Senior Pharmaceutical Toxicology Consultant

BlueRidge Life Sciences; Pennsylvania; On-site; USD 180,000 - 260,000; Full time

Job summary

BlueRidge Life Sciences’ ToxStrategies division seeks an experienced toxicologist with 15+ years in biopharmaceutical/pharmaceutical settings, including consulting or industry. You will guide nonclinical safety assessments, interact with regulatory agencies, and lead cross-functional teams on drug development programs.

The role emphasizes design and oversight of toxicology studies, regulatory submissions, and collaboration with epidemiologists, engineers, and biostatisticians.

Qualifications

• Ph.D. in toxicology, pharmacology, or related sciences, required or equivalent experience.
• Experience with nonclinical safety assessment across development stages.
• Strong understanding of ICH and regulatory guidelines for drug development.
• Excellent written and verbal communication; ability to lead and collaborate.

Responsibilities

• Oversee nonclinical safety programs for drug candidates across development phases.
• Interpret and integrate safety, TK/PK, and PK/PD data for clients and regulators.
• Prepare regulatory documentation sections (pre-IND, IND/CTA, NDA/BLA) and briefs.
• Lead study design, data interpretation, and cross-functional team coordination.
• Travel up to 20% may be required.

Skills

Toxicology

Pharmacology

Regulatory guidance

Nonclinical safety

Project management

Scientific communication

Team collaboration

Independent work

Education

Ph.D. in toxicology/pharmacology/related sciences

DABT certification (desired)

Job description

BlueRidge Life Sciences’ ToxStrategies division seeks an experienced toxicologist with 15+ years in biopharmaceutical/pharmaceutical settings, including consulting or industry. You will guide nonclinical safety assessments, interact with regulatory agencies, and lead cross-functional teams on drug development programs.

The role emphasizes design and oversight of toxicology studies, regulatory submissions, and collaboration with epidemiologists, engineers, and biostatisticians.