Principal Scientist, Reproduction Toxicology
Senior Principal Scientist-Reproduction Toxicology
Locations: Beerse, Belgium
Functions: Toxicology Research
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Requisition ID: 1905769168W
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 and influenza is our passion. In this endeavor, we are seeking to recruit a Senior Principal Scientist, Reproduction Toxicology (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.
In this position, you will lead the development of reproduction toxicology plans and strategies to advance the nonclinical involvement to drug innovations and safety assessments by using deep expertise in reproduction toxicology and nonclinical R&D sciences.
The responsibilities of the Senior Principal Scientist, Reproduction Toxicology include a.o.:
* Proficiency in DART study designs, conduct and integrated scientific data interpretation
* Profound experience in juvenile toxicity studies in rodents as well as non-rodents.
* Proven experience in pharmaceutical industry.
* Demonstrated knowledge of mechanisms of toxicity and its relevance to development of safe medicines.
* Proficiency in presentation, writing and communication techniques.
* Support of projects in answering questions from regulatory authorities.
* 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) DART toxicological research.
* Connect and engage strategically with external partners e.g. CRO, regulators, consortia, professional scientific societies and academia to identify trends in and opportunities of innovations in the reproduction toxicology R&D.
* Perform Target Liability Assessment and conduct in-house mechanistic studies and or monitor outsourced studies according to the guidelines of the various Health Authorities and in compliance with Discovery Data Integrity (DDI) principles.
* Work across the global Nonclinical Safety organization and interface effectively among the multiple multi-disciplinary teams to build early development strategies and de-risking approaches.
PHD in Toxicology or closely related discipline e.g. Biomedical Sciences.
*15 + years of experience in Developmental and Reproductive Toxicology (DART).
*Recognized expert knowledge within the field of DART and pathways analysis.
*Profound understanding of CRO type of work and business relationship.
*Ability to effectively communicate and interact with staff members, stakeholders and (CRO) partners is a must.
*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.
*Possess skills to lead study teams with contributions from various functional areas.
*Comprehensive knowledge of the (Non)clinical drug development process.
*Significant understanding of pharmacokinetics/pharmacodynamics.
*Knowledge of compound chemistry for small as well as large molecules and the biology of targets.
*Able to successfully interact in cross-functional teams.
*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)