Sr Principal Scientist, Established Products 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:

Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, 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

Please note that this hybrid role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

Belgium - Requisition Number: R-024114

United States - Requisition Number: R-025131

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

We are searching for the best talent for a Senior Principal Scientist, Established Products Nonclinical Safety Lead, in the Specialized Applied Toxicology (SAT) group within Preclinical Safety and Translational Sciences (PSTS), to be located in either Spring House/Raritan USA, or Beerse, Belgium.

The successful candidate will be employed within our SAT group. SAT is an international and diverse multidisciplinary team of scientists providing end-to-end portfolio specialized toxicology support including genetic toxicology, genomic safety, nonactive substance safety, occupational toxicology, and established product nonclinical safety.

As a member of our team, you will have a dual role. Primarily, you will apply your extensive late-stage drug development experience to serve as a Nonclinical Safety Lead (NCSL) as an ad hoc member of established product (EP) compound development teams providing nonclinical expertise in emerging clinical safety issues, supporting periodic updates for marketed products, and representing PSTS on product labeling working groups. Secondly, you will support the R&D portfolio as a toxicologist in the Nonactive Substance Safety (NASS) group, the role includes providing end-to-end support to the J&J Innovative Medicine (IM) portfolio by delivering high-quality authored safety assessments of cross-modality (small and large molecule) Drug Substance (DS) and Drug Product (DP) impurities/degradants; residual solvents/elemental impurities; excipient toxicology assessments; product contact (manufacturing equipment and primary packaging) and drug delivery system Extractable/Leachable (E/L) toxicology assessments; and drug delivery system product biocompatibility assessments.

Key Responsibilities:

As an EP-NCSL:

• Serve as an ad-hoc member of compound development teams by providing relevant non-clinical expertise (pharmacology/pharmacokinetics/toxicology) to support Safety Management Teams in responding to Health Authority questions pertaining to clinical safety issues.
• Provide input to product specific regulatory documents for marketed compounds (Development Safety Update Reports, Periodic Benefit Risk Evaluation Reports, IND Annual Reports, and Risk Management Plans for Established Products).
• Critically appraise nonclinical literature to be included in periodic safety update reports that can inform the risk/benefit profile of marketed compounds.
• Provide guidance on the nonclinical section of Company Core Data Sheets and Product Label