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Associate Scientific Director, PK/PD Modeling Job

Company Name:
Janssen Research & Development, LLC. (60
Spring House, PA, US
Johnson & Johnson companies are equal opportunity employers.
Associate Scientific Director, PK/PD Modeling
Description
Janssen Research & Development, L.L.C., a Johnson & Johnson company, is recruiting an Associate Scientific Director to be located in Spring House, PA.
Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson, provides medicines for an array of health concerns in several therapeutic areas, including: attention deficit hyperactivity disorder (ADHD), cardiovascular disease, general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologics (Alzheimer's disease, epilepsy, migraine prevention and treatment), pain management, and women's health. Our ultimate goal is to help people live healthy lives. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market - from patients to practitioners, from clinics to hospitals. For more about Janssen Pharmaceuticals, Inc., one of the Pharmaceutical Companies of Johnson & Johnson, visit
The Associate Scientific Director will conduct advanced PK/PD modeling research with emphasis on disease progression modeling and implementation of mechanism-based approaches. Will support product development as Model Based Drug Development (MBDD) Leader by defining the dose-concentration-pharmacological effect relationships of drugs using modeling and simulation methodologies from data acquired at various stages of drug research and development. Perform basic and clinical disease research, with a focus on Oncology, Immunology and/or Infectious Diseases compounds. Perform population PK and PK/PD analysis for regulatory submissions. The successful candidate uses state-of-the-art computer modeling and simulation techniques to formulate various clinical trial design scenarios and outcome analyses. Will have full technical responsibility for interpreting, organizing, executing, and coordinating assignments. Conceptualize plan, develop and execute R&D projects that have a major impact on key development programs, and acts as the MBDD representative on Clinical and/or Compound Development Teams. Actively maintain relationships and collaborate with colleagues within or outside the MBDD organization and J&J at large. Part of the Associate Scientific Director's time will need to be devoted at establishing and maintaining external collaborations with Academic groups active in Oncology, Immunology and/or Infectious Diseases worldwide. Will be responsible for acting independently on scientific and technical matters pertaining to his/her field, to drive advancing the science in the field, to identify research opportunities and to coordinate them. The successful candidate will serve as senior technical expert for the organization in the application of advanced PK/PD and disease modeling principles, as well as in mechanism-based concepts and processes.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
Qualifications
A minimum of a Master's degree in Pharmaceutical Sciences, Clinical Pharmacology, Chemical/Biomedical Engineering or related discipline with a minimum of 10 years of pharmaceutical development experience in various aspects of modeling and simulation is required OR a PhD in Pharmaceutical Sciences, Clinical Pharmacology, Chemical/Biomedical Engineering or related discipline with a minimum of 6 years of pharmaceutical development experience in various aspects of modeling and simulation is preferred.
Hands-on experiences with population approach in describing PK/PD systems with various types of clinical pharmacology data is required.
Demonstrated experience identifying research projects and successfully managing them in collaboration with internal or external teams is required.
In-depth knowledge of preclinical or clinical pharmacokinetics, drug metabolism, PK/PD modeling principles and statistics is required.
Experience with NONMEM, R and/or other modeling and simulation software is required.
Thorough knowledge of planning, conducting, evaluating and reporting PK/PD studies in R&D is required
The ability to perform basic and clinical disease research, with a focus on Oncology, Immunology and/or Infectious Diseases compounds is preferred.
Excellent communication and interpersonal skills is required.
Experience with biologics drug development is preferred.
Experience working with cross functional teams is preferred.
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Primary Location:
North America-United States-Pennsylvania-Spring House
Organization:
Janssen Research & Development, LLC. (6084)
Job Function:
Pharmacokinetics
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Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
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