Associate Director, Study Start-up, Oncology

Sumitomo Pharma • Marlborough, MA

10d

About The Position

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. The Associate Director, Study Start-up (SSU), Oncology is accountable for the end-to-end delivery of site start-up activities across clinical studies, from site identification through site activation. This role works in close collaboration with the Clinical Project Manager (CPM) and/or Clinical Operations Study Lead and serves as an active member of one or more study teams. The Associate Director leads the strategy development and execution of global site identification, feasibility, and selection for new and ongoing oncology trials. This position requires close collaboration with cross-functional stakeholders and external vendors involved in site selection and activation processes. The role also includes line management responsibilities for the Clinical Operations Study Start-up team, with accountability for team performance, capability development, and compliance with applicable SOPs and regulatory requirements.

Requirements

• Minimum of 8 years of experience in clinical drug development, clinical program management, or equivalent academic experience in clinical trials.
• Bachelor’s degree in a related discipline (preferably life sciences) or an equivalent combination of education and experience.
• Comprehensive knowledge of ICH-GCP and international clinical trial regulations; working knowledge of GMP/GDP principles.
• Thorough understanding of oncology clinical research and operational considerations.
• Working knowledge of current global regulatory requirements and guidelines governing clinical trials.
• Strong leadership, collaboration, and people management skills, with experience building and leading high-performing teams.
• Excellent negotiation, communication, and interpersonal skills, with the ability to work effectively with internal and external stakeholders, including investigators, site staff, CROs, vendors, and global parent-company partners.
• Demonstrated ability to manage multiple priorities and competing deadlines in a fast-paced environment.
• Proven experience facilitating cross-functional meetings, driving alignment, and supporting informed decision-making.
• Strong attention to detail, organizational skills, and the ability to establish priorities and meet timelines.
• Sound judgment, problem-solving capability, and a data-driven approach to planning, execution, and risk management.

Responsibilities

• Collaborate with CPMs, Clinical Business Operations, Clinical Development, Medical Affairs, CROs, and other functional stakeholders to ensure site activation activities are completed efficiently and in accordance with study timelines and local requirements.
• Lead and manage the development and maintenance of study-specific site activation plans across countries and sites.
• Proactively identify risks, issues, and delays related to start-up activities and implement mitigation strategies.
• Review, optimize, and continuously improve study start-up processes to ensure quality, efficiency, and compliance.
• Provide oversight and support for regulatory submissions and approvals across multiple countries.
• Ensure collection and filing of essential documents in compliance with ICH-GCP and company SOPs.
• Support site budget and contract negotiations and execution in collaboration with cross-functional partners.
• Oversee preparation and execution of CDAs, site contracts, and ICFs.
• Track and communicate site start-up metrics and activation progress.
• Lead implementation and effective use of clinical systems supporting site start-up.
• Leverage clinical systems to predict enrollment, site performance and diversity enrollment track record.

Benefits

• opportunity for merit-based salary increases
• short incentive plan participation
• eligibility for our 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level