Sumitomo Pharma America, Inc. · 1 day ago
Associate Director, Risk Based Quality Management, Oncology
United States
Full-time
Remote
Lead/Staff, Director/Executive
$155K/yr - $194K/yr
8+ years expSumitomo Pharma Co., Ltd. is a global pharmaceutical company focused on addressing patient needs in oncology and other therapeutic areas. The Associate Director, RBQM, provides leadership for risk-based quality management across oncology clinical trials, ensuring clinical trial risks are proactively identified and mitigated in alignment with regulatory expectations.
Pharmaceuticals
Responsibilities
Plays a key role in facilitating understanding of the SMPA RBQM Strategy within Clinical Project Teams by providing targeted training sessions and ensuring alignment across team members
Lead and facilitate cross-functional risk assessment meetings
Maintain comprehensive and traceable documentation of all risk assessment activities, mitigation decisions, and quality parameters, ensuring periodic review and updates as required
Own the development, maintenance, and ongoing updates of Risk Assessment Categorization Tools (RACT) and Quality Risk Management Plans (QRMP) for assigned studies
Ensure alignment of functional study plans with approved risk assessment and quality parameter documents
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
Partner closely with Director Clinical Operations, Oncology, including RBQM central monitoring as part of the overall monitoring strategy
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
Interpret complex clinical and operational datasets to identify emerging risks and recommend mitigation strategies
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
Contribute to the SMPA technology strategy, including serving as business lead for specific technology
Ensure all risk assessment and quality management activities are conducted in accordance with related company SOPs, including documentation, approval, and filing requirements
Manage direct line reports, providing guidance, mentorship, and performance feedback to ensure their professional growth and the successful execution of their responsibilities
Qualification
Required
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
Merit-based salary increases
Short incentive plan participation
Eligibility for our 401(k) plan
Medical, dental, vision, life and disability insurances
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
Company
Sumitomo Pharma America, Inc.
Sumitomo Pharma America (SMPA) is a science-based, technology-driven biopharmaceutical company focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need in oncology, urology, women’s health, rare disease, cell and gene therapies and CNS.
Founded in 2023Marlborough, Massachusetts, US
1001-5000 employeesH1B Sponsorship
Sumitomo Pharma America, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (9)
2023 (14)
Funding
Current Stage
Late StageLeadership Team
Adele Gulfo
Chief Executive Officer, Biopharma Commercial
Myrtle Potter
President and Chief Executive Officer, Sumitomo Pharma America
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