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]] <http://www.linkedin.com/profile/view?id=19937880&authType=name&authToken=b5d_>
