Director of Safety Data Operations and Governance

Johnson & Johnson•Irvine, CA

3d•Hybrid

About The Position

Fueled by innovation at the intersection of biology and technology, we’re 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 that’s 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 https://www.jnj.com/medtech We 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.

Requirements

Bachelor’s, Master’s 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.

Nice To Haves

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.

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.

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
The anticipated base pay range for this position is : $164,000.00 - $282,900.00