Director,Clinical Risk Management Post Approval Delivery Unit

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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. If assigned, approves CQP (Clinical Quality Plans) risk monitoring information in quality risk repository to facilitate regular progress reviews. 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. Highlight new potential systemic risks to RDQ / CRM management.
• Issue Consultation, Issue Escalation, and Compliance Assessment: In consultation with the Head of Clinical Risk Management: 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 (Self - Identified, Inspection, Audit).
• 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 (including, pre-inspection visit support), ensure availability of key documents/records and coordinates mock inspection in collaboration with Regulatory Compliance teams. Provides front and back room support for Sponsor-Monitor inspections at J&J Sites including post inspection support. Provides inspection support per contractual agreement for third party inspections (vendors, co-development partners and contract research organizations). Provides remote support for investigational site inspections including post inspection support. Provides mentorship and/or coaching for others on inspection support and readiness.
• Consultancy: Provides independent advice on questions related to research quality and compliance from Business Partners in collaboration with other Quality Professionals and Subject Matter Experts to ensure consistent interpretation of international regulations and policy.
• Post-licensing and Acquisition (L&A) / Integration: With guidance from the RDQ L&A Team and Therapeutic Head or Delegate: Supports and leads the coordination of the quality integration of the acquiring asset or company/partner and delivers robust documentation within the program/trial integration plans (90-day plan) and execute assigned responsibilities per plan. Provides and leads general guidance to stakeholders. As required, provides, and leads input into Quality Agreements with (Co-)development Partners and executes responsibilities per agreement. Supports and facilitates asset divestment.

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.
• Demonstrated ability to operate in an environment of culturally diverse styles and business approaches by understanding regional and global business structures is required.
• Proficiency in Microsoft Office Applications is required.
• Experience with fundamentals of clinical trial risk management is preferred.
• Experience working to ICH guidelines is preferred.
• Knowledge of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and/or Good Pharmacovigilance Practice (GPvP) is preferred.
• Health Authority Inspection experience (FDA, EMA, and other inspectorates) is preferred.
• Strong Project Planning/Management skills is preferred.
• Experience in managing escalations and CAPA support/advisement is preferred.
• Experience and/or proficiency with data analytics and/or data visualization tools (i.e., Tableau, Spotfire, or related) to analyze/interpret collective data and provide insights to drive decision-making is preferred.
• Experience with Data Science and Digital Health (including Real World Evidence/Real World Disease) is preferred.
• Requires proficiency in speaking and writing English.
• Up to 10% of travel, primarily domestic with some international travel.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements.

Required Skills: Budget Management, Clinical Research and Regulations, Clinical Trials Operations, Compliance Management, Compliance Risk, Continuous Improvement, Developing Others, Fact-Based Decision Making, Inclusive Leadership, Leadership, Operations Management, Performance Measurement, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Risk Assessments, Standard Operating Procedure (SOP), Tactical Planning, Vendor Selection.