In this key role he/she will serve as the Advanced Modelling and Simulation/Pharmacometric Expert. 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.
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.
- Accountable for scoping and delivering the pharmacometric strategy for assigned projects
- 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
- Providing analyses to support the recommendations for clinical doses and dosing algorithms to the clinical and Development teams and in regulatory documentation.
- Accountable for providing advanced mechanistic modelling support for evaluation of key assets, prior to candidate selection
- 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.
Functional scientific skills, including;
- Physiological and biochemical understanding
- Mathematical/statistical skills
- Therapeutic Expertise
- Experience in pharmacokinetics/pharmacodynamic modelling
- Non Linear Mixed Effects Modeling
- 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….)
- Berkeley Madonna
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 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
Job Segment: Biochemistry, Neurology, Physiology, Immunology, Statistics, Science, Healthcare, Data
This job is posted by UCB.
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