Sr. Pharmacometrician/Associate Director, 1040-01B

Vertex Pharmaceuticals Incorporated is a global biotechnology company focused on the discovery, development and commercialization of breakthrough drugs for a range of serious diseases. Our business strategy is to commercialize major new drugs both independently and in collaboration with other pharmaceutical companies.

Sr. Pharmacometrician/Associate Director, 1040-01B

This individual will be responsible for assisting with Vertex Clinical Pharmacology studies and may serve as the key person in the Clinical Pharmacology department for one of the company?s program. Specifically, he/she will analyze PK/PD data from clinical studies (Phase I-IV), using NONMEM, WinNonlin, SPLUS or SAS, and will write reports for regulatory submissions; provide scientific input for Clinical Protocols, clinical development plans, Investigator Brochures, and the Clinical Pharmacology section of INDs and NDAs; and interact with contract research organizations (CROs). Also, he/she will be expected to independently develop clinical pharmacology analysis plans, evaluate clinical trial data using advanced exploratory data analyses techniques, and perform clinical trial simulations and apply novel pharmacometric principles to assigned studies. Supervision of department staff may be required.

Requires a PhD in Pharmaceutics, Clinical Pharmacology, Biostatistics, Chemical Engineering or Mathematical Biology, plus 4-7 years in the pharmaceutical industry or within a regulatory agency. Candidates with more experience will be considered for the Associate Director position. All candidates must have substantial knowledge of the requirements for the design, conduct, analysis, and report writing for regulatory submissions, in-depth understanding of drug metabolism and PK/PD principles, experience working with SPLUS or SAS and NONMEM, and an understanding of clinical trial simulation and integration of PK/PD modeling in drug development. Must have good verbal and written communication skills.

 



We provide a highly stimulating working environment coupled with a high level of professional and intellectual challenge. In addition to competitive salary and benefits, we also offer equity participation and participation in a stock purchase program.

Apply online at www.vrtx.com

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