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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 Development Teams (CDTs) to complete safety and risk sections of the prescribing information.

• Participate in due diligence activities on potential Licensing and Acquisition (L&A) opportunities.

Qualifications:

• A minimum of a Master’s 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 6 years of pharmaceutical/biotech industry experience in pre-clinical safety assessment supporting discovery/development with a Master’s degree or a minimum of 3 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.

• Broad understanding of the drug discovery/development process is required.

• Experience with different therapeutic modalities, such as small molecules, peptides, bi-specific antibodies, RNA-targeting therapeutics, cell-based therapy, and/or gene therapy, is preferred.

• Experience representing toxicology/nonclinical safety on matrix project teams is preferred.

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

• Must have excellent 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 https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

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