Senior Scientist, Pharmacometrics

Johnson & Johnson•Raritan, NJ

12d•Onsite

About The Position

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.

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.
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.

Nice To Haves

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

Responsibilities

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.
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.