Janssen Research & Development, L.L.C, a member of Johnson & Johnson’s Family of Companies, is recruiting for Clinical Pharmacology and Pharmacometrics Post-Doctoral Fellow at its Spring House PA, Raritan NJ, Titusville NJ, or La Jolla CA sites.
Janssen Research & Development develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in oncology, immunology, neurologic disorders, cardiovascular/metabolic disorders, and infectious disease. Clinical Pharmacology and Pharmacometrics (CPP) is integrated with Statistics and Decision Science in the Scientific Core of Quantitative Sciences as a single aligned organization as part of Janssen Research & Development. We work in cross-disciplinary Quantitative Sciences teams and apply quantitative principles across the R&D portfolio to enable optimal decision-making at the earliest time point and in the most efficient manner.
The Clinical Pharmacology Post-Doctoral Fellow will be involved in various activities to support Research and Development in areas ranging from preclinical to early/late stage clinical development, including:
Clinical Pharmacology & Pharmacometrics
The Clinical Pharmacology and Pharmacometrics (CPP) department at Janssen R&D (JRD) develops and applies quantitative methodologies (population pharmacokinetics, mixed effects modeling, PK/PD analysis, and disease progression modeling) across all phases of drug development. CPP is sponsoring a Post-Doctoral Fellow in its newly developed Clinical Pharmacology and Pharmacometrics Fellowship Program to train early career professionals who can contribute to our goal of discovering and developing innovative medicines. The Post-Doctoral Fellow will work on one or multiple projects to apply and expand in-house clinical pharmacology knowledge, exposure-response, PK/PD, and/or QSP modeling platforms to inform decision making in drug development such as dose selection, and applying model informed drug development (MIDD) principles. This Post-Doctoral Fellow is expected to have recently finished his/her PhD training. The Post-Doctoral Fellow will work under one or more scientists who will provide mentorship during the 2-year program.
Examples of the activities included in the scope of the position are listed below. Fellow activities will be conducted under the guidance and mentorship of an assigned preceptor:
· Contribute to the development of fit-for-purpose mathematical models (eg, population PK and PK/PD, empirical or mechanism-based PK/PD, quantitative systems pharmacology) to 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 using modeling and simulation approaches
· Apply quantitative methods to integrate knowledge of PK, PD, patient characteristics, disease states, and drug-drug interactions to optimize dose selection, dosage regimens and study designs throughout drug development
· Perform and/or liaise for modeling and simulation analysis of preclinical-clinical data, translational Pharmacokinetics/Pharmacodynamics (PK/PD) data, up to First-in-Human (FIH) and beyond if applicable to guide dose regimen from pre-Proof-of-Concept (POC) and POC studies. Help design Phase I Clinical Pharmacology studies. Contribute to monographs, Investigational New Drug applications (INDs), and other documents to support clinical studies and regulatory findings.
· Develop flexible tools for simulation and simulation visualization tools to support clinical development
· Identify and enhance processes and workflow, develop innovative thinking, contribute to strategic decision making and implement new methodologies when applicable
A PhD in Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, Biostatistics, Engineering, Bioinformatics, Computer Science, Applied Mathematics, Systems Biology, or Computational Biolog.
Must be permanently authorized in the US.
Must have the availability to work full-time (40 hours/week) for a 2 year period.
Demonstrated computational skills related to pharmaceutical or biomedical research, and strong hands-on programming skills in R is required; experiences with additional PKPD modeling tools are desired
Excellent communication skills with an ability to build positive relationships with colleagues from diverse backgrounds and work with senior members and cross-functional teams
Detail-oriented, highly organized, and able to manage multiple tasks
Ability to function in a fast-paced environment and a creative problem solver. Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
United States-Pennsylvania-Spring House-Welsh & McKean Roads
Janssen Research & Development, LLC (6084)