Associate Director, Cross Therapeutic Area Clinical Risk Management (MedTech)

Location: Hybrid office-based role available in the United States, Belgium, Switzerland, the United Kingdom, or Spain; up to 10% travel, primarily domestic with some international travel.

Salary: $122,000–$212,750 annually.

Company

Johnson & Johnson MedTech develops healthcare and medical solutions, while Johnson & Johnson's Innovative Medicine organization develops treatments and cures across the healthcare spectrum.

What you will do

• Coordinate the identification, assessment, monitoring, and mitigation of quality risks affecting clinical trial data integrity, patient safety, well-being, and rights.
• Advise trial and program teams on risk management for complex protocols, compounds, and clinical programs.
• Lead regular risk reviews, maintain Clinical Quality Plans, and communicate risk updates through Quality Working Groups and governance forums.
• Guide quality investigations, significant quality issue escalations, CAPA plans, and effectiveness checks.
• Drive inspection readiness, including inspection narratives, site preparation, document availability, mock inspections, and post-inspection support.
• Provide advice on clinical research quality, international regulations, and internal procedures while coaching peers and new employees.

Requirements

• Bachelor’s degree in a scientific, medical, or related discipline.
• At least 8 years of experience in healthcare, pharmaceuticals, contract research, or a healthcare or hospital system.
• Strong GCP quality and clinical trials experience, including clinical trial risk management and work with ICH guidelines.
• Health authority inspection experience with FDA, EMA, or other inspectorates.
• Excellent communication and collaboration skills in culturally diverse, cross-functional environments.
• Proficiency in spoken and written English is required.

Nice to have

• Knowledge of GMP, GLP, or GPvP.
• Project planning and management, escalation management, and CAPA advisory experience.
• Experience with Tableau, Spotfire, or related data analytics and visualization tools.
• Experience with data science, digital health, real-world evidence, or real-world disease data.

Culture & Benefits

• Inclusive work environment focused on diversity, dignity, and individual merit.
• Retirement pension and 401(k) savings plans, subject to applicable plan terms.
• Eligibility for a long-term incentive program.
• Vacation, sick time, holidays, personal and family time, parental, caregiver, bereavement, volunteer, and military spouse leave benefits.