Associate Director, Risk Based Quality Management, Oncology
Sumitomo Pharma America, Inc.
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $155,200 - $194,000 per year
Job Level
About the role
- Provide study-level leadership for risk-based quality management across Phase 1–4 oncology clinical trials
- Drive data-driven quality oversight, ensuring clinical trial risks are proactively identified, monitored, and mitigated
- Facilitate understanding of the SMPA RBQM Strategy within Clinical Project Teams by providing targeted training sessions
- Lead and facilitate cross-functional risk assessment meetings
- Maintain comprehensive and traceable documentation of all risk assessment activities
- Own the development, maintenance, and ongoing updates of Risk Assessment Categorization Tools (RACT) and Quality Risk Management Plans (QRMP)
- Ensure alignment of study risks with Critical to Quality (CtQ) factors, protocol requirements, and data quality objectives
- Partner closely with Data Management and Biostatistics to define, implement, and monitor KRIs and QTLs
- Lead the execution of centralized monitoring strategies, including ongoing data review, signal detection, and trend analysis
- Provide expert guidance on targeted SDV and targeted SDR approaches based on evolving risk profiles
- Develop and deliver risk analytics, dashboards, and trend presentations to Clinical Project Teams and functional leadership
- Act as the RBQM subject matter expert within Data Management, providing consultation and guidance to cross-functional stakeholders
- Support inspection readiness by ensuring RBQM rationale, documentation, and decisions are inspection-ready and defensible
- Contribute to the continuous improvement of RBQM processes, tools, and standards across Data Management
- Maintain high proficiency in systems and technology as applicable to RBQM monitoring analytics and data access
- Manage direct line reports, providing guidance, mentorship, and performance feedback
Requirements
- Bachelor's or advanced degree, preferably in life sciences, data analytics/technology, or a related field
- 8+ years of progressive experience in clinical development, data management, clinical quality, or RBQM
- Demonstrated experience supporting or leading oncology clinical trials across Phase 1–4
- Hands-on experience with TransCelerate RBQM frameworks, including RACT and QRMP ownership
- Proven ability to lead risk assessments and influence cross-functional teams without direct authority
- Experience implementing centralized monitoring, KRIs, QTLs, and risk-based SDV/SDR strategies
- Experience operating effectively in a matrixed, global environment
- Experience supporting regulatory inspections or audits related to RBQM
- Familiarity with centralized monitoring platforms and data visualization tools
- Experience contributing to functional or enterprise-level RBQM initiatives
Benefits
- medical, dental, vision, life and disability insurances
- 401(k) plan
- short incentive plan participation
- flexible paid time off
- 11 paid holidays
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
risk-based quality managementdata analyticsrisk assessmentcentralized monitoringdata reviewsignal detectiontrend analysisrisk analyticsdata visualizationTransCelerate RBQM frameworks
Soft skills
leadershipmentorshipcommunicationinfluencecollaborationtrainingguidanceperformance feedbackproblem-solvingcontinuous improvement