Senior Pharmacometric Scientist — Model-Informed Drug Dev

African American Talent; Antwerpen; Hybrid; EUR 80,000 - 138,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Well-being reimbursement

Insurance plans

Job summary

Johnson & Johnson in Beerse, Belgium, seeks a Principal Scientist Pharmacometrics to co-develop and execute population PK/PD/ER modeling for compounds in development. You will author pharmacometrics documents for regulatory submissions and participate in meetings with Regulatory Agencies and Advisory Committees.

The role supports Model Informed Drug Development plans under senior guidance and executes day-to-day pharmacometric analyses for assigned programs, with an estimated travel ~5%

Qualifications

• PhD in Pharmaceutical Sciences or related field with 2+ years post-doctoral experience or MS with 4+ years relevant experience.
• Strong PK/PD modeling and simulation knowledge.
• Experience with NONMEM/Monolix and R.
• Understanding of regulatory requirements and MIDD.

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, perform quality control 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.

Skills

Pharmacokinetics

PK/PD Modeling

Regulatory Knowledge

Communication Skills

Education

PhD in Pharmaceutical Sciences

MS in related field

Tools

NONMEM

Monolix

R

Job description

Johnson & Johnson in Beerse, Belgium, seeks a Principal Scientist Pharmacometrics to co-develop and execute population PK/PD/ER modeling for compounds in development. You will author pharmacometrics documents for regulatory submissions and participate in meetings with Regulatory Agencies and Advisory Committees.

The role supports Model Informed Drug Development plans under senior guidance and executes day-to-day pharmacometric analyses for assigned programs, with an estimated travel ~5%