Pharma client is looking for an experienced Director/Sr. Director to establish
and lead quantitative pharmacology and PK/PD modeling and simulation function
within the company. The ideal candidate is a skilled modeler that posseses
strong understanding of the drug discovery and development process; is able to
effectively apply quantitative approaches and advanced modeling and simulation
methods and apply to dose selection and forward decisions. Please email me at
[email protected]<mailto:[email protected]> for more info.
Summary of responsibilities
* Develop quantitative models, and implement translational PK/PD,
population pharmacokinetic and exposure-response analyses
* Will be pharmacometric in house expert and promote the value of modeling
and simulation in the company and to other disciplines and upper management
* Generate capabilities for effective implementation of pharmacometric
analyses for various small molecule/biologics programs at preclinical and
clinical stages
* Report and interpret modeling and simulation analyses results, and
contribute to clinical regulatory documents (study protocols, clinical study
reports, regulatory submissions, investigator's brochure, etc.)
* Responsible for up to date knowledge of regulatory expectations, sections
of document prep, and meetings with regulatory authorities
Basic requirements:
* PhD or equivalent degree with at least 10 years experience, will consider
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
development
* 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 driving
project decisions using modeling and simulation approaches
* Previous managerial experience of PhD level scientists is highly
desireable
* Excellent written and verbal communication skills and is able to explain
complex and detailed information in a manner suitable for recipient to
understand and apply appropriately
* Experience in regulatory submissions.
[cid:[email protected]]
Brenda Roseberry
Division Manager-Scientific
Preclinical/Clinical--PK, Pharmacology, Pharmacometrics, Biomarkers,
Bioanalysis
720-328-9526 - Office
315-415-4353 - Mobile
720-475-1176 - Fax
[cid:[email protected]]
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