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.