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.

Key Responsibilities

• 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.