Locations: Beerse, Belgium
Functions: Toxicology Research
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Requisition ID: 1905710552W
Janssen Research & Development seeks to drive innovation and deliver transformational medicines for the treatment of diseases in six therapeutic areas: neuroscience, cardiovascular diseases and metabolism, infectious diseases, immunology, oncology and pulmonary hypertension. In these areas, Janssen aims to address and solve unmet medical needs through the development of small and large molecules, as well as vaccines. The Janssen campus in Beerse (Belgium) has a unique ecosystem covering the complete drug development life cycle, with all capabilities from basic science to market access on one campus. The integrated environment of our campus gives our people the chance to experience many different aspects of drug development throughout their career. It has a successful track record of over sixty years of drug discovery and development and is one of the most important innovation engines of the Janssen group worldwide.
Developing innovative therapeutics to treat diseases like Alzheimer's disease, various types of cancers and infectious diseases like Hepatitis B, influenza is our passion. In this endeavor, we are seeking to recruit a Study Director/Toxicologist (m/f) within the Department of Non-Clinical Safety (NCS). The position will be opened on the Beerse campus, which is the flagship R&D center for small molecules within Janssen, investing over 1 billion euros each year in R&D.
The responsibilities of the Study Director/Toxicologist include a.o.
* Design of early toxicological studies, integrated scientific data interpretation and close collaboration with preclinical representatives.
* Selects the appropriate route, species, dosages, formulations, specimens, and time points after consult with the Nonclinical Project Leader and other contributing lead scientists and investigators.
* Work in a multi-disciplinary team within NCS, and depending on skills and experience, also within the discovery sciences organization.
* Provide strong scientific input with regard to potential mechanisms of toxicity in molecular pathways and propose appropriate follow-up. Maintain up-to-date knowledge with regard to innovative approaches in (predictive) toxicological research.
* Possess skills to lead study teams with contributions from various functional areas.
* Responsible for assuring timely completion and reporting of performed studies including the contribution of the Principal Investigator(s) and/or contributing scientists.
* Conduct in-house studies according to the guidelines of the various Health Authorities and in compliance with Discovery Data Integrity (DDI) principles, as appropriate and that protocols have been followed throughout the study.
* Assures all raw data, documentation, protocols, specimens, and final reports are transferred to the archives during or at the close of the study.
* Assures the integrity of the raw data and consistency of conclusions with raw data.
* The Study Director has the overall responsibility of the study and the final report.
Qualifications and abilities
* Academic degree in Veterinary Medicine, or Biomedical Sciences, Toxicology or similar education.
* Experience as Study Director or Toxicologist is preferred, however candidates with proven interest in investigative and discovery toxicology will be also be considered.
* Ability to perform data interpretation from multi-disciplinary contributions.
* Passion to broaden competences in scientific data evaluation, integrated safety assessment, and scientific writing.
* Make fast decisions if needed, but at the same time inclusive and excellent team player.
* Strong communication and personal leadership skills, pro-active and flexible attitude, sense of urgency, excellent collaborator.
* Experience in the therapeutic areas CNS, Oncology and/or Infectious Diseases & Vaccines is preferred.
* Experience with GLP or other quality systems is preferred.
Janssen Pharmaceutica N.V. (7555)