Scientific Director, Biologics Toxicology: Janssen Research & Development, LLC is seeking a Scientific Director, Biologics Toxicology, for our Spring House, Pennsylvania location. The candidate will focus on the development of immuno-oncology biotherapeutics and gene therapies in various therapeutic areas. Lead Janssen BioTherapeutics subteams to develop species selection justification and first-in-human enabling nonclinical safety strategy. Independently identify and analyze high-impact, complex, and cross-department scientific and technical issues. Provide strategic and scientific input to Project Teams progressing biotherapeutics from discovery to market. Interface with worldwide regulatory agencies and prepare nonclinical sections of regulatory filings. Interface with CROs for protocol design, study execution, data interpretation, and report preparation. Contribute to decisions on new product and project acquisition. Educate others on toxicology requirements for drug development, and role of Biologics Toxicology in development process. Increase visibility for Johnson & Johnson through publications, participation in external organizations, and presentations at external meetings.
Qualified applicants will have a Ph.D. degree in pharmacology, toxicology, pharmaceutical science, immunology, cell biology, tumor biology, or molecular biology, and 8 years of biopharmaceutical nonclinical toxicology and drug development experience. The position requires experience with immunology/immunotoxicology in the immune-oncology therapeutic area; interacting with worldwide regulatory agencies; authoring text and preparing nonclinical sections of regulatory filings for biopharmaceuticals; leading multidisciplinary teams; working with FDA, EMA, and ICH guidance documents, including GLP regulations; and independently developing and implementing nonclinical strategies for establishing safety of potential new biopharmaceuticals for human use. Must have experience with toxicology study design, conduct, and interpretation; pharmacokinetic and pharmacodynamics relationships; and associated bioanalytical assays, translational sciences concepts, investigative pathology methods, and structure and function relationships of biopharmaceuticals. Experience serving as Study Director for nonclinical safety studies of biopharmaceuticals is required. Must have experience with inclusion of specialized immunologic parameters for assessment in standard toxicity studies; overseeing pre-study methods development at CRO; data interpretation; designing and defending scientific proposals; influencing multidisciplinary compound development teams dedicated to development of new therapeutic agents; and serving as representative for external scientific committees. Must have scientific publications in areas relevant to nonclinical safety aspects of biopharmaceutical development and in vivo immunotoxicology testing. Must have experience with identifying and resolving issues to ensure patient safety; conducting due diligence for potential in-licensing opportunities and/or acquisitions; developing partnered or in-licensed molecules; supporting nonclinical safety aspects of diverse biotherapeutic platforms including monoclonal antibodies, fusion proteins, antibody fragments, and peptides in multiple therapeutic areas; hands-on conduct of in vivo toxicology studies; and integration and interpretation of diverse, multidisciplinary data sets. Experience influencing across disciplines with senior leaders and external colleagues and partners to drive and align strategic and operational scientific activities between business units and functions is required. Up to 5% domestic and international travel required.
Please submit your resume, indicating Requisition Code 3060170223, to Charles Sergent at csergen1@ITS.JNJ.com. EOE M/F/D/V.
United States-Pennsylvania-Spring House
Janssen Research & Development, LLC. (6084)
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