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Senior Director, Pharmacometrics--Massachusettes

From: Brenda Roseberry <broseberry>
Date: Wed, 15 Aug 2018 17:12:27 +0000

Pharma client is looking for an experienced Director/Sr. Director to estab=
lish and lead quantitative pharmacology and PK/PD modeling and simulation f=
unction within the company. The ideal candidate is a skilled modeler that=
 posseses strong understanding of the drug discovery and development proces=
s; is able to effectively apply quantitative approaches and advanced model=
ing and simulation methods and apply to dose selection and forward decision=
s. Please email me at broseberry> for more info.
Summary of responsibilities

  * Develop quantitative models, and implement translational PK/PD, popu=
lation pharmacokinetic and exposure-response analyses
  * Will be pharmacometric in house expert and promote the value of model=
ing and simulation in the company and to other disciplines and upper manage=
  * Generate capabilities for effective implementation of pharmacometric =
analyses for various small molecule/biologics programs at preclinical and c=
linical stages
  * Report and interpret modeling and simulation analyses results, and co=
ntribute to clinical regulatory documents (study protocols, clinical study =
reports, regulatory submissions, investigator's brochure, etc.)
  * Responsible for up to date knowledge of regulatory expectations, sect=
ions of document prep, and meetings with regulatory authorities
Basic requirements:

  * PhD or equivalent degree with at least 10 years experience, will cons=
ider an MS with considerable experience
  * Proficiency in quantitative analyses (including population PK, PK/PD,=
 exposure-response, drug-disease modeling, and clinical trial simulations
  * Extensive hands-on experience with modeling software such as S-PLUS/R=
, NONMEM, WinNonlin Phoenix, PDx-Pop etc.
  * Experience in integration of preclinical research and clinical drug d=
  * comprehensive understanding of the principles of pharmacokinetics and=
 pharmacodynamics and advanced mathematical modeling and simulation
  * Proven ability in problem-solving, and make positive impact on drivin=
g project decisions using modeling and simulation approaches
  * Previous managerial experience of PhD level scientists is highly desi=
  * Excellent written and verbal communication skills and is able to expl=
ain complex and detailed information in a manner suitable for recipient to =
understand and apply appropriately
  * Experience in regulatory submissions.

  Brenda Roseberry
   Division Manager-Scientific
   Preclinical/Clinical--PK, Pharmacology, Pharmacometrics, Biomarkers, Bio=
    720-328-9526 - Office
    315-415-4353 - Mobile
    720-475-1176 - Fax

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Received on Wed Aug 15 2018 - 13:12:27 EDT

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