The position of Senior Pharmacometrician will report to the Head of Pharmacometrics in the department of Clinical Pharmacology and Pharmacometrics (CPP) at CSL. This role will lead pharmacometric contributions (including pharmacokinetics and PK/PD) for multiple projects at pre-clinical or clinical stages. The Senior Pharmacometrician will also provide input to the pharmacometric strategy for projects, regulatory submissions, or interactions with authorities. The Senior Pharmacometrician works in parallel with Clinical Pharmacologists, Translational medicine experts, Clinicians, and other partner functions, at a project level to align and set pharmacometrics strategy. This role will also assist in interactions with external consultants or with academic institutions.
Main responsibilities and accountabilities
- Contribute to the implementation of model-informed drug development (MIDD) 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, preclinical-to-clinical translational modeling, meta-analyses, disease and systems biology modelling on a project level within R&D
- With guidance, implements the use of innovative quantitative methods in Pharmacometrics/Data Science/ Machine learning (ML)/ Artificial Intelligence (AI) to integrate knowledge of pharmacokinetics, pharmacodynamics, biomarker, patient characteristics and disease states in support of optimal drug development
- 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
- Contributes to or writes Modeling & Simulation Analysis Plans and Reports. Provides input for standard operating procedures, initiatives and best practices in pharmacometrics for the Clinical 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 & biomarker 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
- 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, species scaling methodologies and derivation of first-in-human doses, disease modelling, systems biology, and meta-analyses).
- A minimum of 3 years for Senior Pharmacometrician, specifically contributing to pharmacometrics aspects of clinical drug development.
- Knowledge of advanced PK and PK/PD, specifically in one of the following core sub-specialty: Disease Models, Physiological-Based Pharmacokinetic (PBPK) Models, Exposure-Response(E-R) Models, Systems Pharmacology.
- Working knowledge and significant experience using data analysis software such as NONMEM, R, WinNonLin, SAS, MATLAB, 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, 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.
- 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.
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About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
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