Principal Scientist, Nonclinical Safety Lead

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. As a Principal Scientist, Nonclinical Safety Lead, you collaborate with innovative and diverse scientists to support projects across multiple therapeutic areas and modalities. You provide toxicology leadership for all aspects of discovery and development projects, and work across stages of development, therapy areas, and modalities. Principal Responsibilities Represent NCS on global discovery and development project teams, serving as the single point of contact within NCS 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 Minimum of a Master’s degree in Toxicology, Pharmacology, or a related discipline. Preferred: Doctoral degree (PhD, DVM, MD or equivalent) in Toxicology, Pharmacology, or a related discipline. Minimum of 6 years of pharmaceutical/biotech industry experience in pre‑clinical safety assessment supporting discovery/development with a Master’s degree, or minimum of 3 years of such experience with a doctoral degree. Broad understanding of the drug discovery/development process. Experience with therapeutic modalities such as small molecules, peptides, bi‑specific antibodies, RNA‑targeting therapeutics, cell‑based therapy, and/or gene therapy. Experience representing toxicology/nonclinical safety on matrix project teams. Board certification (e.g. Diplomate of the American Board of Toxicology (DABT)) is preferred. Excellent oral and written communication skills. Ability to critically evaluate, interpret and integrate large datasets and literature. Required 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 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 Equal Employment Opportunity Statement 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. #J-18808-Ljbffr 6084-Janssen Research & Development, LLC Legal Entity