Associate Director, Risk-Based Quality Management in Oncology Clinical Trials

Join Sumitomo Pharma Co., Ltd., a global leader in the pharmaceutical industry, dedicated to advancing innovative solutions in oncology, urology, women's health, rare diseases, and more. We are committed to accelerating research and development to bring essential therapies to patients in need.

The Associate Director for Risk-Based Quality Management will provide decisive leadership for risk management across Phase 1-4 oncology clinical trials. Reporting directly to the Executive Director of Data Management, this role focuses on proactive oversight and ensuring alignment with regulatory standards and our company's quality benchmarks.

Key Responsibilities:

• Facilitate the understanding of the RBQM Strategy within Clinical Project Teams through targeted training and team alignment.
• Lead cross-functional risk assessment meetings to identify and mitigate potential risks effectively.
• Maintain thorough documentation of all risk assessment activities, ensuring regular reviews and necessary updates.
• Own the development and upkeep of Risk Assessment Categorization Tools and Quality Risk Management Plans for assigned studies.
• Work to ensure that all study plans align with risk assessments and quality expectations.
• Ensure alignment of study risks with Critical to Quality factors, protocol requirements, and data quality objectives.
• Collaborate closely with Data Management and Biostatistics to define and monitor Key Risk Indicators and Quality Tolerance Limits.
• Partner with the Director of Clinical Operations, Oncology, on centralized monitoring as part of the overall strategy.
• Lead the execution of centralized monitoring strategies, including ongoing data review and trend analysis.
• Provide expert guidance on targeted Source Data Verification and Source Data Review based on evolving risk profiles.
• Analyze complex clinical data to identify risks and develop strategic mitigation plans.
• Create and present risk analytics, dashboards, and trend insights to Clinical Project Teams and leadership.
• Act as the RBQM expert within Data Management, offering guidance to stakeholders across functions.
• Ensure all RBQM documentation is inspection-ready and meets regulatory compliance standards.
• Contribute to the ongoing improvement of RBQM processes and tools.
• Maintain expertise in relevant technologies that support RBQM analytics and data access.
• Ensure adherence to SOPs for risk assessment and quality management activities.
• Manage and mentor direct reports, supporting their professional growth and effective execution of responsibilities.

Qualifications:

• Bachelor's or advanced degree in life sciences, data analytics or a related field.
• 8+ years of experience in clinical development, data management, or quality management within RBQM.
• Proven experience in managing oncology clinical trials across all phases.
• Hands-on experience with TransCelerate RBQM frameworks, including ownership of Risk Assessment and Quality Risk Management tools.
• Strong ability to lead risk assessments and influence teams across functional areas without direct authority.
• Practical experience in implementing centralized monitoring and risk-based strategies.
• Proven success in a matrixed, global work environment.
• Experience in handling regulatory inspections and audits related to RBQM.
• Familiarity with centralized monitoring platforms and data visualization technologies.
• Experience in contributing to RBQM initiatives at various levels.

The base salary range for this role is $155,200 to $194,000, accompanied by a comprehensive rewards package including merit-based salary increases, participation in short incentive plans, a 401(k) plan, medical, dental, vision, life and disability insurance, and generous leave policies. Total compensation will reflect each candidate's unique experiences and qualifications.

Disclaimer: This description is intended to convey a general understanding of the responsibilities and scope of the role. Specific duties may vary as needed.

Compliance: Ensure compliance with all applicable regulatory standards and ethical practices throughout the organization.

Sumitomo Pharma America is dedicated to equal employment opportunities and fosters a diverse work environment.