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At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub** **Function:

Nonclinical Safety

Job Category:

Scientific/Technology

All Job Posting Locations:

Spring House, Pennsylvania, United States of America

Job Description:

About Innovative Medicine:

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for a Senior Principal Scientist, Developmental and Reproductive Toxicology (DART)** **to be onsite in Spring House, PA.

A pre-identified candidate for consideration has been identified. However, all applications will be considered.

Purpose:

The Senior Principal Scientist, Developmental and Reproductive Toxicologist (DART), in Nonclinical Safety and Submissions (NCSS), a department in the Preclinical Sciences and Translational Safety (PSTS) organization, functions as a scientific subject matter expert, providing guidance on DART and juvenile toxicity strategy, risk assessment, and communication across various therapeutic areas. The position involves application of the 3Rs through leveraging existing data/knowledge for weight-of-evidence approaches and exploring NAMs in lieu of in vivo studies.

You will be responsible for** **:

+ Provide subject matter expertise in reproductive, developmental, & juvenile toxicology to global multi-disciplinary teams within PSTS supporting drug development programs and due diligence activities.

+ Prepare DART target risk assessments and guide DART and juvenile toxicity strategy for biologics, small molecules, and other modalities.

+ Maintain up-to-date knowledge regarding innovative approaches in (predictive/alternative/NAMs) DART research and possibilities to support DART risk assessment.

+ Prepare DART-related sections for health authority submissions, (i.e., marketing authorizations, pediatric plans, briefing books detailing weight-of-evidence approaches) and responses to questions.

+ Design of DART and juvenile toxicity studies for various modalities in alignment with ICH guidance documents.

+ Oversee and monitor contracted DART and juvenile toxicity studies in compliance with Good Laboratory Practices (GLPs) and animal welfare regulations, following company policies and standard operating procedures.

+ Integrated scientific data interpretation and critical report review for DART and juvenile toxicity studies.

+ 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 developmental/reproductive toxicity in molecular pathways and propose appropriate follow-up.

+ 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 toxicology, pathology, bioanalysis, toxicokinetics, and development project leaders in the US, Belgium, and China.

+ Demonstrate expertise within the field of specialization through publications, presentations, active engagement in teratology or toxicology societies and/or contributions to external consortia.

Qualifications / Requirements:

Education and Years of Experience:

+ Minimum of a Bachelor’s degree is required

+ PhD in Toxicology or closely related discipline (e.g. Biomedical Sciences) is highly preferred

Required:

+ Minimum of 8 years of experience in Developmental and Reproductive Toxicology

+ Minimum of 4 years of experience with the nonclinical drug development process

+ Expertise with ICH-guideline DART and juvenile toxicity study designs, study conduct, integrated scientific data interpretation, and GLP regulations

+ 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

+ Prior experience in scientific data evaluation, integrated safety assessment, and scientific writing

+ Personal leadership skills, a pro-active and flexible attitude, sense of urgency and excellent collaboration and inclusive team relationships skills

+ Ability to travel to monitor toxicology studies on-site placed at contract laboratories in US and Canada (up to 10% travel)

Preferred:

+ Experience with written regulatory interactions in support of drug development

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

\#LI-Hybrid

Required Skills:

Preferred Skills:

Clinical Data Management, Drug Discovery Development, EHS Compliance, Emergency Planning, Performance Measurement, Presentation Design, Process Hazard Analysis (PHA), Process Optimization, Program Management, Regulatory Affairs Management, Research and Development, Risk Management, Safety Audits, Safety Investigations, Safety-Oriented, Scientific Research, Strategic Thinking, Tactical Planning, Technical Credibility