Risk Management Lead

AbbVie; United States; Hybrid; USD 140,000 - 210,000; Full time

Job summary

AbbVie seeks a Risk Management Lead to drive RBQM across global clinical trials, partnering with study teams to embed risk-management practices and continuous improvement. You will guide KRIs, risk controls, and documentation, ensuring training and change management across functions to uphold quality and compliance.

The role requires 10+ years in clinical operations with risk management expertise, ICH/GCP knowledge, and strong analytical and communication skills.

Qualifications

• Bachelor’s degree in life sciences, risk-based, or related discipline; advanced degree preferred.
• Minimum of 10 years’ 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.

Responsibilities

• 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 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.

Skills

RBQM

Risk management

Clinical operations

Cross-functional

Data analysis

Communication

Education

Bachelor's degree in life sciences

Advanced degree preferred

Job description

About AbbVie

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,XandYouTube.

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.

Key Responsibilities:

• 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.

• Bachelor’s degree in life sciences, risk-based, or related discipline; advanced degree preferred.


• Minimum of 10 years’ 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.

This is a hybrid based role working onsite T-TH. Candidates must be local to Lake County, IL; Irvine, CA or Florham Park, NJ and work onsite 3 days per week.

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.


• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.


• This job is eligible toparticipatein our long-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable law.

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