Associate Director, RBQM & Risk Management (Oncology)
Sumitomo Pharma America, Inc.
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Benefits offered by this job
Job summary
Sumitomo Pharma America, Inc. is seeking an RBQM subject matter expert to lead risk-based quality management across oncology trials from Phase 1 to Phase 4.
You will partner with Data Management, Biostatistics, Clinical Operations and QA to define KRIs and QTLs, develop RA/QRMP tools, run centralized monitoring, and provide leadership-ready risk analytics and dashboards for cross-functional teams. This primarily remote role requires strong communication, regulatory inspection readiness, and the
Qualifications
- 8+ years of relevant experience in biotech/pharma.
- Experience leading oncology trials across Phases 1–4.
- RBQM frameworks knowledge (RACT, QRMP) and centralized monitoring.
Responsibilities
- Lead RBQM strategy adoption in cross-functional teams.
- Define and update RACTs, QRMPs and quality parameters.
- Monitor KRIs, QTLs and centralized monitoring outputs.
- Provide risk analytics and leadership-ready presentations.
- Ensure inspection readiness and audit-ready documentation.
Skills
Education
Tools
Job description
Sumitomo Pharma America, Inc. is seeking an RBQM subject matter expert to lead risk-based quality management across oncology trials from Phase 1 to Phase 4.
You will partner with Data Management, Biostatistics, Clinical Operations and QA to define KRIs and QTLs, develop RA/QRMP tools, run centralized monitoring, and provide leadership-ready risk analytics and dashboards for cross-functional teams. This primarily remote role requires strong communication, regulatory inspection readiness, and the
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