New full time, permanent opportunity with US based client. This is a mixed role in clinical pharmacology and pharmacometrics. Must be able to work with minimal supervision. Please contact me brosebe...@cartermackay.com<mailto:brosebe...@cartermackay.com> or 315-415-4353 for more info or to apply.
* Integrate PK/ PD, safety/efficacy data with M&S methodologies * Support multiple quantitative clinical pharmacology deliverables (hands-on contributions and via oversight of work conducted by external partners) * Provide both departmental representation and subject matter expertise on development teams * Contribute to the authorship and/or review of documents (clinical protocols, M&S analysis plans, study reports, regulatory documents, and journal articles * Attend and present at internal and external meetings * Interact with US and global health authorities * Management of outsourced vendors Education/Experience: * Ph.D. in Pharmacokinetics, Pharmacometrics, Biomedical or Chemical Engineering, Pharmaceutical Sciences, or related discipline * 5+ years (10+ for director position) of industry, regulatory, and/or related post-doctoral quantitative clinical pharmacology experience Professional Requirements: * Demonstrated experience with leveraging PopPK, clinical trial simulation, and/ or QSP modeling to inform drug development * Excellent verbal and written communication skills and interpersonal skills * Strong leadership and project management skills * Hands-on experience with M&S software (e.g. NONMEM, R, MATLAB, and/or SimBiology) * Regulatory filing experience is highly desirable [cid:image001.png@01D63808.00623BE0] Brenda Roseberry Division Manager-Scientific Preclinical/Clinical--PK, Pharmacology, Pharmacometrics, Biomarkers 720-328-9526 - Office 315-415-4353 - Mobile 720-475-1176 - Fax [linked logo] <https://www.linkedin.com/in/brenda-roseberry-1608166/?msgConversationId=6641167769234657280&msgOverlay=true>