Clinical Trials Management Director

🕒 April 9

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Sumitomo Pharma America, Inc.

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Sumitomo Pharma America, Inc. is dedicated to improving the health and well-being of people around the world by driving innovative treatments, science, and technology. The company focuses on addressing patient needs in critical areas such as psychiatry & neurology, oncology, urology, women's health, rare diseases, and cell & gene therapy. As a subsidiary of Sumitomo Pharma Co. , Ltd. , SMPA embodies the promise of combining technology and life-sciences expertise to improve patient outcomes. With a diverse pipeline of preclinical and clinical programs, SMPA is committed to delivering patient-first solutions through a technology-driven approach.

📋 Description

• 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.

🎯 Requirements

• 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.

🏖️ Benefits

• 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