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

Role: Lead risk management strategy and practices across clinical development portfolios in immunology, neuroscience, and aesthetics. Objectives include enhancing proactive risk identification, assessment, mitigation, and monitoring, embedding data-driven approaches into protocol design and study operations. Responsibilities involve leading a team of Risk Management Leads, developing risk insights and dashboards, overseeing RAMP processes, addressing resource gaps, and collaborating with cross-functional stakeholders to improve risk management practices. Qualifications: Bachelor's in life sciences or related field; 15+ years in clinical research, operations, or risk management, with 5+ years in leadership. Expertise in risk-based quality management (RBQM), applying ICH-GCP E6(R2), and experience with risk assessments, RAMP, and risk-based study modifications across multiple programs and therapeutic areas. Knowledge of regulatory guidelines (FDA, EMA, ICH), GCP, and global compliance required; professional risk management certifications preferred. Experience with data analytics tools (Power BI, Tableau), protocol design input, and leading matrixed teams is essential. High-Value: Focus on clinical risk management in immunology, neuroscience, and aesthetics; experience with risk-based quality systems; development stage likely clinical trials; hybrid work setup in Lake County, IL, or Irvine, CA, with on-site presence three days a week.