Senior Toxicologist

Job Responsibilities

• Represent toxicology on global research and development project teams communicating non-clinical safety assessment strategy.
• Cook up cross-department execution of the experimental plan including program budgets, and timing of toxicology studies in relation to regulatory and clinical milestones.
• Work with study monitoring group to coordinate, design, monitor, and report toxicology and safety pharmacology studies at contract research organizations.
• Communicate toxicology study findings, including relevant interpretation, to project teams and management.
• Contribute to non-clinical sections of regulatory documents including IND and NDA submissions.
• Maintain currency with GLP regulations and ICH, FDA and EMEA non-clinical safety guidelines.
• Stay updated with the latest scientific developments by reading the current literature and attending conferences.

Job Requirements

• Advanced degree (e.g. PhD, DVM) in pharmacology, toxicology or closely related biological science along with 3-5 years relevant pharmaceutical industry experience, or Master’s Degree + ≥ 10 years relevant pharmaceutical industry experience.
• Experience in designing, monitoring and interpreting non-clinical safety studies.

Qualifications

Advanced degree (e.g. PhD, DVM) in pharmacology, toxicology or closely related biological science along with 3-5 years relevant pharmaceutical industry experience, or Master’s Degree + ≥ 10 years relevant pharmaceutical industry experience.

Skills

Thorough understanding of GLP regulations and FDA/EMEA/ICH nonclinical safety guidelines.

Benefits

Not specified.

Pay

$128,600.00 - $210,000.00 annually.

Schedule

Not specified.