Drive portfolio-level risk identification and mitigation strategies in partnership with therapeutic area teams, enhancing proactive management of study and program risks.
Support and collaborate with the Integrated Evidence Strategy Team (IEST) to embed critical-to-quality elements into protocol design, ensuring data collection is focused on decision-making needs.
Lead, develop, and mentor a team of Risk Management Leads, fostering expertise, collaboration, and innovation in risk-based quality management.
Oversee the development and execution of therapeutic area risk insights, dashboards, and mitigation plans, promoting a deep understanding of risk drivers and solutions.
Ensure robust RAMP (Risk Assessment and Mitigation Plan) processes, tracking accountability and ensuring timely, data-driven risk action planning.
Address resource gaps by overseeing RAMP entry work and supporting the implementation of risk-based modifications to the scope of studies assigned to Study Risk Leads (SRLs), advocating for full resource needs where required.
Collaborate with cross-functional stakeholders (including Clinical Site Management, Clinical Study Leadership, Data Science, and Compliance) to ensure alignment and consistency in risk management practices.
Contribute to the development, standardization, and continuous improvement of risk management best practices, metrics, and training across the organization.
Impact and Influence:
Deepens portfolio and program risk management capabilities and accountability.
Leads a critical-to-quality, focused approach to data collection, supporting pipeline decision-making on sound data.
Supports a culture of continuous improvement, transparency, and evidence-driven risk mitigation.
**This is a hybrid position working on-site T-TH. Candidates must be local to Lake County, IL or Irvine, CA and work on-site 3 days a week.
Minimum of a bachelor's degree in life sciences, healthcare, pharmacy, nursing, or a related field; an advanced degree (Master's, PharmD, PhD, MD) is strongly preferred.
At least 15 years of experience in clinical research, clinical operations, or study/data risk management, with a minimum of 5 years in a leadership or people management capacity.
Demonstrated expertise in risk-based quality management (RBQM), including experience applying ICH-GCP E6(R2) risk-based methodology and risk management best practices in clinical development.
Direct hands-on experience with portfolio-level risk assessments, Risk Assessment and Mitigation Planning (RAMP), and implementing risk-based modifications across multiple clinical programs/therapeutic areas.
Strong knowledge of relevant regulatory guidelines (FDA, EMA, ICH), Good Clinical Practice (GCP), and global health authority requirements for clinical trials.
Experience with critical-to-quality (CtQ) elements, protocol design input, and collaboration with evidence strategy teams preferred.
Demonstrated success developing, mentoring, and leading teams, preferably in a matrixed global environment.
Advanced skills in data analytics, dashboarding, and the use of data visualization tools (e.g., Excel, Power BI, Tableau) for risk oversight and decision-making support.
Excellent interpersonal skills; able to communicate complex concepts clearly, persuade stakeholders, and foster cross-functional collaboration.
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
Benefits
Health insurance
Additional Information
The TA Director of Risk Management Leads is responsible for overseeing and advancing risk management strategy, practices, and performance across clinical development portfolios within Immunology, Neuroscience, Aesthetics /Eye Care /Specialty therapeutic areas . This leader drives risk identification, assessment, mitigation, and monitoring, ensuring a critical-to-quality, data-driven approach is embedded in protocol design and study operations. By developing and leading a high-performing team of Risk Management Leads, the TA Director ensures effective oversight, RAMP accountability, and continuous improvement in risk management practices, with a specific focus on addressing resource gaps related to RAMP entry work and the implementation of risk-based study modifications.
Abbvie · North Chicago, IL