Clinical Trials Management Director

🕒 Abril 9

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Sumitomo Pharma America, Inc.

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1001 - 5000 funcionários

🧬 Biotecnologia

💊 Farmacêutico

⚕️ Seguro de Saúde

Biotechnology • Pharmaceuticals • Healthcare Insurance

A Sumitomo Pharma America, Inc. é dedicada a melhorar a saúde e o bem-estar de pessoas ao redor do mundo, impulsionando tratamentos inovadores, ciência e tecnologia. A empresa concentra-se em atender às necessidades dos pacientes em áreas críticas como psiquiatria e neurologia, oncologia, urologia, saúde da mulher, doenças raras e terapia celular e genética. Como uma subsidiária da Sumitomo Pharma Co. , Ltd. , a SMPA incorpora a promessa de combinar tecnologia e expertise em ciências da vida para melhorar os resultados dos pacientes. Com um pipeline diversificado de programas pré-clínicos e clínicos, a SMPA está comprometida em oferecer soluções centradas no paciente por meio de uma abordagem orientada pela tecnologia.

Descrição

• Direct the end-to-end planning, execution, monitoring, and successful completion of one or more clinical studies within a program(s). • Oversee the development and control of key study documents and plans (e.g., protocols, informed consents, clinical study reports). • Oversee Trial Master File (TMF) set-up, maintenance, and completeness to ensure inspection readiness. • Collaborate with relevant functions to support data completeness and accurate reporting. • Proactively identify, manage, and mitigate study/program risks and issues. • Lead quality and compliance activities with cross-functional teams and vendors to drive continuous improvement. • Develop, manage, and refine budgets, forecasts, and financial reporting for the assigned program(s). • Serve as the clinical operations' functional representative on cross-functional program teams. • Provide oversight in the selection, onboarding, training, and performance management of study personnel, CROs, and other vendors.

🎯 Requisitos

• Bachelor’s or advanced degree, preferably in life sciences, pharmacy, or a related field. • Minimum 10–15 years (without Master’s) or 8–12 years (with Master’s) of relevant experience in biotech/pharmaceutical or CRO setting, with experience supporting Phases 1–4 clinical studies. • Experience managing global patient population studies. • Therapeutic experience working with stem cells and regenerative medicine. • Strong phase 1/2 experience.

🏖️ Benefícios

• merit-based salary increases • short incentive plan participation • eligibility for 401(k) plan • medical, dental, vision, life and disability insurances • leaves provided in line with your work state • flexible paid time off • 11 paid holidays plus additional time off for a shut-down period during the last week of December • 80 hours of paid sick time upon hire and each year thereafter