Associate Director, Risk Based Quality Management Lead
Princeton, New Jersey, United States · On-site
$174k–$204k/yr
Senior+$1.8B raised
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Associate Director, Risk Based Quality Management Lead
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$174k–$204k/yr
Full-time
bachelor degree
Bonus, Stock, Health Insurance
Posted 18d ago
~40 hrs/week
Responsibilities
The RBQM Lead is responsible for the operational execution of risk-based quality management activities across clinical studies, including risk identification, mitigation, and centralized monitoring. They collaborate with cross-functional teams to ensure participant safety, data reliability, and regulatory compliance throughout the clinical trial lifecycle.
Requirements
Candidates must have at least 10 years of clinical operations experience and 7 years of direct experience in RBQM, centralized monitoring, or clinical quality management. A bachelor's degree in a life science or health-related field is preferred, along with deep knowledge of GCP and ICH guidelines.
Full job description
About Summit:
Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.
Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including:
Non-small Cell Lung Cancer (NSCLC)
HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.
HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.
HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.
Colorectal Cancer (CRC)
HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.
Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.
Overview of Role:
The Associate Director, Risk-Based Quality Management (RBQM Lead) is accountable for the operational execution of RBQM activities across assigned clinical studies. Serving as the primary RBQM subject matter expert within study teams, this role implements and maintains study-level risk management, centralized monitoring, Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), targeted monitoring strategies, and risk review processes.
Working closely with Clinical Operations, Clinical Science, Data Management, Biostatistics, Medical Monitoring, and CRO partners, the RBQM Lead proactively identifies, evaluates, escalates, and mitigates risks throughout the clinical trial lifecycle to support participant safety, data reliability, and regulatory compliance.
Role and Responsibilities:
Study-Level RBQM Execution
Serve as the RBQM Lead and core study team member 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 Critical-to-Quality (CtQ) factors, ensuring alignment with protocol objectives and identified study risks.
Risk Assessment & Risk Management
Facilitate cross-functional risk identification and assessment workshops and lead creation and maintenance of study Risk Assessment and Categorization Tools (RACTs).
Document, score, track, and periodically reassess risks, identifying new or emerging risks from study performance data and operational signals.
Collaborate with study teams to implement risk mitigation strategies and actions, monitor their effectiveness, and recommend additional interventions when needed.
Key Risk Indicator (KRI) Management
Develop and maintain study-specific KRIs linked to identified risks and CtQ factors, including thresholds, triggers, and escalation pathways.
Review and interpret KRI outputs and investigate threshold breaches and root causes.
Facilitate study-team RBQM reviews and track KRI trends, actions, and mitigation outcomes.
Quality Tolerance Limit (QTL) Oversight
Collaborate with study teams to establish protocol-specific QTLs
Monitor QTL performance throughout study conduct.
Investigate QTL excursions and assess potential impact on participant safety and data integrity.
Coordinate documentation of investigations, assessments, and corrective actions.
Present QTL findings during study governance reviews.
Central Monitoring:
Lead the implementation of centralized monitoring strategies across multiple clinical trials
Monitor and review clinical trial data across sites to ensure accuracy, completeness, and
consistency with study protocols.
Conduct routine centralized monitoring reviews, through performing real-time data surveillance to identify outliers, trends, and potential issues that could impact data integrity.
Analyze data visualizations, listings, dashboards, and statistical outputs.
Identify unusual data patterns, quality concerns, and site-specific risks.
Evaluate trends across subjects, sites, countries, and regions.
Assess effectiveness of ongoing monitoring activities.
Generate risk summaries and recommendations for study teams.
Partner with Clinical Operations, CRO teams, CRAs, Data Management, Medical Monitoring, and other stakeholders to develop and implement site-specific action plans.
Monitor the effectiveness of interventions at high-risk sites and escalate persistent quality concerns.
Issue Management & CAPA Support
Support investigations of significant quality events and compliance issues, including root cause analyses.
Contribute to the definition of corrective and preventive actions (CAPAs) and quality improvement plans and monitor the effectiveness of proposed actions throughout the conduct of the study.
Inspection Readiness
Maintain inspection-ready documentation of risk assessments, KRI and QTL reviews, centralized monitoring activities, findings, corrective actions, and recommendations.
Support sponsor audits, regulatory inspections, and quality-control checks, including preparation of RBQM-related responses and data-review reports.
Prepare monitoring reports summarizing findings, trends, and recommendations for improvements to the study team in support of the preparation for internal and regulatory audits
Ensure RBQM activities comply with GCP, ICH guidelines, FDA regulations, and other applicable regulatory requirements.
Participate in internal quality assurance activities and continuous improvement initiatives.
Experience, Education and Specialized Knowledge and Skills:
Bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical-related areas preferred.
10+ years of clinical operations experience in sponsor pharmaceutical or biotechnology organizations.
7+ years of direct RBQM, centralized monitoring, risk-based monitoring, clinical quality, or study management experience.
Experience supporting global Phase II and/or Phase III clinical trials.
Experience conducting risk assessments; developing and managing KRIs and QTLs; and facilitating risk review meetings.
Demonstrated ability to interpret complex scientific, clinical, and operational data to identify quality and compliance risks and support centralized trial monitoring.
Experience working with CROs, RBQM technology and clinical analytics platforms.
Proven ability to oversee large, complex studies managed in-house and through CRO partners.
Demonstrated sound judgment and problem-solving ability related to regulatory requirements, external partners, timelines, and complex clinical programs.
Excellent planning, communication, negotiation, and organizational skills.
Strong knowledge of the drug development process, ICH guidelines, and GCP, with a deep understanding of clinical trial execution and the ability to apply this knowledge to complex global studies.
This is the pay for this position
Pay Transparency
$174,000—$204,000 USD
Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.
Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at [email protected] to obtain prior written authorization before referring any candidates to Summit.
Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Summit Therapeutics’ mission is to resolve serious, unmet medical needs for the betterment of overall human health.
Industry
Biotechnology Research
Company size
201-500 employees
Founded
2003
Headquarters
Miami, Florida
LinkedIn followers
59,582
Total funding
$1.8B
Summit Mission Statement:
To build a viable, long-lasting health care organization that assumes full responsibility for designing, developing, trial execution and enrollment, regulatory submission and approval, as well as successful commercialization of patient, physician, caregiver, and societal-friendly medicinal therapy intended to: improve quality of life, increase potential duration of life, and resolve serious medical healthcare needs. To identify and control promising product candidates based on exceptional scientific development and administrational expertise, develop our products in a rapid, cost-efficient manner, and to engage commercialization and/or development partners when appropriate.
We accomplish this by building a team of world class professional scientists and business administrators that apply their experience and knowledge to this mission. Team Summit exists to pose, strategize, and execute a path forward in medicinal therapeutic health care that places Summit in a well-deserved, top market share, leadership position. Team Summit assumes full responsibility for stimulating continuous expansion of knowledge, ability, capability, and well-being for all involved stakeholders and highly-valued shareholders.
Summit was founded in 2003 and our shares are listed on the Nasdaq Global Market (symbol ‘SMMT’). We are headquartered in Miami, Florida, and we have additional offices in Palo Alto, California, Princeton, New Jersey, Oxford, UK, and Dublin, Ireland.
Offices: 601 Brickell Key Dr, Suite 1000, Miami, Florida 33131, US · 1000 Page Mill Rd, Palo Alto, California 94304, US · 136a Eastern Avenue, Milton Park, Abingdon, Oxfordshire OX14 4SB, GB · 502 Carnegie Center, Suite 102, Princeton, New Jersey 08540, US · 5 Harcourt Road, Dublin, D02 FW64, IE
OncologyClinical Trialsand Health CareHealth CareMedical DeviceBiotechnologyTherapeutics
Based on 416 listings with disclosed salaries, most healthcare jobs in Princeton, NJ pay between $81k–$240k per year. Individual offers vary with seniority, company size, and specialization.
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