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Job Description
Associate Director /
Director, Clinical OperationsLocation:
Hybrid - BostonWe are partnering with an innovative biotechnology company seeking an Associate Director / Director, Clinical Operations to lead and drive clinical programs from pre-IND through all phases of development (emphasis on Phase III)This role will provide strategic and operational leadership across clinical studies, partnering closely with cross-functional teams to ensure successful trial execution while supporting process improvements and operational excellence.
Key ResponsibilitiesLead and oversee global clinical studies from start-up through completionDevelop and execute clinical operational strategies alongside Clinical and Project LeadsManage study timelines, budgets, resources, vendors, and CRO relationshipsLead cross-functional collaboration across Clinical, Regulatory, Medical, Quality, Finance, and related teamsMentor and develop Clinical Operations team membersDrive study start-up activities, patient recruitment initiatives, and operational process improvementsMonitor study progress, milestones, and financial performance while ensuring compliance and inspection readinessWhat We're Looking ForBachelor's degree (or equivalent) with 8+ years of biotech/pharma experience4+ years of clinical project management experience (level determined by experience)Strong understanding of ICH, GCP, and regulatory requirementsExperience working in cross-functional matrix environmentsLife sciences or medical background requiredOncology experience preferredPrevious CRA experience highly desirableUp to 20% travel requiredIf you are a collaborative clinical operations leader looking to make a meaningful impact within a growing organization, we would like to hear from you.