Director of ICSR Knowledge & Process Optimization at Regeneron driving compliance and efficiency in safety report processing. Ensuring high - quality procedures and collaborating with cross - functional teams.
About the role
- Associate Director responsible for leading GMA study management for non-interventional studies across disease areas. Collaboration with cross-functional teams and strategic planning for operational excellence.
Responsibilities
- Lead planning, execution, and reporting of all GMA studies within assigned Disease Area
- Ensure timely, budget-compliant, and high-quality delivery of non-interventional and collaborative studies
- Partner with Study Management Director for resource planning and strategic prioritization
- Manage internal and external teams to ensure capacity and capability alignment
- Identify risks early and implement effective mitigation strategies with leadership updates
- Represent GMA Study Management in PMAT and support TAMAT as needed
- Oversee CRO selection, contracting, and performance in collaboration with vendor management
- Coordinate study-related communications and prepare content for review meetings
- Foster strategic partnerships with institutions, KOLs, and external collaborators
- Promote compliance, process simplification, and operational excellence across study operations
Requirements
- Master’s degree in science; PhD or PharmD preferred
- Minimum 8 years of experience in clinical trial operations within pharma or CRO settings
- Proven ability to lead international, cross-functional teams in a matrix environment
- Strong knowledge of clinical development, GCP, and global medical affairs processes
- Demonstrated expertise in project management and stakeholder collaboration
- Excellent communication, problem-solving, and conflict resolution skills.
Benefits
- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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