Associate Director, Clinical Risk Management

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.
Learn more at jnj.com. 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. Job Function

Quality Job Sub Function

Clinical Quality Job Category

Professional All Job Posting Locations

Beerse, Antwerp, Belgium, Madrid, Spain

Job Description

Johnson & Johnson is currently seeking an Associate Director, Cross Therapeutic Area Clinical Risk Management to join our R&D Quality CRM team located at a J&J office in Spring House, PA; Horsham, PA; Titusville, NJ; Raritan, NJ; Beerse, Belgium; Basel, Switzerland; High Wycombe, UK; Madrid, Spain. Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): United States
- Requisition Number: R-083139 Switzerland
- Requisition Number: R-085157 United Kingdom
- Requisition Number: R-085163 Belgium/Madrid
- Requisition Number: R-085167 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Job description
to follow: The Associate Director, Cross TA Clinical Risk Management, works with the trial teams and/or Program teams to coordinate the identification, assessment, and mitigation of quality risks that couldimpact ontrial data integrity, patient safety,well –being, or rights.
Throughout the duration of the trial/program, this Associate Director executes data-driven, risk-based trial oversight activities to deliver quality in the execution of clinical trials (and/or programs), compliance with regulatory requirements and internal procedures, and tomaintaina continued state of inspection readiness.

Key responsibilities

Actively and independently participatesin allstudy activities, contributing to the identification and assessment of key risks in the clinical protocol/set-up and advising clinical team members on effective mitigation strategies for complex clinical trials, compounds and programs. Leads regular review of risk areas in collaboration with Risk Owners, to evaluate progress of risk mitigations and risk reduction, and toidentifypotential new risks oradditionalmitigation needs (trial and/or compound, as assigned). Maintains CQP (Clinical Quality Plans) in quality repository tofacilitateregular progress reviewsof quality support services in addition to risks and mitigations Independently drives quality risk monitoring reviews andcoachesothers on risk monitoring and mitigation reviews Communicatesandfacilitatesrisk updates to R&D colleagues as part of the regular review cyclethrough Quality Working Groups and Governance Fora, as applicable(trial and/or compound, as assigned). Highlight new potential systemic risk toRDQCRMmanagement. 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. In collaboration with partners inRDQ, provides advice on the development and implementation of Corrective and Preventative Action (CAPA) Plans and Effectiveness Checks (Self -Identified, Inspection, Audit) Drivesongoing inspection readiness activities with trial teams to develop inspection narratives,identifyand prepare sites of interest for inspection (including, pre-inspectionvisitsupport), ensure availability of key documents/recordsand coordinatesmock inspectionincollaboration with RegulatoryCompliance teams. Provides supportfor Investigator, Sponsor-Monitor and third-partment inspections includingpost inspection support Providesindependent adviceon questions related to research quality and compliance from clinical teams