Senior Pharmaceutical Toxicologist – Consulting Leader

BlueRidge Life Sciences; Heber (UT); On-site; USD 150,000 - 230,000; Full time

Job summary

BlueRidge Life Sciences is seeking an experienced toxicologist (15+ years in biopharmaceuticals) to join the ToxStrategies practice. The role involves leading nonclinical safety programs, designing studies, interpreting toxicity data, and coordinating with regulatory authorities on submissions.

The ideal candidate holds a Ph.D. in toxicology, is familiar with ICH guidelines, and can contribute to regulatory strategy and business development. Travel up to 20% may be required.

Qualifications

• Ph.D. in toxicology or related field with extensive drug development experience.
• Experience in pharmaceutical consulting, industry, government, or CROs (15+ years).
• Knowledge of ICH and regulatory guidance for nonclinical development.
• Experience coordinating nonclinical safety programs across all development stages.
• Experience writing regulatory sections and interacting with agencies.

Responsibilities

• Address scientific, regulatory, and business challenges in pharma/biopharmaceutical development.
• Oversee toxicology study design, data interpretation, and safety assessments.
• Act as the toxicology representative on project teams.
• Interact with global regulatory authorities (FDA, EMA, others).
• Write or supervise pharmacology/toxicology sections of regulatory documents.
• Develop study protocols and regulatory submission documents.
• Support due diligence and business development efforts for new projects.
• Travel up to ~20% may be required.

Skills

Toxicology

Pharmacology

Regulatory science

ICH guidelines

Nonclinical safety

Regulatory writing

Project management

Leadership

Education

Ph.D. in toxicology

DABT certification (desirable)

Job description

BlueRidge Life Sciences is seeking an experienced toxicologist (15+ years in biopharmaceuticals) to join the ToxStrategies practice. The role involves leading nonclinical safety programs, designing studies, interpreting toxicity data, and coordinating with regulatory authorities on submissions.

The ideal candidate holds a Ph.D. in toxicology, is familiar with ICH guidelines, and can contribute to regulatory strategy and business development. Travel up to 20% may be required.