportunity

Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment.

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