Risk Management Lead

AbbVie Inc.; Marlow; Hybrid; GBP 90,000 - 130,000; Full time

Job summary

AbbVie is seeking a Risk Management Lead to drive end-to-end RBQM strategy across global clinical trials. You will work with study teams and Central Monitoring to foster proactive risk mitigation and regulatory compliance.

The role requires strengthening risk controls, defining KRIs, and guiding cross-functional partners in risk mindset and process maturity, in a hybrid environment with onsite presence in Marlow.

Qualifications

• Bachelor’s degree in life sciences, risk-based, or related discipline; advanced degree preferred.
• Extensive experience in clinical operations with risk management, RBQM, or quality management.
• Strong knowledge of risk management methodologies including identification, assessment, mitigation, and documentation.
• Ability to influence cross-functional teams and drive change in a global, multi-jurisdictional environment.
• Solid understanding of ICH/GCP, regulatory standards, and clinical trial processes.

Responsibilities

• Lead embedding and adoption of the RBQM model within clinical study teams.
• Partner with cross-functional leads to implement risk management strategies across programs.
• Facilitate RAMP meetings and maintain RBQM documentation through study lifecycle.
• Define KRIs and risk controls; align risk discussions with study plans and monitoring.
• Coach teams in risk mindset and process maturity; drive continuous improvement.
• Analyze quality metrics and risk signals to enable early interventions.
• Monitor mitigation execution, track trends, and document risks and actions.
• Support inspection readiness, audits, and regulatory compliance with QA teams.
• Lead RBQM process optimization and knowledge sharing across studies.

Skills

Risk management

RBQM

Quality management

Cross-functional collaboration

Data analysis/visualization

Regulatory understanding

Stakeholder influence

Problem solving

Communication

Education

Bachelor’s degree in life sciences or related discipline

Advanced degree preferred

Job description

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Risk Management Lead (RML) serves as the subject matter expert for risk management and central monitoring in AbbVie’s Risk-Based Quality Management (RBQM) model. The RML leads the strategic planning, implementation, and continuous improvement of risk management practices across global clinical trials, partnering closely with study teams and Central Monitoring colleagues to cultivate a proactive and sustainable risk-mitigation culture in support of high-quality study execution and regulatory compliance.

• Lead embedding and adoption of the end-to-end RBQM model within and across clinical study teams.
• Partner with cross-functional leads to develop and implement risk management strategies across therapeutic areas/programs.
• Facilitate Risk Assessment and Mitigation Planning (RAMP) meetings; prepare, review, and update RAMP documentation throughout the study lifecycle.
• Guide cross-functional teams in identifying critical data/processes, defining relevant Key Risk Indicators (KRIs), and establishing effective risk controls and response plans.
• Ensure alignment of risk discussions with study plans and global monitoring strategies.
• Coach and influence teams in risk mindset, methodology, and process maturity while fostering organizational capabilities.
• Analyze quality metrics/data and risk signals across study, regional, and site levels to drive continuous improvement and early intervention.
• Monitor risk mitigation execution, track issue trends, and ensure proper documentation, escalation, and communication of risks/issues.
• Support inspection readiness, audit response, and regulatory compliance, in collaboration with Clinical Process Compliance and Quality Assurance.
• Lead and contribute to RBQM process optimization, knowledge sharing, and best practice dissemination across studies and therapeutic areas.

Qualifications

• Bachelor’s degree in life sciences, risk-based, or related discipline; advanced degree preferred.
• Extensive comprehensive experience in clinical operations, with proven expertise in risk management, RBQM, or quality management.
• Excellent working knowledge of risk management methodologies (including risk identification, assessment, mitigation, and documentation).
• Demonstrated ability to influence cross-functional teams, senior management, and drive change management initiatives.
• Deep understanding of ICH/GCP, regulatory standards, and clinical trial processes.
• Strong analytical, critical thinking, and problem-solving skills; proficiency with data analysis/visualization tools.
• Exceptional communication, documentation, and interpersonal skills.
• Proven ability to lead in a dynamic global environment with complex, multi-jurisdictional studies.
• Mandatory hybrid model: 3 days onsite (Marlow)

Key Stakeholders: Clinical Site Management (CSM), Clinical Study Leadership (CSL), Strategic Clinical Operations, Therapeutic Area Medical Directors, Data Science, Compliance, Clinical Process Compliance, Quality Assurance, Vendor Management, and other cross-functional partners.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html