Assoc Director, Clinical Risk Management

Johnson & Johnson seeks an Assoc Director for Clinical Risk Management in Allschwil, CH. The role focuses on overseeing quality risks in clinical trials to ensure patient safety and regulatory compliance.

This position partners with trial and program teams to coordinate the identification, assessment, and mitigation of quality risks. The goal is to safeguard trial data integrity, patient safety, and rights while executing data-driven oversight activities that maintain inspection readiness and regulatory compliance.

Responsibilities

• Independently participates in study activities to identify key risks in clinical protocols and advises teams on mitigation strategies for complex trials.
• Leads regular reviews with Risk Owners to evaluate mitigation progress and identify new risks or additional needs.
• Maintains Clinical Quality Plans in the quality repository to facilitate progress reviews of quality support services.
• Drives quality risk monitoring reviews and coaches other team members on risk monitoring and mitigation.
• Communicates risk updates to R&D colleagues through Quality Working Groups and Governance Fora.
• Highlights potential systemic risks to RDQ CRM management.
• Develops consistent interpretations for issues requiring quality investigations.
• Provides guidance for significant quality issues per corporate standards and escalates them to senior R&D management.
• Advises on the development and implementation of Corrective and Preventative Action plans and effectiveness checks.
• Drives inspection readiness activities, including developing narratives, preparing sites, and coordinating mock inspections.
• Supports Investigator, Sponsor-Monitor, and third-party inspections, including post-inspection support.
• Provides independent advice on research quality and compliance questions in collaboration with Quality Professionals.

Requirements

• Bachelor’s degree in a scientific, medical, or related discipline.
• Minimum of 8 years of experience in the healthcare industry, including pharmaceuticals, CROs, or hospital systems.
• Proven strong experience in GCP Quality and/or clinical trials.
• Excellent interpersonal, oral, and written communication skills for cross-functional collaboration.
• Flexibility to respond to changing business needs.
• Ability to operate in culturally diverse environments with an understanding of regional and global business structures.
• Proficiency in Microsoft Office Applications.
• Experience with the fundamentals of clinical trial risk management.
• Experience working to ICH guidelines.
• Experience with Health Authority Inspections (FDA, EMA, and other inspectorates).
• Proficiency in speaking and writing English.

Nice to have

• Knowledge of Good Manufacturing Practice, Good Laboratory Practice, and/or Good Pharmacovigilance Practice.
• Strong Project Planning/Management skills.
• Experience in managing escalations and providing CAPA support/advisement.
• Experience with data analytics and/or data visualization tools (e.g., Tableau, Spotfire) to analyze data and drive decision-making.
• Experience with Data Science and Digital Health, including Real World Evidence/Real World Disease.

What the company offers

• An inclusive work environment where each person is considered as an individual.
• Commitment to providing an interview process that is inclusive of applicants’ needs.

About the company

Johnson & Johnson believes health is everything and aims to build a world where complex diseases are prevented, treated, and cured. Guided by its Credo, the company is responsible to its employees worldwide, respecting their diversity and dignity while recognizing their merit.

• The company believes health is everything and aims to build a world where complex diseases are prevented, treated, and cured.
• Guided by its Credo, the company is responsible to its employees who work with it throughout the world.
• The company respects the diversity and dignity of its employees and recognizes their merit.