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

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.
• 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

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.

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