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Advanced Modelling & Simulation Expert

Location: 

Braine L'alleud, Walloon Brabant, Belgium

Job Function:  Research & Early Development
Job ID:  67348

Advanced Modelling & Simulation Expert

(Pharmacometrician)

 

Location: Braine l’Alleud, Belgium

 

Role Overview

In this key role he/she will serve as an internally and externally recognised Advanced Modelling and Simulation Expert /Pharmacometrician working within a matrix team supporting early (pre-POC) and late phase (post-POC) projects to deliver and apply quantitative solutions to drive the delivery of the translational and clinical development plan and when required represent modelling and simulation in project teams and regulatory meetings

Working mainly outside the classical clinical/project team frame-work, dealing directly with key individuals (Quantitative Clinical Pharmacologist, Exploratory Statistician, Biomarkers and Therapeutic Experts) to scope the key question/concept, plan a solution, and lead its execution and delivery, providing an answer. 

In particular, he/she will provide specialized pharmacometric expertise to multiple projects,  and will work within a dedicated team along with an external network of experts to support the delivery of analyses, enhance project impact, develop and apply new methodologies and solutions, whilst remaining at the cutting edge in terms of expertise. He/she is expected to provide leadership and help junior members in the team

 

 Main Accountabilities

  • Accountable for scoping and delivering the pharmacometric strategy for assigned projects aligned with clinical development plans
  • Developing disease-based PK-PD models and meta-analyses to support translation, risk assessment through various decision points (FIH, POC to PH3) in the key (Immunology, Neuroscience, Bone) UCB’s therapeutic areas 
  • Support key regulatory and project milestones under key time pressures
  • Providing analyses to support the recommendations for clinical doses and dosing algorithms to the clinical and Development teams and in regulatory documentation.
  • Provide guidance to the quantitative pharmacologist on optimal PK and PK-PD sampling for implementation in the various stages of development, and subsequently perform the population PK and PK-PD analyses (safety and efficacy) on a continuous and live basis as the project progresses.
  • Evaluate the potential use of different technologies and approaches to support project progression e.g. empirical approach, systems pharmacology, sparse methodology
  • Accountable and responsible for key technical reports (e.g. population PK, PK-PD, trial simulations as well as sections of regulatory documents).
  • Initiating and managing collaborations with external experts on either methodological, academic or key project components.
  • Providing support to junior members in the team
     
    Technical Capabilities
    Functional scientific skills, including;
  • Physiological and biochemical understanding
  • Mathematical/statistical skills
  • Therapeutic Expertise
  • Experience in pharmacokinetics/pharmacodynamic modelling
  • Non Linear Mixed Effects Modelling
  • Knowledge of drug development and the application of modelling in the regulatory and decision making setting
  • Proficiency in performing data analysis and interpretation with several pieces of software such as;
  • NonMem and add-ons (PsN, XPose, Pirana, Navigator….)
  • R
  • Phoenix
  • Berkeley Madonna
  • MatLab
     
    Essential Requirements
    Educated to Pharm D or PhD (or equivalent) with demonstrated experience (with examples of impact) in the conduct and application of M&S, preferably in the pharmaceutical industry, consultancy group or academic setting.  This experience can be validated via publication.
  • Effective oral and written communication skills both within the expert domain and effective with non-experts
  • Able to work in a time critical part of the value chain, supporting project milestones and regulatory submissions.
  • Able to deal with multiple project deliverables in parallel and effectively manage time
  • Able to communicate complex modelling concepts and results effectively to other functions and project teams
  • Strong leadership skills
  • Efficient time management and organization skills
  • Ability to work in a matrix team
  • Ability to produce and present quality scientific papers at external meetings and for publication
     
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