Director of Safety Data Operations and Governance

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

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Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.

Are you passionate about improving and expanding the possibilities of Cardiovascular Ready to join a team thats reimagining how we heal Our Cardiovascular team develops leading solutions for heart recovery electrophysiology and stroke. You will join a proud heritage of continually elevating standards of care for stroke heart failure and atrial fibrillation (AFib) patients.

Your unique talents will help patients on their journey to wellness. Learn more at are searching for the best talent for a Director of Safety Data Operations and Governance to support our Electrophysiology business. This role will work a Flex/Hybrid schedule with 3 days per week onsite in our Irvine CA office. There is a possibly for the role to be remote within the US but travel to Irvine CA would be required monthly.

Purpose:

The Director of Safety Data Operations and Governance is responsible for identifying gaining access to organizing and establishing governance structures for all data sources that can provide patient safety insights. This includes but is not limited to clinical trial data preclinical data and post-market surveillance data. The role ensures that data is managed in compliance with Johnson & Johnson standards and regulatory requirements enabling proactive risk assessment and patient safety signal detection.

This individual is responsible for the development of the operational structure and framework of management to leverage preclinical clinical quality and technical data available in the Electrophysiology organization.

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.

Requirements:

• Bachelors Masters or PhD degree in Life Sciences or related field.
• Experience in data governance clinical data management or pharmacovigilance.
• Strong understanding of regulatory requirements for clinical and post-market data.
• Expertise in integrating diverse data sources and leveraging analytics for safety and regulatory decision-making.
• Strong track record of cross-functional leadership and collaboration
• Excellent communication and stakeholder management skills.

Preferred Skills:

• Familiarity with Johnson & Johnson Quality Management Systems and Medical Safety processes.
• Doctor of Medicine (MD) Doctor of Osteopathy (DO) or equivalent degree such as MBChB
• Knowledge of data analytics tools and platforms. (Data Science)
• Experience with regulatory compliance data governance and the development of frameworks and guidance to ensure data integrity and patient safety.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via Internal employees contact AskGS to be directed to your accommodation resource.

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Director