Posted on Apr 5, 2021 by Alexion Pharmaceuticals
Director Pharmacometrics (PMX) position is responsible, as a PMX project leader, for developing and executing Modeling&Simulation (M&S) plans and strategies in cross functional drug discovery and development project teams in close collaboration with colleagues in Clinical Pharmacology, Translational Medicine, Medical Sciences, Biostatistics, Research and other colleagues within Alexion R&D organization. This position will play a key role in strengthening the PMX and Modeling capability within Alexion by strongly contributing to the continuous improvement of pharmacometric technical skillset, computational infrastructure and the strategic use of M&S methodologies across our projects and disease areas, and optimizing the utility of external PMX resources.
This position will also be responsible for his/her project related M&S assignments either executed independently (about 30%) or in collaboration with external PMX CROs (about 70%). This position will work on both drug research and discovery space (50%) and clinical development (50%). This position will 1) develop the quantitative system pharmacology strategies/plans and corresponding models for target identification, and compound design/characterization, translation from preclinical to FIH dose selection; and 2) population PK, PKPD, exposure response strategies/plans and corresponding models for the Clinical Pharmacology function from early clinical studies to Phase IV studies. The incumbent will be responsible for the preparation of population PK/PD reports and submission documents.
As M&S project lead in one or more cross functional drug discovery and development teams, develop and execute M&S strategies/plans fully integrated with the overall preclinical and clinical plans;
By using state of the art M&S methodologies strongly contribute to decision making at critical milestones based on quantitative principles in close collaboration with Biostats, Clin Pharm, Medical Sciences, Research, and other quantitative disciplines;
Lead an internal Matrix team(s) in building quantitative systems biology/pharmacology (QSP) models to support the activities from early discovery to FIH and beyond, in collaboration with leading external QSP service providers;
Perform population PK, PKPD-analyses, clinical trial simulations and other model based analyses when appropriate;
Initiate and coordinate outsourced M&S activities on a regular basis;
Mentor and coach junior M&S scientists and junior clinical PKPD scientists;
Strengthen and build Alexion internal M&S capability on a continuous basis by initiating training activities, evaluating and introducing new M&S tools and computing platform as appropriate;
Prepare population PK/PD reports and corresponding regulatory submission documents.
Ten+ years pharmaceutical industrial experiences in the related disciplines of clinical pharmacology, PKPD, and QSP;
Excellent hands-on knowledge in R, S-PLUS and/or SAS, NONMEM;
Excellent knowledge in Matlab, or other QSP related softwares or computing platform;
Well versed at plotting complex data to identify trends important for drug development;
Track record of applying quantitative system pharmacology methodologies in a drug R&D context;
Track record of contributions to INDs, NDAs/BLAs, and various regulatory submissions;
Track record of publishing M&S work
Managerial experience, especially related in CRO personnel management is required;
Experience from pharmacometric approaches in hematology, CVMD, nephrology and neurological disorders and rare diseases preferred; Exposure to rare disease drug development is desired
Excellent written and verbal communication skills;
A PhD, degree or equivalent in quantitative sciences, background in engineering, or clinical pharmacology is desired
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