Senior RBQM Lead, Risk-Based Quality Management

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

Job summary

Summit Therapeutics, Inc. is seeking an Associate Director/RBQM Lead to drive operational RBQM across multiple clinical studies.

You will serve as the RBQM SME, leading risk management, centralized monitoring, KRIs, QTLs and CtQ factors, collaborating with Clinical Operations, Data Management and CROs. Responsibilities include planning risk assessments, developing RBQM plans, monitoring data quality, and ensuring adherence to GCP/ICH guidelines throughout the lifecycle.

Qualifications

• Bachelor’s degree or equivalent in life science or health/medical-related fields.
• 10+ years of clinical operations experience in sponsor/pharma or biotech.
• 7+ years in RBQM, centralized monitoring, or study management.

Responsibilities

• Lead RBQM planning, execution, and ongoing risk oversight across studies.
• Develop and maintain study RBQM plans and CtQ factors.
• Facilitate risk assessments and maintain RACTs.
• Develop and manage KRIs and QTLs; present at governance meetings.
• Oversee centralized monitoring across trials and CRO partnerships.
• Ensure RBQM activities comply with GCP, ICH guidelines, and FDA regulations.

Skills

RBQM

Central Monitoring

KRI

QTL

Risk Assessment

Regulatory Knowledge

Communication

Stakeholder management

Education

Bachelor’s degree or equivalent in life science or health/medical

Tools

RBQM technology

Clinical analytics platforms

Job description

Summit Therapeutics, Inc. is seeking an Associate Director/RBQM Lead to drive operational RBQM across multiple clinical studies.

You will serve as the RBQM SME, leading risk management, centralized monitoring, KRIs, QTLs and CtQ factors, collaborating with Clinical Operations, Data Management and CROs. Responsibilities include planning risk assessments, developing RBQM plans, monitoring data quality, and ensuring adherence to GCP/ICH guidelines throughout the lifecycle.