Sr Dir Clin Pathology Safety Biomarkers

Janssen is recruiting for a Global Director Clinical Pathology Safety Biomarkers , located in Spring House, PA or Beerse, Belgium.

The Global Director Clinical Pathology Safety Biomarkers (PSTS) is responsible for strategic and scientific oversight of internal clinical pathology laboratories globally in the US and Belgium supporting and advancing the discovery and development portfolio. The position requires demonstrated competence in all aspects of clinical pathology (Hematology, Clinical Chemistry, Urinalysis) with demonstrated expertise and experience with data driven hypothesis-testing approaches aimed at resolving pre-clinical or clinical issues of safety concern that could impede progression of drug candidates. Collaborative consultation of clinical pathology reports and data with the clinical pathology team, study toxicologists, target pathologists and program leads is essential to assure timely delivery, interpretation and correlation of study findings in support of early discovery, lead optimization, investigative studies in addition to out-sourced GLP registrational toxicology studies. The Global Director Clinical Pathology Safety Biomarkers  is expected to have an active leadership role in the Global Safety Biomarker Steering Committee and develop collaborative cross functional partnerships to advise on established safety biomarkers and advance the use and application of innovative platforms and technologies aimed at improving translational Safety Biomarkers

The Global Director Clinical Pathology Safety Biomarkers (PSTS) will report to the Global Head of Pathology PSTS as a member of the Global Pathology Leadership Team. Responsible for the development of employees within their line management. Work projects may be directed toward scientific, business, and people leader development and training of staff to meet current and future business needs. Will role model, champion and provide an environment that encourages the company’s commitment to equal employment opportunity and the value of a diverse work force.

Key Responsibilities:

• Responsible for the of interpretation or oversight of clinical pathology data and comprehensive clinical pathology reports.
• Provide oversight on the collection of clinical pathology data by laboratory staff and consultation to the interpretation of clinical pathology endpoints.
• Provide scientific expertise for experimental design and conduct of research studies.
• Participate in method development, and identification and evaluation of new instrumentation, as required for routine and established safety biomarkers and advance the use and application of innovative platforms and technologies aimed at improving translational Safety Biomarkers.
• Assist in expanding the array of clinical pathology assays to meet contemporary needs and expectations.
• Conduct on-site employee training in clinical pathology or related topics as needed for studies, specialty projects or continuing education.
• Assures seamless interface with strategic partnerships with clinical pathology data and reports with CROs and internal partners. Assures delivery on timelines and performance is consistent with quality and compliance to meet all business needs.
• Build competencies across Clinical Pathology to provide business continuity and sustainability for aspects of data quality and compliance standards for arenas relevant to pathology, GLP compliance, and specimen banking, as example.