Associate Director Global Clinical Trial Operations jobs in United States
cer-icon
Apply on Employer Site
company-logo

Summit Strategic Search · 5 days ago

Associate Director Global Clinical Trial Operations

Summit Strategic Search is partnering with a highly respected, science-driven oncology biotechnology company known for advancing innovative therapies through late-stage clinical development. As an Associate Director, Global Clinical Trial Operations, you will provide end-to-end leadership for one or more global oncology clinical trials, coordinating cross-functional teams and overseeing trial execution from protocol development to completion.

Staffing & Recruiting

Responsibilities

Lead and coordinate global, cross-functional clinical trial teams including Clinical Operations, Medical, Biostatistics, Data Management, Programming, and external partners
Own end-to-end execution of global clinical trials from protocol development and study start-up through database lock and Clinical Study Report (CSR) completion
Serve as the primary sponsor counterpart to CROs and vendors, overseeing performance, deliverables, timelines, and quality
Develop, manage, and maintain integrated study timelines, budgets, forecasts, and risk mitigation plans
Support country and site strategy including feasibility, start-up planning, regulatory and ethics committee interactions
Review and approve key trial documentation including protocols, amendments, operational plans, and study manuals
Proactively identify study risks and issues, implement mitigation strategies, and escalate as appropriate
Provide regular trial updates to senior leadership and contribute to broader clinical development discussions
Support inspection readiness, audits, and implementation of corrective and preventive actions
Mentor and support team members while fostering a culture of collaboration, accountability, and continuous improvement

Qualification

Global clinical trial leadershipICH-GCP knowledgeOncology drug developmentCRO managementTrial planningStakeholder managementCommunication skillsCollaboration skills

Required

Significant experience leading global clinical trials within a pharmaceutical or biotechnology environment
Strong working knowledge of ICH-GCP, global clinical trial processes, and regulatory requirements
Demonstrated ability to lead matrixed, cross-functional teams and influence without direct authority
Experience managing CROs, vendors, and outsourced partners in a global setting
Proven strengths in trial planning, budget management, and execution
Excellent communication, collaboration, and stakeholder management skills
Strong commitment to high-quality clinical research and patient-focused development

Preferred

Oncology drug development experience is highly desired, particularly late-stage (Phase III) clinical trials

Company

Summit Strategic Search

twitter
company-logo
At Summit Strategic Search, we’re redefining what it means to be a true recruitment partner in the pharmaceutical and life sciences industries.

Funding

Current Stage
Early Stage
Company data provided by crunchbase