Director, Toxicology

This job is no longer active. View similar jobs.

POST DATE 9/2/2016
END DATE 12/1/2016

Dart NeuroScience LLC San Diego, CA

Company
Dart NeuroScience LLC
Job Classification
Full Time
Company Ref #
360600
AJE Ref #
576066990
Location
San Diego, CA
Experience
Entry Level (0 - 2 years)
Job Type
Regular

JOB DESCRIPTION

APPLY
Develop and oversee non-clinical safety and toxicology drug development plans for small molecule CNS compounds with estimated costs, timing, and risk assessment/management
Identify and resolve nonclinical study operational issues and maintain project timelines
Develop safety-related issue mitigation or resolution plans and coordinate execution of the experimental plan as required
Interact with CRO s to coordinate, design and monitor GLP and non-GLP toxicology and safety pharmacology studies
Critically review and edit CRO toxicology study reports, analyze and interpret data (e.g., toxicology, DMPK, analytical) and coordinate report finalization
Coordinate cross-departmental activities necessary for the effective conduct of safety assessment studies
Advise discovery project teams on target-based toxicological risks and develop monitoring and testing strategies
Communicate toxicology study findings, including relevance and interpretation, to project teams
Prepare and edit non-clinical documents for regulatory submission (e.g. INDs, IB s, and regulatory briefing documents)
May interact with regulatory agencies on nonclinical matters
Maintains a current understanding of toxicology literature and methodology, as well as the scientific literature related to the specific drug discovery projects
Maintains a current understanding of regulatory requirements and guidances