Associate Scientific Director, Pharmacometrics.

Company: Johnson & Johnson
Location: Titusville
Posted on: January 9, 2022

Job Description:

Janssen Research & Development, L.L.C., a Johnson & Johnson company, is recruiting an Associate Scientific Director, Pharmacometrics that can be located at any Janssen facility in the US such as Springhouse, PA, Malvern/Chesterbrook, PA, Raritan, NJ, Titusville, NJ, San Diego/La Jolla, CA, South San Francisco, CA, Boston/Cambridge, MA.

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.

As the Associate Scientific Director, you will develop and implement advanced pharmacokinetic [PK] and pharmacodynamic [PD] modeling and simulation (M&S) activities related to the research, design, implementation, data analysis, interpretation, reporting, and publication of studies for products in any phase of drug development.

You will support product development as Pharmacometrics Leader by defining the dose-concentration-pharmacological effect relationships of drugs using M&S methodologies. You will supervise and conduct pharmacometric analysis and contribute to drug development and the advancement of science both internally and externally with minimum supervision. Additional responsibilities include the generation and review of pharmacometric documents related to regulatory submissions, preparing responses to Agency questions and preparing for and/or attending meetings with Regulatory Agencies or Advisory Committee Meetings.

Responsible For (But Not Limited To)

• Perform basic and clinical disease research, with a focus on Oncology/Hematology (small molecules, biologics, and other novel modalities such as cell therapy and gene-therapy).
• Perform population PK and PK/PD analysis for key dose/regimen selections and regulatory submissions.
• Use innovative computer M&S techniques to formulate various clinical trial design scenarios and outcome analyses.
• Conduct sophisticated PK/PD M&S research with emphasis on mechanism-based modeling techniques, systems biology and disease progression models using data acquired at various development stages or using literate searched data.
• Develop & review study designs, writes analysis plans & reports, analyses and interprets PK/PD data and results.
• Lead pharmacometric outsourced work; Review and supervise outsourced PK/PD related activities.
• Find opportunities and ways to address drug development questions/issues that qualify to be addressed with mixed effects modeling or mechanistic modeling.
• Serve as technical expert for the Pharmacometrics organization in the application of sophisticated PK/PD and disease modeling principles, as well as in mechanism-based concepts and processes.
• Actively maintain relationships and collaborate with colleagues within or outside the Clinical Pharmacology and Pharmacometrics organization and J&J at large
• Help to establish and maintain external collaborations with Academic groups active in a variety of therapeutic areas worldwide.
• Act as a trainer and a mentor of junior staff within the department.
  
  Qualifications
  
  • M.S. degree or equivalent in Pharmaceutical Sciences, Pharmacology, Engineering, Statistics, Data Science, Bioinformatics or Biological Science related field and at least 7 or more years' experience of pharmaceutical development experience in various aspects of modeling and simulation -OR- PhD or equivalent in Pharmaceutical Sciences, Pharmacology, Engineering, Statistics, Data Science, Bioinformatics or Biological Science related field with at least 5 or more years' experience in pharmaceutical industry or academia is preferred
  • Hands-on experiences with population approach in describing PK/PD systems with various types of data is required.
  • In-depth knowledge of at least on of the following areas: preclinical or clinical pharmacokinetics, drug metabolism, PK/PD modeling principles and statistics is required.
  • Experience with at least one of the following software: NONMEM, R, Matlab, Monolix, simCYP and/or other M&S software is required.
  • Detailed 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/Hematology compounds is preferred
  • Experience with biologics drug development is preferred
  • Experiences with Quantitative Systems Pharmacology (QSP) or Machine Learning (ML) is preferred but not required
  • The 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 (planning, organizing and time management) is preferred
  • Self-motivated with the ability to work independently with minimal direction is required
  • The ability to translate creative and innovative ways into the solution of problems and the timely advancement of projects is required
  • Excellent communication and social skills are required
  • Experience working with cross-functional teams is preferred
    
    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.
    
    Primary Location
    
    United States-Pennsylvania-Spring House-Welsh & McKean Roads
    
    Other Locations
    
    North America-United States-Massachusetts-Boston, North America-United States-Massachusetts-Cambridge, North America-United States-New Jersey-Raritan, North America-United States-Pennsylvania-Chesterbrook, North America-United States-Pennsylvania-Malvern, North America-United States-Florida-Titusville, North America-United States-California-San Diego, North America-United States-California-South San Francisco, North America-United States-California-La Jolla
    
    Organization
    
    Janssen Research & Development, LLC (6084)
    
    Job Function
    
    R&D
    
    Requisition ID
    
    2105984937W
    
    

Keywords: Johnson & Johnson, Titusville , Associate Scientific Director, Pharmacometrics., Executive , Titusville, Florida