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Job Opportunities at Pharmacometrics Alexion

From: tong shen <shent1997>
Date: Tue, 1 Dec 2020 13:44:56 +0000

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, wit=
h up to 20% travel required



Position Summary

Associate Director, PK-PD Modeling and Pharmacometrics (PMX) position is r=
esponsible, as a PMX project leader, for developing and executing Modeling&=
Simulation (M&S) plans and strategies and exposure response analyses for co=
mpounds 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 cr=
oss functional drug discovery and development project teams in close collab=
oration with colleagues in Clinical Pharmacology, Translational Medicine, M=
edical Sciences at various TAs, Biostatistics, Research and other colleague=
s within Alexion R&D organization. This position will participate in the ac=
tivities to strengthen the PMX and Modeling capability within Alexion by co=
ntributing to the continuous improvement of pharmacometric technical skills=
et, computational infrastructure and the strategic use of M&S methodologies=
 across our projects and disease areas, and optimizing the utility of exter=
nal PMX resources.

This position will also be responsible for his/her project related M&S assi=
gnments either executed independently, or under supervision or in collabora=
tion with external PMX CROs. This position will

  1. Develop and execute population PK, PKPD, exposure response, dose sele=
ctions for phase 3 strategies/plans and corresponding models for the pharma=
cometric function from early clinical studies to Phase IV studies
  2. Develop the quantitative system pharmacology strategies/plans and cor=
responding models for target identification, and compound design/characteri=
zation, translation from preclinical to FIH dose selection;

The incumbent will be responsible for the preparation of population PK/PD r=
eports and corresponding regulatory submission documents. The incumbent wil=
l be expected to manage multiple development projects simultaneously, and w=
ill 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 overal=
l preclinical and clinical plans;
  * By using state of the art M&S methodologies strongly contribute to de=
cision making at critical milestones based on quantitative principles in cl=
ose collaboration with Biostats, Clin Pharm, Medical Sciences, Research, an=
d other quantitative disciplines;
  * Lead an internal matrix team(s) in building quantitative systems biol=
ogy/pharmacology (QSP) models to support the activities from early discover=
y to FIH and beyond, in collaboration with leading external QSP service pro=
viders;
  * 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 submiss=
ion 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 soft=
wares or computing platform;
  * Well versed at plotting complex data to identify trends important for=
 drug development;
  * Track record of applying quantitative system pharmacology methodologi=
es 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 e=
ngineering, or clinical pharmacology is desired.


If you need more information, feel free to contact me tong.shen


Received on Tue Dec 01 2020 - 08:44:56 EST

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