HI all, I have a new Sr. Director role in Pharmacometrics available and there is the opportunity to work remotely. Company headquarters are east coast United States. Description is below and please email me at [email protected]<mailto:[email protected]> for more info. Alternatively my cell is 315-415-4353. This is a full time position with salary and benefits. Director level will also be considered.
* Lead the pharmacometrics team and develop modeling and simulation strategy in clinical development projects. * Ensure the timely delivery of translational PK/PD, population PK, and exposure response analyses to address key development questions. * Apply model informed drug development approaches. Will work closely with discovery, CMC, biomarker, preclinical development, clinical development, and pharmacovigilence. * Execute PK/PD modeling and simulation sections in regulatory submissions and represent the Clinical Pharmacology function at meetings with regulatory agencies and health authorities. * Manage outsourced studies * Mentor and supervise junior scientists Knowledge/Skills/Abilities Required * A Ph.D. in pharmaceutical sciences, engineering, or mathematics/statistics with 8 to 15 years of modeling and simulation experience in a pharmaceutical/biotech company * Hand on experiences in developing population PK, PK/PD, disease progression, exposure response, PBPK, and translational PK/PD models * Expert knowledge of PK/PD software (WinNonlin, NONEM, Simcyp, NONMEM, R, SAS and MATLAB etc) * Knowledgeable in the regulatory requirements in IND and NDA * Analytical thinker with excellent critical thinking and problem-solving skills. * Excellent verbal and written communication and skills including the demonstrated ability to develop and deliver effective presentations to senior leadership and with the ability to influence [cid:[email protected]] Brenda Roseberry Division Manager-Scientific Preclinical/Clinical--PK, Pharmacology, Pharmacometrics, Biomarkers 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_>
