Senior Pharmaceutical Toxicology Consultant

BlueRidge Life Sciences; Illinois; On-site; USD 180,000 - 240,000; Full time

Job summary

BlueRidge Life Sciences’s ToxStrategies division seeks an experienced toxicologist with 15+ years in biopharmaceuticals to lead nonclinical safety programs and provide regulatory guidance across development stages. The role involves cross-functional collaboration with toxicology, epidemiology, engineering, and biostatistics teams.

You will design study programs, interpret complex data, write regulatory sections, and engage with agencies such as the FDA/EMA.

Qualifications

• Ph.D. required in toxicology, pharmacology, or related sciences.
• Minimum 15+ years in pharma/toxicology consulting or industry/government.
• Familiarity with ICH and regulatory guidelines for nonclinical development.
• Experience overseeing nonclinical safety programs across development stages.
• Strong written and verbal communication; ability to work independently or in teams.

Responsibilities

• Oversee nonclinical safety assessment programs and study design.
• Interpret safety/TK/PK data and oversee project teams.
• Write/regulate pharmacology/toxicology sections of regulatory submissions.
• Interact with regulatory agencies (FDA, EMA, etc.) and write regulatory documents.
• Travel may be required (up to ~20%).

Skills

Toxicology expertise

Project management

Regulatory writing

Team leadership

Communication skills

Regulatory interactions

Education

Ph.D. in toxicology or pharmacology

Job description

BlueRidge Life Sciences’s ToxStrategies division seeks an experienced toxicologist with 15+ years in biopharmaceuticals to lead nonclinical safety programs and provide regulatory guidance across development stages. The role involves cross-functional collaboration with toxicology, epidemiology, engineering, and biostatistics teams.

You will design study programs, interpret complex data, write regulatory sections, and engage with agencies such as the FDA/EMA.