Position Summary:

Strategically plan, design, implement and monitor nonclinical toxicology and safety pharmacology studies to support MGI PHARMA’s product development goals.

Duties & Responsibilities:

Develop and review study protocols, evaluate cost proposals and study timelines, select appropriate Contract Research Organizations to conduct studies
Interact with Contract Research Organization personnel, monitor ongoing studies and evaluate study data as it is being generated
Review, analyze, interpret and summarize toxicology data and present salient findings to the project team
Review and evaluate toxicology study reports for completeness and accuracy; provide study report evaluation to the Contract Research Organization for report finalization; conduct Contract Research Organization site visits and study monitoring visits
Manage the preparation and present scientific data in internal and external forums
Provide interpretation of salient toxicological findings on drug development projects to the project team, regulatory agencies and other internal and external arenas
Conduct/coordinate scientific reviews of internally and externally generated nonclinical data

Minimum Requirements:

Ph.D. with 2-5 years of experience or B.A./M.A. with 5 or more years of experience as a toxicologist
Familiar with GLP regulations and ICH/FDA guidelines for nonclinical toxicology studies
Experience working with Contract Research Organizations
Excellent verbal and written communication skills
Strong interpersonal communication skills

NOTE: This job description is not intended to be all-inclusive. Associate may perform other related duties to meet the ongoing needs of the organization.

An Equal Opportunity Employer

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