Director, Clinical Data Analytics & Safety Insights

Edwards Lifesciences Gruppe; Irvine (CA); On-site; USD 139,000 - 196,000; Full time

Job summary

Edwards Lifesciences invites a seasoned Clinical Safety Analytics leader to own end-to-end design, validation, and maintenance of safety dashboards for internal governance bodies. You will drive data reconciliation across clinical safety databases and ensure timely regulatory reporting.

You will mentor a growing team, partner with Biostatistics, Clinical Data Management, and Engineering, and translate safety requirements into scalable technical specifications for cloud-based dashboards.

Qualifications

• Bachelor's degree in a related field or equivalent experience.
• Demonstrated track record in people management and leadership.
• Experience in clinical safety/pharmacovigilance and regulatory aspects of medical devices is preferred.

Responsibilities

• Own end-to-end design, validation, and maintenance of clinical safety dashboards and reports for governance bodies.
• Lead safety data reconciliation across clinical databases, safety databases, and central lab/vendor sources.
• Ensure regulatory-compliant expedited/periodic safety reporting in partnership with PV/Regulatory.
• Manage a team responsible for safety data QC, dashboard build/maintenance, and ad hoc analytics.
• Partner with Biostatistics, Clinical Data Management, and Medical Safety on signal detection and dashboard logic.
• Collaborate with cloud/data engineering to translate needs into technical specs and data models.
• Develop and deliver presentations on clinical operations and study developments to stakeholders.
• Identify issues, drive root-cause resolution, and implement process improvements.

Skills

People management

Leadership

Project management

Data analysis

Python (pandas/NumPy)

BI tools

Communication

Education

Bachelor's Degree

Job description

Edwards Lifesciences invites a seasoned Clinical Safety Analytics leader to own end-to-end design, validation, and maintenance of safety dashboards for internal governance bodies. You will drive data reconciliation across clinical safety databases and ensure timely regulatory reporting.

You will mentor a growing team, partner with Biostatistics, Clinical Data Management, and Engineering, and translate safety requirements into scalable technical specifications for cloud-based dashboards.