TA Director, Risk Management Lead - Multiple Therapeutic Areas (Hybrid)

## Company Description **About AbbVie** AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [www.abbvie.com](http://www.abbvie.com/). Follow @abbvie on [LinkedIn,](https://www.linkedin.com/company/abbvie/) [Facebook](https://www.facebook.com/AbbVieGlobal/), [Instagram](https://www.instagram.com/abbvie/), [X](https://twitter.com/abbvie) and [YouTube.](https://www.youtube.com/user/AbbVie) ## Job Description 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.** ## Qualifications - 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 meth…