We are looking a highly motivated individual who will be able to
design, simulate, analyze, and interpret of clinical pharmacology and
biopharmaceutic studies, pharmacokinetic and pharmacodynamic components
of late phase clinical trials, and write study reports for regulatory
submissions. The candidate should able to provide appropriate input for
the Clinical Pharmacology section of INDs and/or NDAs; provide input on
clinical pharmacology related issues to project teams; respond to
inquiries from regulatory authorities; coordinate and collaborate with
colleagues in bioanalytics, biometrics, clinical development, drug
metabolism and pharmacokinetics, and toxicology for the conduct and
interpretation of clinical studies.
The candidate must have at least 3-5 years of post-doctoral experience
in pharmaceutical industry, regulatory agency, and / or academia; and
should be familiar with the requirements of the design, conduct,
analysis and report writing for regulatory submissions. Excellent
understanding of drug metabolism and PK/PD principles is required.
Candidates must have ?hands-on? experience in the conduct and data
analysis of clinical PK/PD studies, using various pharmacokinetic
software programs. Familiarity with the design, conduct and analysis
of preclinical, clinical pharmacology and bioequivalence is essential.
Experience in population PK/PD analysis (and clinical trial
simulation) using software programs such as NONMEM (and the Pharsight
Trial Simulator) is highly desirable. S-Plus and/or SAS experience
would be an added plus. Experience with Unix and PC-based platforms
are required. The individual must be able to work with minimal
supervision, and demonstrate a willingness to learn.
The interested candidate should have a Ph.D. in Clinical Pharmacology,
Pharmaceutical Sciences or Pharmacology with emphasis on
Biopharmaceutics and Pharmacokinetics, Applied Mathematics /
Statistics, Biochemical / Chemical Engineering.
Interested candidates should send their CVs to:
Ene I. Ette, Ph.D., FCP, FCCP
Sr. Dir. / Head of Clinical Pharmacology
Vertex Pharmaceuticals, Inc.
Cambridge, MA 02139
Tel.: 617-444-6318
Fax.: 617-444-6713
email: ette@vrtx.com
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