Provides expertise in Toxicology to project teams for assigned projects. Effectively and efficiently outsources Toxicology studies and other related activities for assigned projects. Provides publication-ready documentation for the Toxicology components of regulatory submissions for assigned projects.
Provides Toxicology expertise and advice to project teams and Biosciences management for assigned projects.
Proposes programs of work for Biosciences management approval.
Actively contributes to resolution of Toxicology issues, minimizing any impact on project timelines
Manages outsourced Toxicology programs at CROs for assigned projects, under the direction of the Head of Toxicology.
Ensures that data are reported to agreed timelines and to XXXXX documentation standards.
Efficiently communicates findings and their relevance to project teams, as agreed with Biosciences management.
Proposes study designs within generic departmental guidelines, ensuring appropriate cross-functional input is received.
Ensures consistent high standards of science and quality are applied to the design and conduct of Toxicology studies and that the data generated are valid.
Assess the competencies and capabilities of Toxicology vendors, ensures appropriate legal contracts are in place, monitors vendor performance to ensure best value for XXXXXX.
Key Competencies:
A sound basic knowledge of regulatory Toxicology guidelines, study designs and methodologies.
A sound basic knowledge of the drug development process.
Excellent interpersonal, organizational and team-working skills.
Effective oral and written communication.
The ability to propose innovative Toxicology programs and ideas to resolve issues.
Programs of work should be agreed with the relevant Project Teams and Toxicology Head, as should significant deviations from plan (costs, timelines, strategic direction)
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