Principal Scientist Pmetrics

Johnson & Johnson Co.; Beerse; On-site; EUR 80,000 - 138,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Job summary

Johnson & Johnson is seeking a Principal Scientist in Pharmacometrics to lead population PK/PD and exposure‑response analyses for compounds in development. You will author pharmacometrics documents for regulatory submissions and support inquiries from Regulatory Agencies and Advisory Committees.

With guidance, you will develop Model Informed Drug Development plans and manage day‑to‑day pharmacometric analyses, contributing to new methodologies and process improvements.

Qualifications

• Ph.D. in Pharmaceutical Sciences or related field with 2+ years post-doc or MS with 4+ years relevant experience.
• Working knowledge of PK/PD modeling and pharmacometrics concepts.
• Hands-on experience with pharmacometrics software (NONMEM and/or Monolix, R).
• Understanding of drug development process including MIDD and regulatory guidelines.

Responsibilities

• Conduct population PK, PD, ER analyses to inform dose regimen and regulatory submissions.
• Write analysis plans and reports, define data requirements, perform QC and interpret PK/PD data.
• Work in a matrix environment and manage pharmacometrics deliverables to timelines.
• Present findings at meetings and contribute to peer-reviewed manuscripts.

Skills

PK/PD modeling

Regulatory knowledge

Communication skills

Drug development

Education

PhD or MSc in Pharmaceutical Sciences/related field

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.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function

Discovery & Pre-Clinical/Clinical Development

Job Sub Function

Pharmacokinetics & Pharmacometrics

Job Category

Scientific/Technology

All Job Posting Locations

Beerse, Antwerp, Belgium

Job Description

The Principal Scientist Pharmacometrics position is responsible for the co-development and execution of population pharmacokinetic [PK], pharmacodynamic [PD], and exposure-response (ER) modeling and simulation activities related to the planning, implementation, analysis, interpretation, and reporting for compounds in development. Additional responsibilities include the authoring of pharmacometrics documents related to regulatory submissions, preparing responses to Agency questions and contributing to meetings with Regulatory Agencies and Advisory Committee Meetings.

The position is responsible for contributing to the development of Model Informed Drug Development (MIDD) plans with guidance from senior members of the group, clinical pharmacology leaders and other stakeholders. With guidance, the Principal Scientist can execute the day-to-day operations for the pharmacometric analyses of the assigned programs.

You will be responsible for:

Accountabilities with guidance 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, perform quality control (QC) checks, and interpret PK/PD data and results.
• 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, with 2+ years of post-doctoral experience or M.S. degree with 4+ years of relevant experience.

Minimum Technical Knowledge and Skills

• Working knowledge of PK & PK/PD modeling and simulation (pharmacometrics) concepts and methods.
• Hands-on knowledge of pharmacometrics modeling software (NONMEM and/or Monolix, R).
• Understanding of the overall drug development process including MIDD and the Pharmaceutical R&D process.
• Working knowledge of regulatory requirements and guidelines.
• Good oral and written communication skills.

Estimated both domestic and international travel of about 5% of time.

Preferred Skills

Clinical Data Management, Clinical Pharmacology, Clinical Trials Operations, Coaching, Consulting, Critical Thinking, Drug Development, Drug Discovery Development, Organizing, Pharmacokinetics, Pharmacology, Pharmacometrics, Program Management, Report Writing, Researching, Research Proposals, Scientific Research

The anticipated base pay range for this position is

€79 800,00 - €137 770,00

Benefits

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.

Additional information

79 800 00 - 159 600 00 EUR Annual