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Global Clinical Operations Program Director, Late Development Oncology

US - Gaithersburg - MD💼 Full-time💰 $203,710–$203,710🗓 2026-09-17 → 2026-09-29

Core

Lead operational strategy for pivotal global Phase 3 and post-approval oncology studies, translating program objectives into business-focused plans to deliver regulator-ready evidence.

Role type

Senior IC Global Clinical Operations Program Director

Builds

Global study portfolios and clinical evidence packages for late-stage oncology medicines

Domain

Pharmaceutical industry, Oncology, Clinical Development

Required skills

Program leadership, Strategic oversight, Operational design and feasibility, Governance and business case development, Financial and resource management, Issue resolution and partner management, Submission leadership, Cross-functional delivery, People development, Change management

Preferred skills

Project management certification, Process improvement methodology (Lean Sigma/Change Management), Regulatory submission experience, Digital health initiatives in clinical studies

Technologies

PLANIT

Responsibilities

Lead cross-functional teams to plan and deliver studies within scope, quality, budget, and time; Provide strategic oversight of a program of studies; Manage clinical plans (cost, FTEs, timelines) in business reporting systems; Lead cross-functional Clinical Submission Teams to execute marketing application components; Mentor and coach staff to achieve organizational objectives.

Seniority

Senior, hands-on IC with strategic oversight

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