TA Director, Risk Management Lead - Multiple Therapeutic Areas (Hybrid)
AbbVie
August 18, 2026
Remote friendly (North Chicago, IL)
United States
$156,000 - $296,500 USD yearly
Clinical Research and Development
The TA Director of Risk Management Leads oversees and advances risk management strategy, practices, and performance across clinical development portfolios in Immunology, Neuroscience, and Aesthetics/Eye Care/Specialty.
Key Responsibilities:
- Drive portfolio-level risk identification and mitigation strategies with therapeutic area teams.
- Partner with the Integrated Evidence Strategy Team (IEST) to embed critical-to-quality elements into protocol design.
- Lead, develop, and mentor Risk Management Leads for risk-based quality management.
- Oversee therapeutic area risk insights, dashboards, and mitigation plans.
- Ensure robust RAMP (Risk Assessment and Mitigation Plan) processes and timely, data-driven risk actions.
- Address resource gaps by overseeing RAMP entry work and supporting risk-based study scope modifications.
- Collaborate with Clinical Site Management, Clinical Study Leadership, Data Science, and Compliance to align practices.
- Contribute to standardization and continuous improvement of risk management best practices, metrics, and training.
Qualifications:
- Bachelor’s degree in life sciences/healthcare/pharmacy/nursing or related; advanced degree strongly preferred.
- 15+ years clinical research/operations/study/data risk management; 5+ years in leadership/people management.
- RBQM expertise, including ICH-GCP E6(R2) risk-based methodology.
- Hands-on portfolio-level risk assessments, RAMP, and risk-based modifications across programs.
- Knowledge of FDA/EMA/ICH, GCP, and global clinical trial requirements.
- (Preferred) Risk management certifications (e.g., ASQ, CERA, CRM, PRM) and experience with CtQ elements/protocol input.
- Advanced analytics/dashboarding skills (Excel, Power BI, Tableau) and strong interpersonal communication.
Hybrid: On-site T-TH; local to Lake County, IL or Irvine, CA; work on-site 3 days/week.
Benefits: paid time off; medical/dental/vision insurance; 401(k); eligible for short-term incentive programs.
Key Responsibilities:
- Drive portfolio-level risk identification and mitigation strategies with therapeutic area teams.
- Partner with the Integrated Evidence Strategy Team (IEST) to embed critical-to-quality elements into protocol design.
- Lead, develop, and mentor Risk Management Leads for risk-based quality management.
- Oversee therapeutic area risk insights, dashboards, and mitigation plans.
- Ensure robust RAMP (Risk Assessment and Mitigation Plan) processes and timely, data-driven risk actions.
- Address resource gaps by overseeing RAMP entry work and supporting risk-based study scope modifications.
- Collaborate with Clinical Site Management, Clinical Study Leadership, Data Science, and Compliance to align practices.
- Contribute to standardization and continuous improvement of risk management best practices, metrics, and training.
Qualifications:
- Bachelor’s degree in life sciences/healthcare/pharmacy/nursing or related; advanced degree strongly preferred.
- 15+ years clinical research/operations/study/data risk management; 5+ years in leadership/people management.
- RBQM expertise, including ICH-GCP E6(R2) risk-based methodology.
- Hands-on portfolio-level risk assessments, RAMP, and risk-based modifications across programs.
- Knowledge of FDA/EMA/ICH, GCP, and global clinical trial requirements.
- (Preferred) Risk management certifications (e.g., ASQ, CERA, CRM, PRM) and experience with CtQ elements/protocol input.
- Advanced analytics/dashboarding skills (Excel, Power BI, Tableau) and strong interpersonal communication.
Hybrid: On-site T-TH; local to Lake County, IL or Irvine, CA; work on-site 3 days/week.
Benefits: paid time off; medical/dental/vision insurance; 401(k); eligible for short-term incentive programs.