Director, Early Development Clinical Risk Management

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. Learn more at https://www.jnj.com Job Function: Quality Job Sub Function: Clinical Quality Job Category: People Leader All Job Posting Locations: Beerse, Antwerp, Belgium Job Description: Johnson & Johnson is currently seeking a Director, Early Development Clinical Risk Management to join our R&D Quality Clinical Risk Management team located in Raritan, NJ, Spring House, PA, Horsham, PA, Titusville, NJ, or Beerse, BE. 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 of America - Requisition Number: R-005145 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. The Director, Early Development Clinical Risk Management, reports to the Sr.
Director, Oncology/Early Development, and is primarily responsible to oversee the overall risk management of the Early Development (ED) phase across therapeutic areas.
They work with the CRM Representatives to ensure the coordination of the identification, assessment, and mitigation of quality risks that could have an impact on trial data integrity, patient rights, safety, or well–being. Key responsibilities: * Oversee 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; * Manage a team of CRM representatives that will provide consistent quality oversight to clinical trials in the ED portfolio; * Provide and lead strategic guidance to CRM representatives on quality risk assessments, risk entries, and mitigation strategies.
Approve CQP (Clinical Quality Plans) risk monitoring information in the quality risk repository to facilitate regular progress reviews; * Independently drive quality risk monitoring reviews and coach others on risk monitoring and mitigation reviews; * Ensure a strategic communication framework with business partners and quality management governance to keep them informed on key quality risks and mitigations; * Communicate and facilitate risk updates to R&D Business Partners as part of the regular review cycle through Quality Working Groups and Governance Fora, as applicable (trial and/or compound, as assigned); * Develop and ensure a consistent interpretation of issues that require quality investigations; * Provide guidance for significant quality issues (SQI) per corporate standards and escalates SQI to senior R&D management; * In collaboration with partners in RDQ, provide advice on the development and implementation of Corrective and Preventative Action (CAPA) Plans and Effectiveness Checks (Self - Identified, Inspection, Audit); * Independently lead 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; * Provide remote support for investigational site inspections including post inspection support; * Provide 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; * Participate in CRM, cross-RDQ JJIM, cross-functional, or cross-sector working groups to develop or refine processes, tools, and systems that deliver innovative quality solutions (as a team member or workstream/project lead); * Work with limited supervision, independently making quality decisions for compounds and studies; The Director, Early Development Clinical Risk Management is highly visible to the RDQ Leadership team and ensures robust quality trial oversight of the ED portfolio through quality risk management and execution of quality support services. Qualifications: * A minimum of a Bachelor's degree (scientific, medical, or related discipline) is required. * Advanced degree in an applicable field of study or certification is preferred. * A minimum of 10 years working in the healthcare industry (pharmaceutical industry, contract research organization and/or healthcare/hospital system) is required. * Demonstrates experience or recognizes potential for people leadership in formal or informal setting as needed 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. * Oncology Drug Development experience 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. * Requires up to 10% travel, primarily domestic with some international travel.

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