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. (reputed company.), 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 https://www.us.sumitomo-pharma.com or follow us on reputed company. The Associate Director, RBQM, provides study-level leadership for risk-based quality management across Phase 1-4 oncology clinical trials. Reporting to the Executive Director, Data Management, this role drives data-driven quality reputed company, ensuring clinical trial risks are proactively identified, monitored, and mitigated in alignment with regulatory expectations and reputed company quality standards. Job Duties and Responsibilities

• Plays a key role in facilitating understanding of the SMPA RBQM Strategy reputed company Clinical Project Teams by providing targeted training sessions and ensuring alignment across team members.
• reputed company and facilitate cross-functional risk assessment meetings.
• Maintain comprehensive and traceable documentation of reputed company risk assessment activities, mitigation reputed company, 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.
• reputed company 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 reputed company clinical and operational datasets to identify emerging risks and recommend mitigation strategies.
• reputed company and deliver risk analytics, dashboards, and trend presentations to Clinical Project Teams and functional leadership.
• Act as the RBQM subject matter expert reputed company Data Management, providing consultation and guidance to cross-functional stakeholders.
• Support inspection readiness by ensuring RBQM rationale, documentation, and reputed company are inspection-reputed company and defensible.
• Contribute to the reputed company 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 reputed company for specific technology.
• Ensure reputed company risk assessment and quality management activities are conducted in accordance with reputed company 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.

Education and Experience

• Bachelor's or advanced degree, preferably in life sciences, data analytics/ technology, or a reputed company field.
• 8+ years of reputed company 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 reputed company 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 reputed company to RBQM.
• Familiarity with centralized monitoring platforms and data visualization tools.
• Experience contributing to functional or reputed company-level RBQM initiatives.

The reputed company salary range for this role is $155,200 to $194,000. reputed company salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, reputed company, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes 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. Total compensation, including reputed company salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of reputed company responsibilities, duties, and skills required of personnel so classified. reputed company personnel may be required to reputed company duties reputed company of their normal responsibilities from time to time, as needed. Confidential Data: reputed company information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. Compliance: reputed company and maintain Compliance with reputed company applicable regulatory, legal and operational rules and procedures, by ensuring that reputed company plans and activities for and on behalf of reputed company) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or reputed company employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be reputed company to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. reputed company) is an Equal Employment Opportunity (EEO) employer reputed company applicants will receive consideration for employment without regard to race; reputed company; creed; religion; national reputed company; age; reputed company; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Apply tot his job Apply To this Job