Pharmacometrician
The Pharmacometrician will:
•Contribute to the implementation of model-based drug development strategies assigned R&D projects as appropriate.
•Implement all necessary hardware and software systems, together with relevant quality processes, for the conduct of in-house pharmacometrics activities
•Contributes to or undertakes all relevant pharmacometric analyses: non-compartmental PK, PK/PD analyses, population PK and PK/PD, modelling and simulation methods, meta-analyses, disease and systems biology modelling on a project level within R&D
•With guidance, implement the use of innovative analytical methods in pharmacometrics/modelling and simulation to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states in support of optimal study designs
•Provide pharmacometrics contributions to regulatory documents including Investigator Brochures, Labelling and those required for regulatory meetings and regulatory filings. Provides resolution of pharmacometrics queries from regulatory agencies, taking a lead role in writing and reviewing responses to regulatory queries
•Contribute to or write Modeling & Simulation Analysis Plans and Reports. Provides input for standard operation procedures and best practices in pharmacometrics for the Early Development function
•If required, provide technical support to Research in the development of preclinical PK/PD model required for early clinical development strategy, as well as utilizing Pharm-Tox data appropriately to make clinical dosing decisions.
•Analyze and interpret all study PK, PK/PD and pharmacometric outcomes. Ability to create PK/PD files according to standard specifications and to generate tables and listings as required
•Develop external alliances with consultants, contract organizations and academic institutions to ensure timely conduct of all pharmacometrics deliverables for projects, to continually keep abreast of the science, as well as development of more junior colleagues in the discipline
Requirements:
Education:
• Doctoral degree with demonstrated expertise in pharmacometrics and strong quantitative skills (e.g. proven experience in most of the following areas: population and PK/PD modelling, mechanistic modelling, systems biology, species scaling methodologies and derivation of first-in-human doses, disease modelling and meta-analyses).
Experience:
•A minimum of 1 year experience of pharmaceutical industry (or relevant) experience for the Pharmacometrician position, specifically contributing to the pharmacometrics aspects of clinical drug development.
•Knowledge of advanced PK and PK/PD, specifically in one of the following core sub-specialty: Systems Pharmacology, advanced Exposure-Response Models, Disease Models, Physiological-Based Pharmacokinetic Models
•Working knowledge and experience of software such as NONMEM, SAS, S-Plus, R, WinNonlin, and other server-based data processing and modelling tools
•Knowledge and application of statistics, random effects modelling, mixed effects modelling, data mining, population PK/PD analyses and modelling (including nonlinear models), Bayesian methods, clinical utility indices, and Monte-Carlo simulation
• Ability to understand and implement all aspects of pharmacometrics needs across a variety of disease areas
Competencies:
•Excellent communication skills with demonstrated ability to effectively present any aspect of this highly technical field, as well as its plans/strategies, accordingly to various audiences in both verbal and written form.
•Excellent oral presentation skills.
•Ability to conduct, and communicate pharmacometrics plans/strategies and analyses.
•Ability to create publications according to international scientific standards.
•Good interpersonal skills, including a positive and constructive attitude and ability to effectively work in a team matrix environment. Negotiation and influential skills advantageous.
Worker Type:
Employee
Worker Sub Type:
Regular
