Principal Scientist Toxicology

Description

As Principal Toxicologist, this role leads and manages nonclinical safety strategies across multiple drug development projects. The incumbent serves as the primary toxicology representative on interdisciplinary project teams, leads the Nonclinical Expert Team (NCET), and provides scientific leadership from early discovery through regulatory submission and marketing authorization. The role is responsible for the design, adequate budgeting, oversight, monitoring, interpretation, communication, and reporting of nonclinical safety studies conducted internally and externally in GLP and non-GLP environments.

Responsibilities and Accountabilities

·       Serve as the Toxicology representative on cross-functional project teams and act as NCET lead.

·       Act as the Nonclinical Development representative on Research Project teams.

·       Design, adequately budget, oversee, monitor, interpret, communicate, and report nonclinical safety studies conducted internally and externally in GLP and non-GLP environments.

·       Develop and implement toxicology strategies aligned with clinical development plans from early discovery through regulatory submission and marketing authorization.

·       Proactively identify and manage safety risks and liabilities early in development across therapeutic modalities.

·       Prepare toxicological risk assessments supporting drug development, manufacturing, and product quality.

·       Prepare and review nonclinical documents for regulatory submissions and interactions with health authorities.

·       Collaborate with internal stakeholders, including pharmacology, PK, clinical, regulatory, CMC, and Quality teams.

·       Present integrated safety assessment...

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum.

Sed ut perspiciatis unde omnis iste natus error sit voluptatem accusantium doloremque laudantium, totam rem aperiam, eaque ipsa quae ab illo inventore veritatis.