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 Med Tech, 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. Learn

more at  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.

Job Function:
Quality Job Sub Function:
Clinical Quality Job Category:

People Leader All Job Posting Locations:

High Wycombe, Buckinghamshire, United Kingdom

Job Description:

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 work streams 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 CQPHighlight 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…