Principal Scientist, Nonclinical Safety Lead

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

Johnson & Johnson Innovative Medicine R&D is recruiting for a 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 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 modalities.  In 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:

• Represent NCS on global discovery and development project teams, serving as the single point of contact within NCS to the project team for toxicology expertise and guidance, and as the interface between the project team and senior management.

• Lead the team of nonclinical safety and Pharmacokinetic (PK) scientists (PSTS team) working on a project.  Ensure the smooth transfer of necessary information to functional areas within PSTS in conjunction with the PSTS team.

• Collaborate with multi-disciplinary project teams to de-risk drug candidates and support clinical development.  Provide input to the clinical protocols, informed consent forms, and monitoring based on nonclinical findings, target expression and target risk.

• Create target liability assessments and develop fit-for-purpose plans to screen for and manage potential liabilities of novel therapeutics.

• Develop nonclinical safety strategies for different modalities and/or routes of administration based on an integration of literature, regulatory guidance, and involvement with professional organizations to inform project advancement decisions.

• Analyze results of in silico, in vitro and in vivo toxicology, as well as of safety pharmacology studies and literature data, apply strategic perspective to results, and compile nonclinical safety assessments.

• Within issue-resolution teams, provide key contributions to hypotheses generation.

• Utilize drug development experience to effectively communicate across all levels with internal and external partners, including with global regulatory authorities.

• Be accountable, with limited supervision, for global regulatory nonclinical documents (e.g. IB, CTA/IND, NDA/MAA/BLA, CTD and responses to regulatory agencies) for assigned projects in order to support the start of clinical trials, continued clinical development, and ultimately support registration of NCEs and line extensions.

• Serve on medical safety teams and participate in signal detection analyses and risk mitigation.

• Maintain proactive collaboration with key Chemistry, Manufacturing and Controls  (CMC) functions to ensure the quality of drug substances/products.

• Serve on Global Labeling teams working with the Compound Developmen