Director, Clinical Risk Management

The Director, Clinical Risk Management Post Approval Delivery Unit oversees the overall risk management of a Disease Area Stronghold (DAS) or development phase. Works with CRM Representatives to ensure the coordination of, identification, assessment, and mitigation of quality risks that could have an impact on trial data integrity, patient rights, safety, or well-being. You also provide oversight to the execution of data-driven, risk-based trial and program oversight activities that deliver quality in the execution of clinical trial programs, compliance with regulatory requirements and internal procedures, and that there is a continued state of inspection readiness.

You will be responsible for:

• People Leader Responsibilities
  • Establishes goals and objectives for CRM Representatives.
  • Performs mid-year and end-of-year review for CRM Representatives.
  • Assists in outlining and evaluating career development goals with CRM Representatives.
  • Works with team members to establish workstreams to update processes for efficiency and maintaining inspection readiness.
  • Coordinates upskilling knowledge workshop series for CRM Representative team development.
• Risk Management
  • Ensures CRM representatives are invited to actively participate in pre-study activities, contributing to the identification and assessment of key risks in the clinical protocol/set-up and advising clinical/cross functional trial team members on effective mitigation strategies.
  • Ensures a consistent quality risk assessment process across the program.
  • Provides and leads strategic guidance to CRM representatives on quality risk assessments, risk entries, and mitigation strategies.
  • Independently drives quality risk monitoring reviews and coaches others on risk monitoring and mitigation reviews.
  • Ensures a strategic communication framework with business partners and quality management governance to keep them informed on key quality risks and mitigations.
  • Communicates and facilitates risk updates to R&D Business Partners as part of the regular review cycle through Quality Working Groups and Governance Fora, as applicable.
  • Works with risk owners to develop effective risk mitigation plans to control risks in the trial level CQP.
  • Highlights new potential systemic risks to RDQ / CRM management.
• Issue Consultation, Issue Escalation, and Compliance Assessment
  • Develops and ensures a consistent interpretation of issues that require quality investigations.
  • Provides guidance for significant quality issues (SQI) per corporate standards and escalates SQI to senior R&D management.
  • Provides initial serious breach evaluation of quality issue that may require reporting to Health Authorities.
  • In collaboration with partners in RDQ, provides advice on the development and implementation of Corrective and Preventative Action (CAPA) Plans and Effectiveness Checks.
• Inspection Readiness and Support
  • Independently leads key inspection processes and inspection tools to maintain an ongoing inspection readiness with trial teams to develop inspection narratives, identify and prepare sites of interest for inspection.
  • Provides front and back room support for Sponsor-Monitor inspections at J&J Sites including post inspection support.
  • Provides remote support for investigational site inspections including post inspection support.
  • Provides mentorship and/or coaching for others on inspection support and readiness.

Requirements/Qualifications

• A minimum of a Bachelor’s degree (scientific, medical, or related discipline) is required.
• A minimum of 10 years working in the healthcare industry (pharmaceutical industry, contract research organization and/or healthcare/hospital system) is required.
• Proven strong GCP Quality and/or clinical trials experience is required.
• Excellent interpersonal, oral, and written communication skills to effectively collaborate in a cross-functional team environment is required.
• Flexibility to respond to changing business needs is required.
• Experience with fundamentals of clinical trial risk management is preferred.
• Experience working to ICH guidelines is preferred.
• Health Authority Inspection experience (FDA, EMA, and other inspectorates) is preferred.
• Experience in managing escalations and CAPA support/advisement is preferred.

Johnson & Johnson is an equal opportunity employer. We provide an inclusive work environment where each person is considered as an individual.