Company Overview
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. Learn more at jnj.com.
Inclusive Workplace
As guided by Our Credo, we are responsible to our employees worldwide. We provide an inclusive work environment where each person is considered as an individual, respecting the diversity and dignity of our employees and recognizing their merit.
Job Function
Discovery & Pre‑Clinical/Clinical Development
Job Sub‑Function
Pharmacokinetics & Pharmacometrics
Job Category
Scientific/Technology
All Job Posting Locations
High Wycombe, Buckinghamshire, United Kingdom
Job Description
About Innovative Medicine: Our expertise 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.
This role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all postings, we recommend focusing on the specific country(s) that align with your preferred location(s).
Belgium – Requisition Number: R‑064042
United States – Requisition Number: R‑062478. Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
Purpose
This position supports the Pharmacokinetics/Pharmacodynamics (PK/PD) modeling lead in development and execution of PK/PD modeling and simulation activities related to research, design, implementation, data analysis, interpretation, reporting, and publication of Clinical Pharmacology and Pharmacometrics (CPP) sponsored and –supported studies for products in any phase of development.
You Will Be Responsible For
* Preparing R programming scripts to generate non‑linear mixed effect modelling (NONMEM) analysis input datasets for PK, PK/PD or Exposure Response analysis, based on requests from the PM leader or modeling lead.
* Generating analysis dataset Non‑Compartmental Analysis (ADNCA) input datasets and associated Data Transfer Agreements and metadata.
* Conducting QC on NONMEM or ADNCA input datasets generated by another PM support colleague, documenting findings and follow‑up actions.
* Generating e‑submission packages for NONMEM (or other modelling type) analysis, ensuring correct file naming, formatting, and structure in collaboration with the EPOD team.
* Interacting with other departments (Data Management, Clinical & Statistical Programming, bio‑analytical teams, Regulatory) and external vendors to communicate CPP data needs and cross‑departmental training.
* Piloting the generation of the first draft AI‑Authored data specification.
* Performing pharmacometric analysis QC activities in support of the PM leader.
* Driving CPP internal process improvements in dataset creation, dataset QC, pharmacometric analysis QC procedures and e‑submission package preparation.
* Overseeing internal R package updates and maintenance, creating required training decks for internal use, and actively participating in AI‑assisted code generation working groups.
* Presenting process improvements within and outside the department.
* Carrying out functional responsibilities in accordance with applicable SOPs and regulatory requirements.
Education and Qualifications
* Minimum of a Master’s degree in Pharmaceutical Sciences, Clinical Pharmacology, Chemical/Biomedical Engineering, or a related field with 6+ years of pharmaceutical development experience OR a PhD with 4+ years of pharmaceutical development experience.
Experience and Skills – Required
* Expertise with R programming language and R function creation.
* Fundamental understanding of clinical drug development and PK & PK/PD population PK modeling concepts.
* Good understanding of regulatory requirements and eCTD.
* Good understanding of AI‑driven approaches within data programming.
* Data‑handling skills with solid understanding of clinical database structures such as SDTM and ADAM.
* Excellent written and oral communication skills with strong attention to detail.
* Ability to build and improve working relationships inside and outside the department, and willingness to work in a cross‑functional team environment.
* Ability to collaborate in a diverse global environment.
* Self‑motivation with the ability to work independently with minimal direction.
Experience and Skills – Preferred
* R Shiny programming experience.
* Prior knowledge with ADNCA and ADPPK dataset standards.
* Knowledge of principles of non‑linear mixed effect modeling.
* Prior experience with pharmacometric analysis QC.
* Experience within oncology and immunology.
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.
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