Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a P rincipal Scientist, Translational Pharmacometrics in Biologics Development Sciences located in Spring House, PA.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

This is an expert modeling-focused position in Janssen BioTherapeutics (JBio), within the department of Biologics Development Sciences, that informs the discovery of biological drug molecules, and drives the preclinical development of new molecular entities (NMEs) through IND/CTA filing. This position will be primarily responsible for serving as a Translational PK/PD Leader on project teams (eg, JBio teams, Compound Development Teams), conducting mechanistic PK/PD studies and providing modeling and simulation support for biologics (including protein, cell, gene and RNA therapeutics), across 5 Therapeutic Areas from discovery to early clinical stages. Using both experimental and computational tools, this individual will enable timely decision-making for early stage biologic programs, and serve as a subject matter expert and a key contact person interacting with stakeholder departments, providing technical and strategic direction in biologics PK/PD to support study designs, compound development plans, and regulatory submissions.

The scope of this position encompasses:

• Independently develops fit-for-purpose mathematical models (eg, PK/PD, mechanism-based, quantitative systems pharmacology) to inform target selection, drug design, modality selection, candidate optimization and selection, and inform clinical study design (including but not limited to human PKPD prediction, first-in-human (FIH) starting dose selection, and efficacious dose projections) through identifying and addressing critical knowledge gaps
• Independently determines and designs critical path experiments and delivers high quality results to effectively drive and inform program decisions
• Represents Biologics Development Sciences in cross-functional project teams and communicates effectively to ensure scientific rigor and state-of-the-art science
• Collaborate closely with biologists, protein engineers, toxicologists, bioanalytical scientists, experimental PK/PD scientists, clinical pharmacologists, and clinicians to advance portfolio programs
• Lead the writing and review of relevant sections of internal and regulatory submission documents for biologics
• Identifies and enhances processes and workflow, develops innovative thinking, contributes to strategic decision making and implements new methodologies when applicable
• Contributes externally to the field (non-profit scientific organizations, committees, consortia, white papers, etc.)
• Mentor junior scientists, and serve as JBio team leader as needed

• A PhD in Pharmaceutical Sciences, Clinical Pharmacology, Biological Sciences, Bioengineering, Chemical Engineering, or Applied Mathematics with at least 5 years of relevant experiences (eg, postdoc, industry); post-graduation is required
• Extensive experience with quantitative approach in describing pharmacology and/or PK/PD (preclinical or clinical),and demonstrated ability to apply quantitative tools to enable efficient drug development are required
• Excellent communication skills, experience working on cross-functional teams, and ability to work independently is required
• Expertise and extensive hands-on experiences in at least one of the industry standard modeling and simulation software (eg, Monolix, NONMEM, Matlab, etc.) is required; proficiency in WinNonlin/Phoenix is preferred
• Broad experience in mechanism-based PK/PD modeling, Quantitative Systems Pharmacology modeling and research of biologic therapeutics is highly preferred
• A strong publication record is strongly preferred