TA Director, Risk Management Lead - Multiple Therapeutic Areas (Hybrid)
AbbVie
August 19, 2026
Remote friendly (Florham Park, NJ)
United States
$160,500 - $305,000 USD yearly
Clinical Research and Development
TA Director of Risk Management Leads (Hybrid)
Key Responsibilities:
- Oversee and advance portfolio-level risk management strategy, practices, and performance across Immunology, Neuroscience, and Aesthetics/Eye Care/Specialty therapeutic areas.
- Drive risk identification, assessment, mitigation, and monitoring; embed critical-to-quality, data-driven approaches into protocol design and study operations.
- Partner with therapeutic area teams and the Integrated Evidence Strategy Team (IEST) to incorporate critical-to-quality elements into protocols.
- Lead, develop, and mentor a team of Risk Management Leads.
- Oversee therapeutic area risk insights, dashboards, and mitigation plans.
- Ensure robust RAMP (Risk Assessment and Mitigation Plan) processes, accountability, and timely risk action planning.
- Address resource gaps by overseeing RAMP entry work and supporting risk-based study scope modifications.
- Collaborate cross-functionally (Clinical Site Management, Clinical Study Leadership, Data Science, Compliance) to align risk management.
- Standardize and continuously improve risk management best practices, metrics, and training.
Qualifications:
- BS in life sciences/healthcare/pharmacy/nursing or related field; Master’s/PharmD/PhD/MD preferred.
- 15+ years in clinical research/operations/study/data risk management, including 5+ years in leadership/people management.
- Demonstrated RBQM expertise using ICH-GCP E6(R2).
- Hands-on RAMP, portfolio risk assessments, and risk-based modifications across programs/therapeutic areas.
- Strong knowledge of FDA/EMA/ICH, GCP, and global clinical trial requirements.
- Risk management certifications highly desirable.
- Experience with CtQ elements and protocol design input preferred.
- Advanced analytics/dashboarding (Excel, Power BI, Tableau).
Benefits (if included): Paid time off; medical/dental/vision; 401(k); eligible for short-term incentive programs.
Hybrid: On-site T-TH; local to Lake County, IL or Irvine, CA; work on-site 3 days/week.
Key Responsibilities:
- Oversee and advance portfolio-level risk management strategy, practices, and performance across Immunology, Neuroscience, and Aesthetics/Eye Care/Specialty therapeutic areas.
- Drive risk identification, assessment, mitigation, and monitoring; embed critical-to-quality, data-driven approaches into protocol design and study operations.
- Partner with therapeutic area teams and the Integrated Evidence Strategy Team (IEST) to incorporate critical-to-quality elements into protocols.
- Lead, develop, and mentor a team of Risk Management Leads.
- Oversee therapeutic area risk insights, dashboards, and mitigation plans.
- Ensure robust RAMP (Risk Assessment and Mitigation Plan) processes, accountability, and timely risk action planning.
- Address resource gaps by overseeing RAMP entry work and supporting risk-based study scope modifications.
- Collaborate cross-functionally (Clinical Site Management, Clinical Study Leadership, Data Science, Compliance) to align risk management.
- Standardize and continuously improve risk management best practices, metrics, and training.
Qualifications:
- BS in life sciences/healthcare/pharmacy/nursing or related field; Master’s/PharmD/PhD/MD preferred.
- 15+ years in clinical research/operations/study/data risk management, including 5+ years in leadership/people management.
- Demonstrated RBQM expertise using ICH-GCP E6(R2).
- Hands-on RAMP, portfolio risk assessments, and risk-based modifications across programs/therapeutic areas.
- Strong knowledge of FDA/EMA/ICH, GCP, and global clinical trial requirements.
- Risk management certifications highly desirable.
- Experience with CtQ elements and protocol design input preferred.
- Advanced analytics/dashboarding (Excel, Power BI, Tableau).
Benefits (if included): Paid time off; medical/dental/vision; 401(k); eligible for short-term incentive programs.
Hybrid: On-site T-TH; local to Lake County, IL or Irvine, CA; work on-site 3 days/week.