Director, Clinical Research

🕒 March 29

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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

• Lead, plan, and execute clinical research activities in various indications • Ownership of planning and implementation of clinical development programs • Manage project-related budgets • Oversee education of investigators and study site personnel • Participate in leading clinical study teams • Monitor overall study integrity and communicate safety and efficacy data • Responsible for SAB and DSMB relationships • Present at program-related scientific, medical, and regulatory meetings • Develop and maintain relationships with academic investigators and pharmaceutical partners • Contribute to regulatory filings including authoring clinical sections • Partner with Drug Safety & Pharmacovigilance • Maintain high level of clinical awareness in disease area • Co-author manuscripts and collaborate with colleagues

🎯 Requirements

• 10+ years of pharmaceutical clinical research experience • Additional experience in an academic setting advantageous • Experience executing global, multi-center, complex clinical research programs with minimal direction • Deep knowledge of clinical trial methodology, regulatory and compliance requirements • Proven leadership skills and ability to bring out the best in others • Experience authoring and reviewing global regulatory submissions • Experience with multiple therapeutic modalities • Experience with Phase 4 clinical studies • Experience and strength in data management advantageous • Experience in Women’s Health preferred; CNS, Rare Disease experience beneficial • Excellent communication and presentation skills essential • Advanced degree in life sciences, clinical pharmacology, or related discipline • Clinical research certification or regulatory knowledge beneficial • Professional English proficiency required; additional languages beneficial

🏖️ Benefits

• Merit-based salary increases • Short incentive plan participation • Eligibility for 401(k) plan • Medical, dental, vision, life and disability insurances • Flexible paid time off • 11 paid holidays plus additional time off during shutdown period • 80 hours of paid sick time upon hire and each year thereafter