Associate Director, Clinical Risk Management

Location: Hybrid role based at a Johnson & Johnson office in one of the following locations: High Wycombe, United Kingdom; Spring House, Horsham, Titusville, or Raritan, United States; Beerse, Belgium; Basel, Switzerland; or Madrid, Spain. Up to 10% travel is required, primarily domestic with some international travel.

Company

Johnson & Johnson develops healthcare, pharmaceutical, and MedTech solutions focused on preventing, treating, and curing complex diseases.

What you will do

• Coordinate the identification, assessment, monitoring, and mitigation of quality risks affecting clinical trial data integrity, patient safety, participant well-being, and rights.
• Advise clinical and program teams on risk management for complex trials, compounds, and programs.
• Lead risk monitoring reviews, maintain Clinical Quality Plans, evaluate mitigation progress, and identify emerging or systemic risks.
• Support quality investigations, Significant Quality Issues, CAPA plans, effectiveness checks, and escalation to senior R&D management.
• Drive inspection readiness, including inspection narratives, site preparation, document availability, mock inspections, and post-inspection support.
• Provide guidance on research quality and compliance while contributing to cross-functional quality working groups, process improvements, training, and coaching.

Requirements

• Bachelor’s degree in a scientific, medical, or related discipline.
• At least 8 years of experience in the healthcare, pharmaceutical, contract research, or healthcare system environment.
• Strong GCP quality and clinical trial experience, including clinical trial risk management and work with ICH guidelines.
• Experience with health authority inspections, including FDA, EMA, or other inspectorates.
• Strong communication, collaboration, project planning, and escalation-management skills.
• Proficiency in spoken and written English is required.

Nice to have

• Knowledge of GMP, GLP, or GPvP.
• Experience supporting CAPA activities and managing escalations.
• Experience with Tableau, Spotfire, or similar data analytics and visualization tools.
• Experience with data science, digital health, real-world evidence, or real-world disease data.

Culture & Benefits

• Inclusive work environment that respects diversity, dignity, and individual contributions.
• Opportunity to contribute to healthcare innovation and the development of medicines.
• Cross-functional and cross-sector collaboration across international R&D and quality teams.
• Hybrid work arrangement with travel of up to 10%.