modeling, with the aim to guide effective translation and development of clinical programs. Additional responsibilities may include pharmacometrics modeling and simulation activities for ClinPharm-sponsored and -supported studies for products in any phase of clinical development; the generation and review of clinical pharmacology and Pharmacometrics documents related to regulatory submissions, preparing responses to Agency questions and preparing for and/or attending meetings with Regulatory Agencies and Advisory Committee Meetings.
Key Responsibilities :
Support high impact product development projects in all stages of drug development using mechanism and physiologically-based PK/PD modeling & simulation methodologies, including Quantitative Systems Pharmacology (QSP) modelling, PBPK modelling, disease progression modelling and landscape analysis, etc.
Demonstrate high proficiency in the development and application of models to address drug-discovery and development questions
Perform exploratory modelling projects with quick turnaround to support critical business decisions
Provide leadership to and collaboration with multidisciplinary project teams to develop and apply QSP models
Supervise and actively participate in the review and monitoring of outsourced modeling activities conducted at Contract Research Organizations (CROs)
Guide and supervise junior scientists in the group
• Serve as a point-of-contact person on QSP project teams, work in close collaboration with key Therapeutic Area stakeholders, clinical teams and related functional groups to maximize the value of mechanistic and QSP modeling.
• Provide scientific and strategic expertise across therapeutic areas (Immunology, Oncology, Cardiovascular & Metabolism, Neuroscience, Infectious Diseases) and promote model-informed drug discovery and development strategies
Ph.D. degree in Pharmaceutical Sciences, Systems Biology/Pharmacology, Mathematics, Engineering, or other disciplines related to quantitative pharmacology or equivalent
• At least 5 years of experience in using quantitative approach in describing biological systems and demonstrated ability to apply quantitative tools to enable rational and efficient drug development
• Excellent understanding of theory, principles and statistical aspects of advanced mathematical modeling and simulation, including numerical methods, parameter estimation/optimization, and ordinary differential equations (ODEs), and how these can be applied in the development of complex models of biological pathways and systems
• Proficient in at least one advanced PKPD modeling and simulation software (e.g. Matlab/Simbiology, Julia, Python, NONMEM, Monolix, etc.)
• Self-motivated team player who excels in a collaborative, multi-disciplinary team environment
• Good oral and written communication skills and the ability to interact effectively with scientists in other disciplines with a positive, collegial and collaborative attitude.
• Experience in building, validating and using QSP models or deterministic models of biological pathways/systems to support basic science and/or translational clinical research strongly preferred
Good understanding of the basic principles of pharmacokinetics and pharmacodynamics for conventional large and small molecule therapeutics as well novel therapeutic modalities
• Experience with general programming and data analysis tools/languages such as R would be particularly desirable
• Strong publication record highly desirable
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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
Eligible for benefits to include medical, dental, vision and time off as well as any others as provided for in the applicable Collective Bargaining Agreement.
For additional general information on company benefits, please go to: - https://https://www.careers.jnj.com/employee-benefits