"Alerted.org

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 https://www.us.sumitomo-pharma.com or follow us on LinkedIn.

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 oversight, ensuring clinical trial risks are proactively identified, monitored, and mitigated in alignment with regulatory expectations and Sumitomo Pharma America quality standards.

Job Duties and 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.

Education and Experience

+ 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.

The base salary range for this role is $155,200 to $194,000. Base 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, vision, 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 base 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 all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

**Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.

**Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) 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 continued 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 able 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.

Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer

Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; 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.

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 https://www.us.sumitomo-pharma.com or follow us on LinkedIn.

Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at [email protected]

This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.

At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company’s cultural pillars.

Our** **Mission

_To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_

Our** **Vision

_For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_