Principal Scientist, Toxicology

6084-Janssen Research & Development Legal Entity•Spring House, PA

4d•Hybrid

About The Position

This Principal Scientist in Nonclinical Safety and Submissions, a department in the Preclinical Sciences and Translational Safety (PSTS) organization within Johnson & Johnson Innovative Medicine, supports nonclinical safety evaluation in late discovery and development for various therapeutic areas. You will be responsible for: Design of in vivo general toxicology studies for biologics, small molecules, and other modalities. Integrated scientific data interpretation and critical report review for general toxicology and safety pharmacology studies. Oversee and monitor contracted in vivo toxicology and in vitro/in vivo safety pharmacology studies in compliance with Good Laboratory Practices (GLPs) and animal welfare regulations, following company policies and standard operating procedures. Engagement in multi-disciplinary teams within PSTS and close collaboration with nonclinical project representatives to provide scientific and technical expertise on drug development programs. Participate in issue-resolution teams through active engagement in scientific discussions and the shaping of strategies designed to support and inform critical development decisions. Provide strong scientific input regarding potential mechanisms of toxicity in molecular pathways and propose appropriate follow-up. Maintain up-to-date knowledge regarding innovative approaches in toxicological research. Work independently, foster constructive cross-functional collaborations with both internal and external partners, and be able to prioritize workload in alignment with pipeline priorities. Adhere to timelines; proactively identify and communicate study-related issues and develop contingency plans. The candidate will contribute to the success and growth of PSTS through active participation in internal and external committees / working groups and will closely interact with scientists in other functional areas including pathology, bioanalysis, toxicokinetics, and development project leaders in the US, Belgium, and China.

Requirements

Minimum of Master’s Degree in biomedical sciences, toxicology, pharmacology, or similar education is required.
A minimum of 5 years of relevant experience is required.
Experience as a Study Director or Study Monitor conducting/overseeing in vivo toxicology studies supporting projects in discovery through development is required.
Knowledge of major species typically evaluated as toxicology models is required.
Strong written and verbal communication skills and the ability to negotiate and influence decision-making processes, think and manage issues to resolution, and contribute to study teams and scientific discussions are required with prior experience in scientific data evaluation, integrated safety assessment, and scientific writing.
Capable of making fast decisions when necessary, while maintaining positive and inclusive team relationships, is required.
Personal leadership skills, a pro-active and flexible attitude, sense of urgency and excellent collaboration skills are required.

Nice To Haves

PhD is preferred.
Knowledge in immunology or immunotoxicology is preferred.
Strong critical thinking skills and a strong scientific knowledge in toxicology, safety pharmacology, pathology, and drug metabolism/pharmacokinetics, and an ability to apply this knowledge to influence development programs are preferred.

Responsibilities

Design of in vivo general toxicology studies for biologics, small molecules, and other modalities.
Integrated scientific data interpretation and critical report review for general toxicology and safety pharmacology studies.
Oversee and monitor contracted in vivo toxicology and in vitro/in vivo safety pharmacology studies in compliance with Good Laboratory Practices (GLPs) and animal welfare regulations, following company policies and standard operating procedures.
Engagement in multi-disciplinary teams within PSTS and close collaboration with nonclinical project representatives to provide scientific and technical expertise on drug development programs.
Participate in issue-resolution teams through active engagement in scientific discussions and the shaping of strategies designed to support and inform critical development decisions.
Provide strong scientific input regarding potential mechanisms of toxicity in molecular pathways and propose appropriate follow-up.
Maintain up-to-date knowledge regarding innovative approaches in toxicological research.
Work independently, foster constructive cross-functional collaborations with both internal and external partners, and be able to prioritize workload in alignment with pipeline priorities.
Adhere to timelines; proactively identify and communicate study-related issues and develop contingency plans.
Contribute to the success and growth of PSTS through active participation in internal and external committees / working groups and will closely interact with scientists in other functional areas including pathology, bioanalysis, toxicokinetics, and development project leaders in the US, Belgium, and China.