TA Director, Risk Management Lead - Multiple Therapeutic Areas (Hybrid)
Core
Overseeing and advancing risk management strategy, practices, and performance across clinical development portfolios in Immunology, Neuroscience, and Aesthetics/Eye Care/Specialty areas.
Role type
Senior TA Director of Risk Management Leads
Builds
Risk-based study modifications and portfolio-level risk mitigation strategies
Domain
Clinical Research / Life Sciences
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk-based quality management (RBQM), ICH-GCP E6(R2) methodology, RAMP (Risk Assessment and Mitigation Plan) execution, portfolio-level risk assessment, regulatory guideline knowledge (FDA, EMA, ICH), GCP compliance, data analytics, dashboarding, team leadership, protocol design input
Preferred skills
Advanced degree (Master's, PharmD, PhD, MD), experience in matrixed global environments, critical-to-quality (CtQ) elements, evidence strategy collaboration
Technologies
Excel, Power BI, Tableau
Responsibilities
Drive portfolio-level risk identification and mitigation strategies; Lead, develop, and mentor a team of Risk Management Leads; Oversee development and execution of therapeutic area risk insights and mitigation plans; Ensure robust RAMP processes and tracking; Collaborate with cross-functional stakeholders to align risk management practices; Contribute to standardization and continuous improvement of risk management best practices
Seniority
Senior, hands-on IC with people management capacity