Senior Toxicology Strategist for Pharma Consulting

BlueRidge Life Sciences; Provo (UT); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Competitive compensation and benefits

Job summary

BlueRidge Life Sciences is seeking an experienced toxicologist to join our Pharmaceutical toxicology consulting practice within ToxStrategies. The candidate will design and oversee nonclinical safety programs across all development phases and interact with regulatory agencies (FDA, EMA).

Ideal candidates have a Ph.D. in toxicology or pharmacology, 15+ years in pharma/consulting, and experience with IND/CTA submissions, GLP studies, and risk assessment. Travel up to 20% may be required.

Qualifications

• Ph.D. in toxicology, pharmacology, or related sciences.
• DABT certification is desired but not required.
• Minimum 15+ years in pharmaceutical consulting and/or industry/government/CROs.
• Deep understanding of ICH and regulatory guidance for nonclinical development.
• Experience writing regulatory documents (pre-IND, IND/CTA, NDA/BLA).

Responsibilities

• Address scientific, regulatory, and business challenges in pharma/biopharma development.
• Oversee study placement, design, data interpretation, and monitoring of toxicology studies.
• Serve as the toxicology representative on project teams.
• Prepare and review pharmacology/toxicology sections of regulatory submissions.
• Lead due diligence meetings for in- and out-licensing.
• Attend scientific meetings and contribute to publications.
• Engage in business development to attract new projects.
• Travel up to ~20%.

Skills

Toxicology

Pharmacology

Regulatory guidance

Project management

Written communication

Verbal communication

Education

Ph.D. in toxicology or pharmacology

DABT certification (desirable)

Job description

BlueRidge Life Sciences is seeking an experienced toxicologist to join our Pharmaceutical toxicology consulting practice within ToxStrategies. The candidate will design and oversee nonclinical safety programs across all development phases and interact with regulatory agencies (FDA, EMA).

Ideal candidates have a Ph.D. in toxicology or pharmacology, 15+ years in pharma/consulting, and experience with IND/CTA submissions, GLP studies, and risk assessment. Travel up to 20% may be required.