Mid level clinical pharmacology role available in the bay area. Please email me at [email protected]<mailto:[email protected]> for more info. (permanent, full time salary and benefits provided, relocation is also provided if needed)
This position will assist in developing and applying clinical pharmacology and translational medicine strategies for candidate drug products from first in human through late stage development (Phase 3 and NDA/BLA filings) using PK, PD, DMPK, scientific acumen and knowledge of drug development processes along with regulatory guidance. Key skills and responsibilities include: * Representing clinical pharmacology department on cross-functional project teams * Collaborate with other disciplines for the optimal design of Phase I-IV studies; including clinical study protocols and reports. * Collaborate with the bioanalytical team for the proper collection and testing of relevant PK/biomarker samples. * Assist in the preparation of clinical pharmacology reports and regulatory documents (IND, IMPD, IB, NDA CTD, etc). * Perform data analysis such as non-compartmental and compartmental PK/PD analysis. * Work closely with pharmacometricians * Contribute to the writing of publications and making scientific presentations consistent with development strategies. * Maintain knowledge of relevant scientific and regulatory practices and trends, and ensure that clinical pharmacology aspects of development programs are contemporary. Other duties as assigned. A PhD or PharmD in a scientific discipline is required. A minimum of 3 years work experience in an industry research and/or development environment is required. Post-doctoral work may serve as experience. Exceptional non-PhDs may also be considered. Must be able to demonstrate significant success in technical knowledge and ability, scientific creativity, collaboration with other scientists and independent thought. Must be able to clearly communicate scientific and technical information both written and verbally. Must be able to demonstrate sound judgment and problem-solving capabilities. Strong organizational skills are required. Experience working in an FDA regulated environment and experience and understanding of ICH, and GCP is highly desired. Must have hands-on experience with data analysis, non-compartmental and compartmental PK/PD analysis and using data processing software such as Phoenix WinNonlin, R, NONMEM, and/or MONOLIX. Good working knowledge of graphing software is also desired. [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]] <https://www.linkedin.com/in/brenda-roseberry-1608166/?msgConversationId=6641167769234657280&msgOverlay=true>
