Associate Director, Risk Based Quality Management, Oncology

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 or follow us on LinkedIn.
This position reports to the Executive Director, Data Management, Oncology and is part of the Data Management Oncology organization, which supports high-quality clinical trial execution through data oversight, risk identification, documentation, analytics, and cross-functional study support. The role is responsible for providing study-level leadership for Risk Based Quality Management (RBQM) across Phase 1 to Phase 4 oncology clinical trials and works closely with Clinical Operations, Data Management, Biostatistics, Clinical Project Teams, Quality, and other partner functions to ensure proactive risk assessment, centralized monitoring, mitigation planning, inspection readiness, and aligned execution of SMPA RBQM strategy.
Essential Functions Required for Job

- Facilitate understanding and adoption of the SMPA RBQM strategy within Clinical Project Teams by providing targeted training, practical guidance, and cross-functional alignment.

- Lead and facilitate cross-functional study risk assessment meetings, including planning, meeting facilitation, documentation of decisions, and follow-through on mitigation actions.

- Own the development, maintenance, and periodic update of Risk Assessment Categorization Tools (RACTs), Quality Risk Management Plans (QRMPs), and related quality parameter documentation for assigned studies.

- Ensure functional study plans align with approved risk assessments, Critical to Quality (CtQ) factors, protocol requirements, quality parameters, and data quality objectives.

- Partner with Data Management, Biostatistics, Clinical Operations, and other functional stakeholders to define, implement, monitor, interpret, and escalate key risk indicators (KRIs), quality tolerance limits (QTLs), and centralized monitoring outputs.

- Lead centralized monitoring activities, including ongoing data review, signal detection, trend analysis, documentation of findings, risk escalation, mitigation planning, and follow-through with accountable stakeholders.

- Provide expert guidance on targeted source data verification (SDV) and targeted source data review (SDR) approaches based on evolving risk profiles and study-level quality signals.

- Interpret clinical and operational datasets to identify emerging risks, quality trends, and areas requiring mitigation, escalation, or further cross-functional review.

- Develop and deliver risk analytics, dashboards, trend summaries, and leadership-ready presentations for Clinical Project Teams and functional leadership.

- Act as the RBQM subject matter expert within Data Management, providing consultation, standards interpretation, and practical guidance to cross-functional stakeholders.

- Support inspection readiness by ensuring RBQM rationale, review decisions, escalation records, mitigation documentation, and quality oversight outputs are complete, traceable, and defensible.

- Contribute to continuous improvement of RBQM processes, tools, templates, technology strategy, standards, and related SOP implementation across Data Management.

- Maintain proficiency in RBQM systems, centralized monitoring platforms, data access tools, dashboards, analytics, and applicable technology used to support risk-based oversight.

- Serve as business lead or functional representative for assigned RBQM-related technology, process improvement, or enterprise-level initiatives as needed.

- Manage direct reports, including workload planning, prioritization, coaching