Senior Scientist, Pharmacometrics

Johnson Johnson; Raritan (NJ); On-site; USD 140,000 - 190,000; Full time

Job summary

Johnson & Johnson is seeking a Senior Scientist, Pharmacometrics to lead population PK/PD modeling and exposure–response analyses across compounds in development. You will plan, analyze, and report pharmacometric results to support dose finding and regulatory interactions.

The role requires a PhD or MS with relevant experience, strong programming in NONMEM/Monolix and R, and the ability to communicate complex results clearly. Domestic and international travel about 5% is anticipated.

Qualifications

• Ph.D. or MS in pharmaceutical sciences or related fields.
• Experience in pharmacometrics modeling and simulations.
• Knowledge of regulatory submissions and scientific writing.

Responsibilities

• Conduct population PK, PD, ER analyses to inform dose regimen and study design.
• Write analysis plans and reports, define data requirements, perform QC.
• Manage pharmacometrics deliverables in a matrix environment; meet timelines.
• Contribute to new methodologies and software validation.

Skills

PK/PD modeling

Pharmacometrics analyses

Regulatory submissions writing

Communication skills

Education

Ph.D. in Pharmaceutical Sciences or related field

MS with 2+ years experience

Tools

NONMEM

Monolix

R

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

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.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource

If you are under 18 years of age you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to