Summit Strategic Search
Associate Director Global Clinical Trial Operations
Summit Strategic Search, Princeton, New Jersey, us, 08543
We are partnering with a
highly respected, science-driven oncology biotechnology company
known for advancing innovative therapies through late-stage clinical development. This organization is recognized for strong scientific rigor, collaborative culture, and a deep commitment to patients. As an
Associate Director, Global Clinical Trial Operations,
you will provide end-to-end leadership for one or more global oncology clinical trials. Key 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 Qualifications:
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 Oncology drug development experience is highly desired, particularly late‑stage (Phase III) clinical trials 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 Equal Opportunity Statement
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, gender identity or expression, sexual orientation, age, marital status, veteran status, disability status, or any other characteristic protected by applicable law.
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highly respected, science-driven oncology biotechnology company
known for advancing innovative therapies through late-stage clinical development. This organization is recognized for strong scientific rigor, collaborative culture, and a deep commitment to patients. As an
Associate Director, Global Clinical Trial Operations,
you will provide end-to-end leadership for one or more global oncology clinical trials. Key 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 Qualifications:
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 Oncology drug development experience is highly desired, particularly late‑stage (Phase III) clinical trials 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 Equal Opportunity Statement
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, gender identity or expression, sexual orientation, age, marital status, veteran status, disability status, or any other characteristic protected by applicable law.
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