Senior Principal Scientist, Nonclinical Safety Lead

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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 & Johnson Innovative Medicine R&D is recruiting for a Senior Principal Scientist Nonclinical Safety Lead within Preclinical Sciences and Translational Safety (PSTS). This position is a hybrid role and will be located in Spring House PA.

As a Senior Principal Scientist Nonclinical Safety (NCS) Lead you will collaborate with innovative and diverse scientists to support projects in our large and varied portfolio that spans multiple therapeutic areas and includes innovative this vital role you will provide toxicology leadership for all aspects of discovery and development projects with flexibility to specialize or work across stages of development therapy areas and modalities. You will also collaborate with discovery scientists to identify and nominate candidate molecules and with development teams to bring these molecules to humans and ultimately through global registration.

Principal Responsibilities :

Lead PSTS project teams of nonclinical safety and Pharmacokinetic (PK) scientists ensuring efficient information transfer within the team.

Serve as the NCS representative for global project teams providing toxicology expertise and interfacing with senior management.

Create target risk assessments and develop plans to screen for and mitigate potential risks; analyze toxicology and safety pharmacology studies contextualizing results for human safety and preparing nonclinical safety assessments.

Contribute to issue-resolution teams by generating hypotheses and investigative strategies.

Accountable for global regulatory nonclinical documents and health authority responses to support clinical trials and compound registrations.

Participate in medical safety teams signal detection analyses and risk mitigation strategies.

Engage in nonclinical safety risk assessments for due diligence of potential L&A opportunities as needed.

Collaborate proactively with Chemistry Manufacturing and Controls (CMC) functions to assure drug substance quality.

Participate in external academic or industry societies and consortia to enhance toxicology strategies and capabilities as needed.

Maintain scientific depth and knowledge in competitive intelligence and regulatory landscapes for assigned projects.

Communicate effectively with stakeholders including regulatory authorities leveraging drug development experience.

Qualifications :

A minimum of a Masters degree in Toxicology Pharmacology or a related discipline is required. Doctoral level degree (PhD DVM MD or equivalent) in Toxicology Pharmacology or related discipline is preferred.

A minimum of 12 years of pharmaceutical / biotech industry experience in pre-clinical safety assessment supporting discovery / development with a Masters degree or a minimum of 8 years of pharmaceutical / biotech industry experience in pre-clinical safety assessment supporting discovery / development with a doctoral level degree (PhD DVM MD or equivalent) is required.

Experience in representing toxicology / nonclinical safety on multi-disciplinary project teams is required.

Strong understanding of the drug discovery / development process is required.

Experience in conducting due diligence activities is preferred.

Previous experience as a Study Director / Study Monitor under Good Laboratory Practice (GLP) regulations is preferred.

Familiarity with various therapeutic modalities is preferred.

Board certification (e.g. Diplomate of the American Board of Toxicology (DABT)) is preferred.

Must have e xcellent oral and written communication skills.

The ability to critically evaluate interpret and integrate large datasets and literature is required.

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 internal employees contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

Required Skills : Preferred Skills :

Required Experience :

Staff IC

Key Skills

Machine Learning,Python,Data Science,AI,R,Research Experience,Sensors,Drug Discovery,Research & Development,Natural Language Processing,Data Analysis Skills,Toxicology Experience

Employment Type : Full-Time

Experience : years

Vacancy : 1