Risk Management Lead

AbbVie; Florham Park (NJ); Híbrido; USD 150.000 - 190.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical insurance

Dental insurance

401(k) plan

Paid time off

Descripción de la vacante

AbbVie in Lake County, IL; Florham Park, NJ, Irvine, CA, or other locations. The Risk Management Lead (RML) drives risk-based quality management across global clinical trials, partnering with study teams to embed RBQM and foster a proactive risk-mitigation culture for high-quality study execution.

The role requires a senior level of expertise in risk management, RBQM, and regulatory standards, with strong data analysis and cross-functional collaboration skills.

Formación

• Bachelor’s degree in life sciences or related discipline; advanced degree preferred.
• Minimum of 10 years’ experience in clinical operations with risk management, RBQM or quality management.
• Excellent knowledge of risk management methodologies (identification, assessment, mitigation, documentation).
• Ability to influence cross-functional teams and drive change in a global, multi-jurisdictional setting.
• Strong understanding of ICH/GCP, regulatory standards, and clinical trial processes.
• Proficient in data analysis/visualization tools and clear communication.

Responsabilidades

• Lead embedding and adoption of the RBQM model across clinical study teams.
• Partner with cross-functional leads to implement risk management strategies.
• Facilitate RAMP meetings and maintain RAMP documentation throughout the lifecycle.
• Identify critical data/processes, define KRIs, and establish risk controls and response plans.
• Ensure alignment of risk discussions with study plans and global monitoring strategies.
• Coach teams on risk mindset, methodology, and process maturity; promote best practices.
• Analyze quality metrics and risk signals to drive continuous improvement and early intervention.
• Monitor risk mitigation execution, track trends, and document risks and issues.
• Support inspection readiness, audits, and regulatory compliance with QA partners.
• Lead RBQM process optimization and knowledge sharing across studies.

Conocimientos

Risk management

RBQM

Regulatory knowledge

Data analysis

Stakeholder influence

Communication

Educación

Bachelor’s degree in life sciences or related discipline

Advanced degree preferred

Herramientas

Data analysis tools

Visualization tools

Descripción del empleo

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, X and YouTube.

Company 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, 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.

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.

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.

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.

Additional Information

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable 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