Senior RBQM Lead — Risk-Based Quality Management

Summit Therapeutics; Princeton (NJ); On-site; USD 174,000 - 204,000; Full time

Job summary

Summit Therapeutics Inc. in Princeton, NJ seeks an Associate Director, Risk Based Quality Management Lead to own the RBQM program across multiple oncology clinical trials.

You will serve as the primary RBQM SME within study teams, implementing risk management, centralized monitoring, KRIs, QTLs, and risk review processes to ensure patient safety and data integrity. Collaborate with Clinical Operations, Clinical Science, Data Management and CRO partners; lead cross-functional risk workshops and

Qualifications

• Lead RBQM planning, execution and risk oversight across studies.
• Develop and maintain study RBQM Plans and CtQ factors.
• Collaborate with clinical operations, data management and CROs to mitigate risks.
• Ensure compliance with GCP, ICH guidelines and FDA regulations.
• Experience with RBQM technology and clinical analytics platforms.

Responsibilities

• Serve as RBQM Lead from protocol development through study closeout.
• Lead RBQM planning, execution and ongoing risk oversight throughout study conduct.
• Develop and maintain study-specific RBQM Plans and CtQ factors.
• Facilitate cross-functional risk workshops and create RACTs.
• Document, score, track and reassess risks and mitigation actions.
• Develop KRIs and QTLs with thresholds and escalation paths.
• Review KRI outputs and investigate threshold breaches and root causes.
• Lead RBQM reviews and present risk signals and mitigation outcomes.
• Coordinate CAPA and issue management related to RBQM findings.

Skills

RBQM Lead

Risk management

Centralized monitoring

CtQ factors

RACT

KRI/QTL tracking

Cross-functional collaboration

Education

Bachelor’s degree in life science or related field

Tools

RBQM technology

Clinical analytics platforms

Job description

Summit Therapeutics Inc. in Princeton, NJ seeks an Associate Director, Risk Based Quality Management Lead to own the RBQM program across multiple oncology clinical trials.

You will serve as the primary RBQM SME within study teams, implementing risk management, centralized monitoring, KRIs, QTLs, and risk review processes to ensure patient safety and data integrity. Collaborate with Clinical Operations, Clinical Science, Data Management and CRO partners; lead cross-functional risk workshops and