Senior Director, Clinical Trials Management

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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

• Responsible for directing the planning, execution, monitoring, and successful completion of clinical studies within the vaccine program • Develop and oversee study documents and plans • Review trial data for completeness and accuracy • Collaborate with cross-functional teams on quality and compliance activities • Develop, manage, and refine budgets for the assigned program • Serve as the functional representative on cross-functional teams • Provide subject matter expertise on department initiatives • Oversee selection, training, and management of study personnel and vendors • Manage direct line reports, providing guidance and performance feedback

🎯 Requirements

• Bachelor's or advanced degree, preferably in life sciences, pharmacy, or a related field • Minimum 15+ years (w/o Master’s) or 10+ years (with Master’s) of relevant experience in biotech or pharmaceutical industry • Preferred minimum 5 years direct experience in clinical trial management of vaccine programs • Extensive knowledge of clinical development principles and concepts • Familiarity with the lifecycle of a clinical trial • Current on industry standards and trends • Excellent written and oral communication skills in English • Ability to communicate in medical and scientific terms in English • Ability to read, analyze and interpret professional journals and government regulations in English • Ability to write reports and business correspondence in English • Ability to effectively present information to management and sites

🏖️ Benefits

• Merit-based salary increases • Short incentive plan participation • Eligibility for 401(k) plan • Medical insurance • Dental insurance • Vision insurance • Life insurance • Disability insurance • Flexible paid time off • 11 paid holidays • Paid sick time upon hire