Senior Pharmaceutical Toxicology Consultant

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

Job summary

BlueRidge Life Sciences is seeking an experienced toxicologist with 15+ years in biopharmaceutical settings to join the ToxStrategies division. The role involves designing and overseeing nonclinical safety programs for drug candidates, interpreting safety data, and coordinating with regulatory agencies to support INDs, CTAs, and NDAs.

You will work with toxicologists, epidemiologists, engineers, and biostatisticians on multidisciplinary teams, contributing to study design, regulatory writing,

Qualifications

• Ph.D. in toxicology, pharmacology, or related sciences; DABT certification desired but not required.
• Minimum 15+ years in pharmaceutical consulting, industry, or government.
• Comprehensive understanding of ICH and regulatory guidance for nonclinical development.
• Experience leading nonclinical safety programs through all development phases.
• Strong written and verbal communication; ability to work independently or in teams.
• Active involvement in scientific toxicology organizations with recent activity.

Responsibilities

• Oversee nonclinical safety programs and study placement; interpret safety, TK/PK, and PK/PD data.
• Serve as the toxicology expert on project teams and regulatory meetings.
• Prepare and review regulatory submission sections (pre-IND, IND/CTA, NDA/BLA).
• Lead business development activities and client interactions; travel up to 20%.
• Publish and present findings at scientific meetings and committees.

Skills

Scientific writing

Regulatory knowledge

Project management

Cross-functional collaboration

Independent work

Education

Ph.D. in toxicology or pharmacology

Job description

BlueRidge Life Sciences is seeking an experienced toxicologist with 15+ years in biopharmaceutical settings to join the ToxStrategies division. The role involves designing and overseeing nonclinical safety programs for drug candidates, interpreting safety data, and coordinating with regulatory agencies to support INDs, CTAs, and NDAs.

You will work with toxicologists, epidemiologists, engineers, and biostatisticians on multidisciplinary teams, contributing to study design, regulatory writing,