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Wanted: Clinical Research Scientist - Pharmacology, Cambridge MA

From: Rynak, John <Rynak.John>
Date: Wed, 14 Mar 2007 14:51:43 -0400

Clinical Research Scientist - Pharmacology

Reporting to the Director of Clinical Pharmacology, the Clinical
Pharmacologist will be responsible for leading scientific and strategic
planning, internal and external project communications, and clinical
documentation for NDA-directed clinical development programs for
Idenix's drug candidates with an emphasis on clinical pharmacology
studies..

Primary Responsibilities:

* Design Phase I studies and clinical pharmacology components
in Phase II-IV trials.

Design clinical pharmacology components (pharmacokinetic and
pharmacodynamic) of clinical trials in all phases of development.

* Analyze data, interpret results, and first-author clinical
pharmacology-related clinical documentation, including: clinical
protocols; study reports; abstracts and manuscripts; presentations;
clinical pharmacology components of investigator brochures, other IND
and NDA documents; and various other internal and external documents and
communications, as needed.

* Working with Clinical Operations, help develop the
operational strategies for clinical pharmacology studies and development
programs - investigator selection, CRO selection, budgets, etc.

* Help manage program timelines for clinical pharmacology
components and related matters; and help manage budgets to meet or
exceed time, quality and fiscal objectives.

* Assure cross-functional alignment for Clinical Pharmacology
studies and activities with other functional areas involved in clinical
development programs, within Idenix and at intercompany interfaces.

Requirements:

* Minimum requirement: Pharm.D. or Ph.D. in clinical
pharmacology, pharmacokinetics, biopharmaceutics or a related field)
with 2 or more years of industry experience is strongly preferred.

* A thorough command of pharmacokinetics and pharmacodynamics
and their integration in the clinical drug development process is
essential. The candidate must have demonstrated expertise in the design,
analysis and reporting of clinical pharmacology studies. The candidate
must be competent in the use of industry-standard PK and PK/PD software
for noncompartmental, modeling and population-PK and PK/PD analyses and
simulation.

* Substantial technical writing experience is essential -
documented first authorship of protocols, study reports, regulatory
communications, manuscripts, etc. IND and NDA submission experience is
preferred.

* Familiarity with regulatory issues related to Phase I-IV
clinical research is essential.

* Excellent communication (verbal and written), presentation,
and organizational skills are essential.

* Therapeutic area (anti-infective, anti-viral) training and
experience are desirable.

* Clinical budget and project management skills are desirable.

Idenix offers an excellent benefits package including competitive
salary, equity compensation, major medical insurance, dental insurance,
401(k) plan participation, and group life and disability insurance.

To be considered for this position, please send your resume by email to
<mailto:hr
<mailto:hr
to:
Human Resources
Idenix Pharmaceuticals
60 Hampshire Street
Cambridge, MA 02139

www.idenix.com <http://www.idenix.com>

Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts,
is a biopharmaceutical company engaged in the discovery, development and
commercialization of drugs for the treatment of human viral and other
infectious diseases. Our current focus is on the treatment of infections
caused by hepatitis B virus, hepatitis C virus and h

 


Received on Wed Mar 14 2007 - 14:51:43 EDT

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