Janssen Research & Development a member of the Johnson & Johnson Family of Companies is recruiting for a Scientific Director - Pharmacometrics located in Spring House, PA with consideration given to Raritan, NJ.
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.
The Scientific Director, Pharmacometrics is responsible for strategizing the development and execution of pharmacokinetics population pharmacokinetic [PK] and pharmacodynamic [PD] modeling and simulation activities related to the research, design, implementation, data analysis, interpretation, reporting, and publication of studies for products in any phase of development. Additional responsibilities include the generation and review of pharmacokinetics documents related to regulatory submissions, preparing responses to Agency questions and preparing for and/or attending meetings with Regulatory Agencies or Advisory Committee Meetings.
You will be responsible for responsible for supervising and conducting advanced population PK-PD modeling and simulation exercises, and independently contributing to drug development and the advancement of science both internally and externally.
• Strategize, prioritize, coordinate and contribute to the Global Pharmacological Modeling workload for projects in the TA as needed.
• Conducts advanced pharmacokinetic (PK)/pharmacodynamic (PD) modeling and simulation research with emphasis on mechanism-based modeling techniques and disease progression models.
• Supports product development by defining dose-concentration-pharmacological effect relationships of a drug using modeling & simulation methodologies from data acquired at various development stages (Phase 1-3).
• Performs population PK/PD analyses in support of regulatory submissions.
• Develops clinical trial design scenarios and performs outcome analyses using computer simulation techniques, with the goal to advise on clinical trial designs with the highest probability of success.
• Is responsible for identifying, interpreting, organizing, executing and coordinating projects.
• Plans and develops R&D projects with major impact on drug development.
• Serves as technical expert in the application of PK/PD modeling theories, concepts, principles and processes.
• Maintains liaisons within and outside the organization. Represents the organization on scientific matters within the worldwide scientific community.
• A PhD or equivalent in Pharmaceutical Sciences, Clinical Pharmacology, Chemical/Biomedical Engineering or Biological Sciences and a minimum ten (10) years of pharmaceutical development experience in the various aspects of modeling and simulation
• A fundamental understanding of clinical and pre-clinical drug development including clinical pharmacokinetics, drug metabolism, and PK/PD modeling and simulation principles
• Expertise in advanced PK & PK/PD modeling and simulation (pharmacometric) concepts and methods
• In-depth knowledge of pre-clinical and Professional experience in planning, conducting, evaluating and reporting PK/PD/Pharmacometric studies in R&D environment
• Advanced knowledge of non-linear mixed effect modeling
• Expertise in using S-PLUS/R and NONMEM
• Demonstrated internal and external leadership skills in areas related to Pharmacometrics and model-based drug development
• Has established a level of expertise or scientific reputation though multiple publications and presentations. Author or co-author of minimally 10-15 peer-reviewed publications
• Good written and oral communication skills
• Fluent in written and spoken English
• Ability to build and maintain effective working relationships inside and outside the department; ability and willingness to work in a cross-functional team environment
• Ability to multi-task and prioritize assignments, establishing courses of action for self and others to ensure that work is completed efficiently and in a timely manner
• Actively identifying new areas for learning, and application to the job
• Good sense of cultural sensitivity and diversity
• Participates in and/or expands knowledge of Pharmacometrics and related sciences via internal/external presentations, trainings, educational events and/or meetings
• Helps to advance the science in the field, identifies research opportunities and coordinates them, both internally and externally.
• Carries out functional responsibilities in accordance with applicable SOPs/Guidelines and Regulatory requirements
This position is located in Spring House, PA with consideration given to Raritan, NJ and may require up to 10% domestic and international travel.
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-
North America-United States-New Jersey-Raritan
Janssen Research & Development, LLC (6084)