Director of Safety Data Operations and Governance

Role Summary

The Director of Safety Data Operations and Governance is responsible for identifying, gaining access to, organizing, and establishing governance structures for data sources that provide patient safety insights, including clinical trial, preclinical, and post-market data. The role ensures data is managed in compliance with Johnson & Johnson standards and regulatory requirements, enabling proactive risk assessment and signal detection. It develops the operational structure and framework to leverage preclinical, clinical, quality, and technical data available in the Electrophysiology organization. This Flex/Hybrid role requires 3 days onsite per week in Irvine, CA, with the possibility of remote work within the US; travel to Irvine, CA may be required monthly.

Responsibilities

• Data Identification & Access: Identify internal and external data sources relevant to patient safety, including but not limited to clinical trials, preclinical studies, and post-market surveillance.
• Secure access to these data sets in collaboration with cross-functional teams (R&D, Clinical, Regulatory, Quality, IT, Legal).
• Data Organization & Governance: Develop and implement a governance framework for data use within the EP Organization.
• Ensure compliance with data privacy, security, and regulatory standards.
• Maintain documentation of data sources, ownership, and usage guidelines.
• Integration & Insights: Partner with Medical Safety Officer, Medical Affairs, Clinical Operations, R&D, Quality, Epidemiology, and Data Science teams to integrate data for safety signal detection and risk assessment.
• Support development of dashboards and analytics tools to monitor patient safety trends.
• Cross-Functional Collaboration: Act as a liaison between Medical Safety, Medical Affairs, Clinical Operations, Regulatory Affairs, R&D, Quality, Legal and IT to ensure seamless data flow.
• Provide training and guidance on data governance best practices.
• Additional Tasks (as Requested)
  • Establish processes for continuous improvement of data governance practices.
  • Develop KPIs and metrics to measure data quality and governance effectiveness.
  • Lead audits and compliance checks related to data governance.
  • Support strategic initiatives for global harmonization of safety data standards.

Qualifications

• Required: Bachelor's, Master’s or PhD degree in Life Sciences or related field.
• Required: Experience in data governance, clinical data management, or pharmacovigilance.
• Required: Strong understanding of regulatory requirements for clinical and post-market data.
• Required: Expertise in integrating diverse data sources and leveraging analytics for safety and regulatory decision-making.
• Required: Strong track record of cross-functional leadership and collaboration.
• Required: Excellent communication and stakeholder management skills.
• Preferred: Familiarity with Johnson & Johnson Quality Management Systems and Medical Safety processes.
• Preferred: Doctor of Medicine (MD), Doctor of Osteopathy (DO), or equivalent degree, such as MBChB.
• Preferred: Knowledge of data analytics tools and platforms. (Data Science)
• Preferred: Experience with regulatory compliance, data governance, and the development of frameworks and guidance to ensure data integrity and patient safety.

Skills

• Advanced Analytics
• Budget Management
• Compliance Management
• Critical Thinking
• Data Analysis
• Data Privacy Standards
• Data Quality
• Data Reporting
• Data Savvy
• Data Science
• Data Visualization
• Developing Others
• Digital Fluency
• Inclusive Leadership
• Leadership
• Program Management
• Strategic Thinking
• Succession Planning

Additional Requirements

• Remote work within the United States may be possible, but travel to Irvine, CA is required monthly.