Manager, Serious Breach Office

Scorpion Therapeutics; Horsham (PA); Hybrid; USD 120,000 - 165,000; Full time

Job summary

Johnson & Johnson's Clinical Risk Management team seeks a Manager of the Serious Breach Office to oversee compliance, process oversight, and continuous improvement of serious breach reporting for JJIM-sponsored clinical trials.

The role coordinates breach assessments, ensures timely reporting to health authorities, develops performance metrics, and leads process optimization with cross-functional teams across regions.

Qualifications

• Bachelor's degree in a scientific or medical field.
• 1–3 years of relevant experience in healthcare, pharma, medical devices, or biologics.
• Knowledge of clinical trial risk management, GCP, and serious breach reporting guidelines (ICH).

Responsibilities

• Facilitate breach assessments and ensure timely reporting to health authorities.
• Develop performance metrics and dashboards for serious breach management.
• Lead process optimization initiatives and drive continuous improvement.
• Perform data analysis and collaborate with stakeholders; represent SBO in strategic meetings.

Skills

Organizational skills

Project management

Stakeholder engagement

Communication

Data visualization

Education

Bachelor's degree in science

Tools

Tableau

Spotfire

Job description

Manager of the Serious Breach Office within Johnson & Johnson's Clinical Risk Management team, focusing on compliance, process oversight, and continuous improvement of serious breach reporting for JJIM-sponsored clinical trials.

Responsibilities include facilitating breach assessments, ensuring timely and accurate reporting to health authorities, developing performance metrics, and leading process optimization initiatives. The role also involves data analysis, dashboard creation, stakeholder collaboration, and representing the SBO in strategic meetings.

Requirements

• Bachelor's degree in a scientific or medical field
• 1-3 years of relevant experience in healthcare, pharma, medical devices, or biologics
• Knowledge of clinical trial risk management, GCP, and serious breach reporting guidelines (ICH)

Skills

• Strong organizational, project management, stakeholder engagement, and communication abilities
• Proficiency in data visualization tools (e.g., Tableau, Spotfire)

Preferred Qualifications

• Experience with clinical trial execution, document management, and compliance functions

High-value specifics

• Focus on clinical trial compliance in a regulated biopharma environment
• International and domestic travel (~10-15%)
• Collaboration across functions and regions

Locations

Flexible locations in North America or EMEA regions, with a preference for sites in New Jersey or Pennsylvania.