Job Overview
Location
US-Remote
Job Type
Full-time
Category
Other
Date Posted
April 8, 2026
Full Job Description
đź“‹ Description
- • The Clinical Trials Management Director leads the end-to-end planning, execution, monitoring, and successful completion of clinical studies within assigned programs, ensuring adherence to timelines, budgets, and quality standards while driving patient-focused innovation in oncology, urology, women’s health, rare diseases, cell & gene therapies, and CNS.
- • Day-to-day responsibilities include overseeing study document development and control (protocols, informed consents, clinical study reports), managing Trial Master File (TMF) setup and maintenance for inspection readiness, identifying and mitigating study/program risks, managing budgets and financial reporting, and serving as the clinical operations representative on cross-functional teams.
- • Sumitomo Pharma Co., Ltd. is a global pharmaceutical company headquartered in Japan with U.S. operations (Sumitomo Pharma America, Inc.) dedicated to accelerating discovery and development of novel therapies across multiple therapeutic areas, with several marketed products and a diverse pipeline of early- to late-stage investigational assets.
- • In this role, the individual will develop deep expertise in global clinical trial leadership, regulatory compliance (GCP/ICH), cross-functional influence, vendor and team management, and process improvement—gaining the ability to shape clinical operations strategy and contribute to bringing life-changing therapies to patients faster.
🎯 Requirements
- • Bachelor’s or advanced degree in life sciences, pharmacy, or a related field
- • Minimum 8–15 years of relevant experience in biotech/pharmaceutical or CRO settings, including experience supporting Phases 1–4 clinical studies
- • Proven experience as a clinical operations lead with end-to-end oversight of clinical trial lifecycle
- • Strong understanding of GCP, ICH guidelines, and regulatory requirements for clinical studies
- • Demonstrated ability to manage multiple vendors, CROs, and cross-functional global teams through influence and coaching
- • Excellent written and oral communication skills, with ability to translate scientific/medical concepts for diverse stakeholders
🏖️ Benefits
- • Competitive base salary range of $195,500.00 – $244,400.00
- • Eligibility for merit-based salary increases and short-term incentive plan participation
- • Access to 401(k) retirement plan with company match
- • Comprehensive medical, dental, vision, life, and disability insurance coverage
- • Generous time-off policy including flexible PTO, 11 paid holidays, year-end shutdown period, and 80 hours of paid sick time annually
- • Opportunity to work remotely with periodic on-site meetings and domestic/international travel as needed
Skills & Technologies
About Sumitomo Pharma Co., Ltd.
Sumitomo Pharma Co., Ltd. is a Japanese pharmaceutical company engaged in the research, development, manufacture, and sale of prescription drugs, diagnostics, and over-the-counter products. Its therapeutic focus spans psychiatry, neurology, oncology, urology, cardiovascular, and metabolic disorders. Established in 1984 as Sumitomo Pharmaceuticals and headquartered in Osaka, it became a consolidated subsidiary of Sumitomo Chemical before merging with Dainippon Pharma in 2005 to create Dainippon Sumitomo Pharma. In 2022 the company rebranded to Sumitomo Pharma, continuing to leverage global R&D alliances and innovative pipelines to address unmet medical needs and improve quality of life worldwide.
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