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WHAT
IN
Pharmacometrician II
Job
Vertex Pharmaceuticals
US
-
Cambridge,
Massachusetts
Job Code - 1044BR
Position - FULL TIME
Job First Active on: Thursday, November 05, 2009
APPLY TO THIS JOB (You will be applying directly to Vertex Pharmaceuticals for this position!)
JOB DESCRIPTION: Pharmacometrician II
The Pharmacometrician II designs and executes elaborate experiments in support of major clinical pharmacology projects with minimal guidance or mentoring. He/She demonstrates an emerging resourcefulness in running multiple activities concurrently and is able to adapt to new projects quickly and effectively. The Pharmacometrician II commands a broad perspective and a deep knowledge of related disciplines and possesses diverse project experience.
Key Responsibilities:
Collaborates with colleagues in bioanalytics, biometrics, clinical development, drug metabolism and pharmacokinetics, toxicology, and regulatory for the conduct and interpretation of clinical studies. Responds to inquiries from regulatory agencies with supervision. Performs routine analysis of clinical pharmacology data (pharmacokinetic and pharmacodynamic (PK/PD)) from phase 1-4 clinical studies independently. Provides peer-reviewed interpretation of clinical pharmacology data and incorporates any analyses into reports required for regulatory submissions. Provides complex clinical pharmacology input to Clinical Protocols, clinical development plans, Investigator's Brochure and Clinical Pharmacology section of INDs and/or NDAs. Provides scientific and technical input about clinical pharmacology-related issues within project teams as assigned. Develops clinical pharmacology data analysis plans with minimal supervision. May supervise other clinical pharmacology staff. Employs advanced nonlinear mixed effect modeling approaches in the analysis of PK/PD data. Develops and conducts predictive model performance assessments. Writes program and script-based analyses. Designs and conducts peer-reviewed clinical trial simulations. Develops informative sampling designs.
REQUIREMENTS - QUALIFICATIONS: Pharmacometrician II
Demonstrates a highly advanced understanding of the requirements of the design, conduct, analysis and report writing for regulatory submissions. Exhibits ability to independently interpret and integrate preclinical PK/PD information into the design, conduct and analysis of preclinical, clinical pharmacology and biopharmaceutical studies. Demonstrates a more thorough understanding of drug metabolism and PK/PD principles. Proven ability to conduct and analyze more complex clinical pharmacology studies using various PK/PD software programs. Communicates more effectively in verbal presentations and in writing technical reports. Ph.D. (or equivalent degree) and 2 – 5 years of relevant work experience, or M.S. (or equivalent degree) and 7+ years of relevant work experience, or B.S. (or equivalent degree) and 10+ years of relevant work experience.
Vertex Pharmaceuticals Incorporated is a global biotechnology company committed to the discovery and development of breakthrough small molecule drugs for serious diseases. The Company's strategy is to commercialize its products both independently and in collaboration with major pharmaceutical companies. Vertex's product pipeline is focused on viral diseases, cystic fibrosis, inflammation, autoimmune diseases, cancer, and pain. Vertex co-discovered the HIV protease inhibitor, Lexiva, with GlaxoSmithKline.
Vertex Pharmaceuticals
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