My company shares my passion for helping to improve human health around the world.
"This is My MedImmune" Those who join MedImmune feel a sense of ownership about their future. They thrive with a recognized leader in the biotechnology industry and the wholly-owned subsidiary of AstraZeneca plc. Here, you will join passionate professionals who advance science, technology and medicine to develop products designed to help people live better lives. You will excel in an environment characterized by respect, integrity and growth opportunities... that encourages both individual contribution and collaborative entrepreneurial thinking. Our products and/or product candidates are designed to address areas of need in key therapeutic areas, including oncology; respiratory, inflammation and autoimmunity; cardiovascular and metabolic disease; and infection and vaccines. Explore a MedImmune career as we strive to better more lives, more often, around the world. Title Senior Pharmacometrician / Principal Pharmacometrician Location CA, Mountain View MD, Gaithersburg - Corporate Headquarters Job Description This position can be filled at either the Senior Pharmacometrician or Principal Pharmacometrician level depending upon experience. This position can be based in Mountain View, CA or Gaithersburg, MD. This is a strategic and scientific role within Clinical Pharmacology & DMPK (CPD), which provides nonclinical and clinical PK/PD, pharmacometrics and bioanalytical support for biotherapeutics projects at all R&D stages from discovery research to BLA registration and commercialization. The pharmacometrician will conduct advanced population modeling and stochastic clinical trial simulations for late-stage biotherapeutics projects. In collaboration with clinical pharmacokineticists, statisticians and physicians, the pharmacometrician will work as a partner in cross-functional project teams providing sophisticated M&S support for clinical dose recommendation, optimal trial design, rational development decision making, and regulatory filings. Major Duties and Responsibilities: * Leverage M&S expertise to address key clinical development questions. Provide strategic input into clinical development plans. Responsible for the M&S components in late-stage trial designs and data interpretation. * Use innovative quantitative approaches to integrate knowledge of PK, PD, efficacy, safety, patient demographics, and pathophysiological factors to facilitate product development decision making. Perform mechanistic PK-PD and disease modeling to establish dose-exposure-response relationship. * Contribute to the regulatory submission packages, and participate in regulatory meetings as appropriate. Interact with clinical pharmacokineticists and monitor outsourced modeling activities to ensure quality of the work and timely delivery of the results. * Utilize published external data to enhance the knowledge of diseases and treatments, and to facilitate the development of internal drug candidates. * Actively promote MedImmune as a biopharmaceutical leader in the utilization of quantitative model-based drug development approach. Support MedImmune publication strategy. Present and report data in approved external conferences and scientific/medical journals. Position Requirements Education/Experience Senior Pharmacometrician PhD with 2- 5 years of relevant industry experience in pharmacostatistical data analysis . Principal Pharmacometrician PhD with 5+ years of experience in pharmacostatistical data analysis and regulatory filings. Skills: * Demonstrated expertise in pharmacometrics and strong quantitative skills. * Prior experience in regulatory filings is highly desirable for Sr Pharmacometrician and required for Principal Pharmacometrician * Proven track record of extensive experience in population modeling and simulations using NONMEM. * Familiarity with statistical software package Splus, R or SAS. * Good communication and scientific writing skills, and ability to independently work in a matrix environment. Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation Req ID 11006 Interested candidates please apply online at https://www.medimmune.com/about-us/careers.html# and use Requisition ID 11006. Thanks. To the extent this electronic communication or any of its attachments contain information that is not in the public domain, such information is considered by MedImmune to be confidential and proprietary. This communication is expected to be read and/or used only by the individual(s) for whom it is intended. If you have received this electronic communication in error, please reply to the sender advising of the error in transmission and delete the original message and any accompanying documents from your system immediately, without copying, reviewing or otherwise using them for any purpose. Thank you for your cooperation.
