Job Function: Discovery & Pre-Clinical/Clinical Development
Job Sub Function: Pharmacokinetics & Pharmacometrics
Job Category:Scientific/Technology
All Job Posting Locations:Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America
Job Description:Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine
We are searching for the best talent for Senior Scientist, Pharmacometrics.
The Senior Scientist position is responsible for the execution of population pharmacokinetic [PK], pharmacodynamic [PD], and exposure-response (ER) modeling and simulation activities related to the planning, analysis, and reporting, for compounds in development. Additional responsibilities include the authoring of pharmacometrics documents related to regulatory submissions, preparing responses to Agency questions and for meetings with Regulatory Agencies and Advisory Committee Meetings.
With oversight, the Senior Scientist can execute the day-to-day operations for the pharmacometric analyses of the assigned programs.
You will be responsible for:Accountabilities with oversight from senior members of the group: - Conduct population PK, PD, ER analyses to inform dose regimen selection and other key drug development decisions, support the design of clinical studies and model-informed drug development plans, and to support regulatory submissions.
- Write analysis plans & reports, define data requirements, conduct analyses, and perform quality control (QC) checks.
- Work effectively in a matrix environment, managing pharmacometrics deliverables in accordance with timelines and overall project goals.
- Contribute to the development of new methodology and/or applications of pharmacometrics.
Other Accountabilities & Tasks:- Present internally and at external scientific meetings; prepare and publish manuscripts in peer reviewed scientific journals; may participate in special interest groups within professional societies.
- Assist in process improvement initiatives, software validation and other technology improvements.
- Carry out functional responsibilities in accordance with applicable SOPs, departmental processes and Regulatory requirements, and Johnson & Johnson Credo principles.
Education and Experience Requirements: - Ph.D. degree or equivalent, in Pharmaceutical Sciences, Pharmacometrics, Chemical/Biomedical/Bio- Engineering or Biological Sciences; M.S. Degree, with 2+ years of experience.
Minimum Technical Knowledge and Skills:- Basic knowledge of PK & PK/PD modeling and simulation (pharmacometrics) concepts and methods.
- Knowledge of modeling software (NONMEM and/or Monolix, R).
- General understanding of the overall drug development process.
- Good oral and written communication skills.
- Estimated both domestic and international travel of about 5% of time.
Required Skills:Preferred Skills:Analytical Reasoning, Clinical Data Management, Clinical Pharmacology, Clinical Trials Operations, Coaching, Critical Thinking, Drug Discovery Development, Empowering People, Pharmacokinetic Modeling, Pharmacokinetics, Pharmacology, Pharmacometrics, Program Management, Report Writing, Scientific Research, Technologically Savvy
The anticipated base pay range for this position is :$109,000.00 - $174,800.00
Additional Description for Pay Transparency:
