Principal Scientist, Pharmacometrics Support Full-time

Principal Scientist, Pharmacometrics Support

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.

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.

Location: Beerse, Antwerp, Belgium

Purpose: This position is responsible to support the Pharmacometrics Leader (PML) or Clinical Pharmacology Leader (CPL) who is the modeling lead in development and execution of Pharmacokinetic/Pharmacodynamic (PK/PD) Modeling and Simulation activities related to the 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. The Pharmacometric (PM) support team is mainly passionate about data programming, data quality control (QC), analysis QC and e-submission related aspects and process improvements.

You will be responsible for:

• Preparing R programming scripts to generate non-linear mixed effect modelling (NONMEM) analysis input dataset(s) for PK, PK/PD or Exposure Response analysis, based on requests from PM leader or Modeling leader.
• Generating Analysis Dataset Non-Compartmental Analysis (ADNCA) input datasets and associated Data Transfer Agreements and metadata.
• Upon request, QC NONMEM or ADNCA input dataset(s) generated by another PM support colleague. Log which QC script is used, which subjects were checked per study, what other aspects were checked within the dataset, the findings of the QC and the follow-up actions of those findings in a QC document.
• Generating e-submission package for NONMEM (or other modelling type) analysis. In general, the package includes NONMEM input datasets, NONMEM control file, output parameter files, output table files and other files, in addition to supporting documents such as define and var-names-descr files. PM support renames the files provided by PM leader or CPP leader, so they fit the naming convention requirements for e-submission package if needed, converts these files into the appropriate formats and places them into the right folder structure then links them to the define and var-names-descr files. PM support works closely with EPOD team to ensure the e-submission package has the right structure, accurate formats and being placed in the right assembly server directory.
• Interacting with other departments (including but not limited to Data Management, Clinical & Statistical Programming, bio-analytical teams, Regulatory) and external Vendors to communicate the needs of CPP in data collection, data formatting, data representation and cross departmental trainings if needed. Promote better understanding across different departments.
• 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 (e.g. a standard QC R script with a checklist), pharmacometric analysis QC procedures and e-submission package preparation; move forward existing automatizations ensuring high quality and speed.
• Overseeing internal R package updates and maintenance. Creating required training decks for internal use. Actively participating in working groups related to AI assisted code generation.
• Presenting (cross-departmental) process improvements within/outside the department.
• Carrying out functional responsibilities in accordance with applicable SOPs and Regulatory requirements.

Qualifications / Requirements:

Education:

• A minimum of a Bachelor's degree in Pharmaceutical Sciences, Clinical Pharmacology, Chemical/Biomedical Engineering or a related field with 8+ years of pharmaceutical development experience; or 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 is required.

Experience and Skills:

Required:

• Expertise with R programming language and R function creation is required.
• A fundamental understanding of clinical drug development and PK & PK/PD population PK modeling concepts is required.
• Good understanding of regulatory requirements and eCTD is required.
• Good understanding of AI driven approaches within data programming is required.
• Data-handling skills and solid understanding of clinical database structures such as SDTM and ADAM is required.
• Excellent written and oral communication skills with strong attention to detail are required.
• Ability to build and improve working relationships inside and outside the department; ability and willingness to work in a cross-functional team environment (building strategic working relationships) is required.
• Ability to collaborate in a diverse global environment is required.
• Self-motivation with the ability to work independently with minimal direction is required.

Preferred:

• R Shiny programming experience is preferred.
• Prior knowledge with ADNCA and ADPPK dataset standards is preferred.
• Knowledge of principles of non-linear mixed effect modeling is preferred.
• Prior experience with pharmacometric analysis QC would be an asset.
• Experience within oncology and immunology is an asset.