Alexion Pharamcometrics is actively looking for talents. Multiple positions are open. Here is one of job listing for AD, and there are also Sr manager, Director and Sr Director opportunities. Job Listing Detail
This position may be based at any Alexion US office, or virtual/remote, with up to 20% travel required Position Summary Associate Director, PK-PD Modeling and Pharmacometrics (PMX) position is responsible, as a PMX project leader, for developing and executing Modeling&Simulation (M&S) plans and strategies and exposure response analyses for compounds from the early stage (first-in-human up to proof-of-concept) to the late-stage clinical development (proof-of-concept up to post market) in cross functional drug discovery and development project teams in close collaboration with colleagues in Clinical Pharmacology, Translational Medicine, Medical Sciences at various TAs, Biostatistics, Research and other colleagues within Alexion R&D organization. This position will participate in the activities to strengthen the PMX and Modeling capability within Alexion by 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, or under supervision or in collaboration with external PMX CROs. This position will 1. Develop and execute population PK, PKPD, exposure response, dose selections for phase 3 strategies/plans and corresponding models for the pharmacometric function from early clinical studies to Phase IV studies 2. Develop the quantitative system pharmacology strategies/plans and corresponding models for target identification, and compound design/characterization, translation from preclinical to FIH dose selection; The incumbent will be responsible for the preparation of population PK/PD reports and corresponding regulatory submission documents. The incumbent will be expected to manage multiple development projects simultaneously, and will participate in discussions and presentations to senior management. Principal Responsibilities * As M&S project lead in one or more cross functional 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; * Strengthen and build Alexion internal M&S capability on a continuous basis by attending trainings, evaluating and introducing new M&S tools and computing platform as appropriate; * Prepare population PK/PD reports and corresponding regulatory submission documents. Qualifications * 5+ years pharmaceutical industrial and/or postdoctoral experiences in the related disciplines of clinical pharmacology, PKPD, and QSP; * Excellent hands-on knowledge in R and/or SAS, NONMEM; * Excellent knowledge in Mathlab, Mathmatica, 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 publishing M&S work; * Experience from pharmacometric approaches in hematology, nephrology, metabolic, and neurological disorders and rare diseases preferred; * Excellent written and verbal communication skills; Education * A PhD, degree or equivalent in quantitative sciences, background in engineering, or clinical pharmacology is desired. If you need more information, feel free to contact me tong.s...@alexion.com
