Nonclinical Toxicologist - Remote

Proclinical is seeking a remote Nonclinical Toxicologist for a global biopharmaceutical company.
This individual will provide oversight and toxicology subject matter expertise to support project nonclinical activities, including managing outsourced nonclinical toxicology studies, protocol development and data interpretation.
Must be eligible to work in the US.
Job Responsibilities

• Serve as the Toxicology functional contributor to key meetings with our project team.
• Contribute to the data interpretation and reporting of study results to the project team.
• Preparation of expert toxicological documentation to support regulatory submissions (medicinal CTDs and responses to regulatory authorities).
• Maintain study files and records using electronic document management systems (eDMS).
• Preparation of toxicological documentation for CDLT review and approval
• Request study quotes from the CROs and align with project team on budget.
• Staying updated on internal policies and SOPs
• Provide Toxicological expertise to support the development of nonclinical toxicology study protocols and data interpretation.
• Be familiar with requirements of regulatory authorities for toxicology studies to support IND and NDA (e.g., ICH and OECD guidelines).
• Ensure team awareness as to the significance of results from toxicology studies and recommend consequential course of action to clarify issues relevant to project development.
• Work with internal contract managers to implement study contracts.
• Single point of Toxicology contact between pharma and CROs.

Skills And Requirements

• Life Science Degree - PhD in Toxicology preferred
• Fluent in spoken and written English is a prerequisite
• Minimum of 5 years of experience in conducting/monitoring nonclinical toxicology studies

If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at (+1) 267-846-2026 or [email protected].
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
Proclinical Staffing is an equal opportunity employer.
INDSCIC