New opportunity in the bay area of CA available. Full time opportunity with an established client. Job description below. Please contact me at [email protected]<mailto:[email protected]> for more info: This individual will be responsible for the dual development and implementation of both Clinical Pharmacology and Modeling and Simulation (M&S) strategies in support of the company portfolio. Professional Responsibilities:
* Integrate PK, PD, safety, and efficacy data with M&S methodologies, spanning population (PopPK) to quantitative systems pharmacology (QSP) approaches * Will support multiple quantitative clinical pharmacology deliverables, both with hands-on contributions and of work conducted by external vendors * Provide both departmental representation and subject matter expertise on development teams * Author and/or review documents including clinical protocols, M&S analysis plans and reports as well as study reports, regulatory documents, and journal articles * Attend and present at internal and external meetings as needed * Support interactions with worldwide Health Authorities regarding clinical pharmacology issue * Supervise outsourced studies with external vendors Education/Experience: * Ph.D. in Pharmacokinetics, Pharmacometrics, 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 M&S approaches (e.g. 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:[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 [linked logo] <https://www.linkedin.com/in/brenda-roseberry-1608166/?msgConversationId=6641167769234657280&msgOverlay=true>
