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Author employment -- Drug Development Manager
Roxanne

2005-07-25, 6:57 pm

Our client is a bio-pharmaceutical research company, located in Ottawa,
Canada, specializing in a unique "charge control" molecular
technology. This technology has applications in treating heart disease,
cancer, and infectious disease, the world's three biggest health care
markets.

The company is entering Phase II human trials with CRD5, a drug which
has shown strong potential to raise HDL, lower triglycerides, and
stimulate reverse cholesterol transport.There is ongoing pre-clinical
development of additional drug candidates.

We are currently seeking an experienced Drug Development Manager to
take on broad responsibilities related to taking our drug candidates
into and through human clinical trials. The job involves advising
scientific staff during pre-clinical and clinical phases of drug
development on experimental design to facilitate regulatory
submissions, designing pharmacokinetic and toxicology studies,
recommending and executing clinical trial strategy, designing trial
protocols, preparing submissions, acting as the primary interface with
regulators, regulatory consultants, and CROs, overseeing manufacture of
active pharmaceutical ingredient and drug product, and managing
execution of trials.
The successful candidate should have a PhD and significant experience
in a pharmaceutical development company. Experience with therapeutic
drug development and strong scientific background in drug formulation,
pharmacokinetics and toxicology are required. Familiarity with
regulatory environment in Canada, U.S., and Europe is essential.

A competitive salary commensurate with experience and qualifications
is offered, a dynamic and flexible work environment, as well as the
opportunity to participate in the growth and equity of an exciting new
Canadian company.

Candidates with the requisite qualifications and experience Please
contact Roxanne@spi.ca or 613.234.8503 ext 226

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