[NMusers] Wanted: Clinical Research Scientist - Pharmacology, Cambridge MA

Clinical Research Scientist - Pharmacology

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

Primary Responsibilities:

* Design Phase I studies and clinic=
al pharmacology components
in Phase II-IV trials.

Design clinical pharmacology components (pharmacokinetic and
pharmacodynamic) of clinical trials in all phases of devel=
opment.

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

* Working with Clinical Operations, h=
elp develop the
operational strategies for clinical pharmacology studies and =
development
programs - investigator selection, CRO selection, budgets, e=
tc.

* 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 inte=
rfaces.

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 pharmacokinet=
ics and pharmacodynamics
and their integration in the clinical drug development pro=
cess 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 a=
nalyses and
simulation.

* Substantial technical writing experie=
nce is essential -
documented first authorship of protocols, study reports, reg=
ulatory
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, ant=
i-viral) training and
experience are desirable.

* Clinical budget and project managem=
ent skills are desirable.

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

To be considered for this position, please send your res=
ume by email to
<mailto:hr_at_idenix.com> hr_at_idenix.com
<mailto:hr_at_idenix.com?subject=Clinical%20Pharmacologist> , or b=
y mail
to:
Human Resources
Idenix Pharmaceuticals
60 Hampshire Street
Cambridge, MA 02139

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

Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Mass=
achusetts,
is a biopharmaceutical company engaged in the discovery, d=
evelopment and
commercialization of drugs for the treatment of human vira=
l and other
infectious diseases. Our current focus is on the treatment=
 of infections
caused by hepatitis B virus, hepatitis C virus and human=

immunodeficiency virus.

 

 


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Received on Fri Dec 07 2007 - 16:25:03 EST