Senior Toxicologist, Pharma Nonclinical Strategy

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

Job summary

BlueRidge Life Sciences' ToxStrategies division seeks an experienced toxicologist (15+ years biopharmaceutical/pharmaceutical experience) to join our expanding pharmacology/toxicology consulting practice.

The role involves designing and overseeing nonclinical safety programs, interpreting data for regulatory authorities, and contributing to IND/CTA and NDA/BLA submissions with leadership across teams.

Qualifications

• Ph.D. in toxicology required; 15+ years in pharma/biopharma consulting or industry.
• Familiar with ICH and regulatory guidance for nonclinical development.
• Experience writing regulatory documents (pre-IND, INDs, BLAs/NDAs).
• Strong leadership, collaboration across multi-disciplinary teams, and client interaction.

Responsibilities

• Oversee nonclinical safety programs across drug candidates.
• Lead study placement, data interpretation, and safety monitoring.
• Serve as toxicology expert on project teams and with regulators.
• Write or supervise pharmacology/toxicology sections of submissions (pre-IND, IND/CTA, NDA/BLA).
• Engage in due diligence and business development activities.
• Travel up to ~20% may be required.

Skills

Toxicology expertise

Regulatory strategy

Project management

Scientific writing

Client communication

Education

Ph.D. in toxicology

DABT certification

Job description

BlueRidge Life Sciences' ToxStrategies division seeks an experienced toxicologist (15+ years biopharmaceutical/pharmaceutical experience) to join our expanding pharmacology/toxicology consulting practice.

The role involves designing and overseeing nonclinical safety programs, interpreting data for regulatory authorities, and contributing to IND/CTA and NDA/BLA submissions with leadership across teams.