Pharmacometrician
In this key role he/she will serve as the Pharmacometrics 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 outside the CST/PST framework with key individuals (Quantitative Clinical Pharmacologist, Statistician, Biomarkers and Therapeutic Experts) to scope the key question/concept, plan a solution, and lead its execution and delivery, providing an answer. You will provide specialized (and recognized) advanced modelling skills to multiple projects, and will work within a dedicated team, enhance project impact, develop and apply new methodologies and solutions, whilst remaining at the cutting edge in terms of expertise.
The Responsibilities
- Accountable for scoping and delivering the Pharmacometrics components of assigned projects
- Developing disease-based PK-PD models and meta-analyses to support translation, risk assessment through various decision points (candidate selection, FIH, POC to PH3) e.g. RA, Psoriasis, Parkinson’s Disease, Alzheimer’s and Epilepsy
- Providing analyses to support the recommendations for clinical doses and dosing algorithms (including drug interaction advice, food effects, special group dosing etc) 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, PBPK and PK-PD analyses (safety and efficacy) on a continuous and live basis as the project progresses.
- Accountable for the Pharmacometrics activities to support the design and analysis of early phase (to POC) by delivering a translational and quantitative framework for use within the clinical development team, with the purpose of conducting clinical trial simulations to evaluate design, dose and regimen selection, sample-sizing and optimal delivery of key decisions (e.g Phase I b or II doses and regimen).
- Provide a quantitative evaluation of the potential for DDI in the clinical setting using approaches such as PBPK, to support therapeutic dose choice, and assessment of project risk.
- Provide expertise in the evaluation and prediction of receptor occupancy/target engagement.
- 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).
- Mentor and coach junior pharmacometricians including review of the strategy, technical code and documents.
Skills and Education Requirements
- Functional scientific skills, including:
- Physiological and biochemical understanding
- Mathematical/statistical skills
- Therapeutic Expertise
- Experience in pharmacokinetics/pharmacodynamic modelling
- NonLinear Mixed Effects Modeling
- Knowledge of drug development and the application of modelling in the regulatory and decisionmaking setting
- Super-User software proficiency in performing data analysis and interpretation within softwares such as:
- Pheonix
- R or SAS
- MatLab
- Berkeley Madonna
- Monolix
- NonMem and addons (Census, PsN, XPose, WFN….)
The role holder brings to the expert group, a specialist and recognized advanced skill set that can be tapped on and is available to multiple projects. Key pharmacometrics skills are required to evaluate the implementation of novel and innovative methods of key pre-clinical and clinical data for decision making.
Our Offer
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.
