Overview
At Johnson & Johnson, health is everything. Our strength in healthcare innovation aims to prevent, treat, and cure complex diseases, with treatments that are smarter, less invasive, and more personal. Through Innovative Medicine and MedTech, we innovate across the full spectrum of healthcare solutions to deliver tomorrow’s breakthroughs and impact health for humanity. Learn more at jnj.com.
This role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you may apply to any postings, focus on the country(s) that align with your location.
Location
Beerse, Antwerp, Belgium
Job Details
Job Function: Discovery & Pre-Clinical/Clinical Development
Job Sub Function: Pharmacokinetics & Pharmacometrics
Job Category: Scientific/Technology
About Innovative Medicine
Our expertise in Innovative Medicine is informed by patients whose insights fuel our science-based advancements. Visionaries work on teams that save lives by developing medicines of tomorrow. You will join us in developing treatments, finding cures, and guiding the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine.
Role Purpose
This position supports the Pharmacometrics Leader (PML) or Clinical Pharmacology Leader (CPL) in the modeling, design, analysis, interpretation, reporting, and publication of CPP studies for products in any development phase. The PM support team focuses on data programming, data QC, analysis QC, and e-submission process improvements.
You Will Be Responsible For
* Prepare R scripts to generate NONMEM analysis input datasets for PK, PK/PD, or Exposure-Response analyses, based on requests from the PM/CPP leaders. Modify the variable definition file as needed for dataset documentation. Datasets may be interim (uncleaned) or final SDTM/ADAM formats, possibly requiring extensive data cleaning and complex calculations.
* Generate Analysis Dataset Non-Compartmental Analysis (ADNCA) input datasets and related metadata and Data Transfer Agreements.
* On request, QC NONMEM or ADNCA input datasets created by other PM colleagues. Record QC actions, subjects checked, and follow-up actions in a QC document.
* Generate e-submission packages for NONMEM or other modeling analyses, including input datasets, control files, output files, and supporting documents. Rename and convert files to meet submission conventions and ensure correct folder structure and links to define/var-names-descr files; coordinate with the EPOD team for correct structure and formatting.
* Collaborate with Data Management, Clinical & Statistical Programming, bio-analytical teams, Regulatory, and external vendors to align on data collection, formatting, and cross-department trainings as needed; promote cross-department understanding.
* Pilot the first draft AI-authored data specification.
* Conduct pharmacometric Analysis QC activities in support of the PM Leader.
* Drive internal CPP process improvements in dataset creation and QC, pharmacometric analysis QC, and e-submission packaging; advance existing automation to improve quality and speed.
* Oversee internal R package updates and maintenance; create training decks for internal use; participate in groups related to AI-assisted code generation.
* Present process improvements cross-departmentally and ensure responsibilities align with SOPs and regulatory requirements.
Education, Qualifications & Requirements
* Master’s degree in Pharmaceutical Sciences, Clinical Pharmacology, Chemical/Biomedical Engineering or related field with 6+ years of pharmaceutical development experience; or PhD with 4+ years of experience.
Experience & Skills
* Expertise with R programming and function creation.
* Fundamental understanding of clinical drug development and PK/PKPD population PK concepts.
* Understanding of regulatory requirements and eCTD.
* Understanding of AI-driven approaches within data programming.
* Data-handling skills and knowledge of SDTM and ADAM data structures.
* Excellent written and oral communication with attention to detail.
* Ability to collaborate in a cross-functional, diverse global environment; strong relationship-building skills.
* Self-motivated and capable of working independently with minimal direction.
Preferred
* R Shiny programming experience.
* Knowledge of ADNCA and ADPPK data standards.
* Knowledge of non-linear mixed effect modeling concepts.
* Experience with pharmacometric analysis QC.
* Experience in oncology and immunology.
Required / Preferred Skills
Skills: Clinical Data Management, Clinical Pharmacology, Clinical Trials Operations, Coaching, Consulting, Critical Thinking, Drug Development, Drug Discovery, Pharmacokinetics, Pharmacology, Pharmacometrics, Program Management, Report Writing, Research, Scientific Research
#J-18808-Ljbffr