Senior Pharmaceutical Toxicology Consultant

BlueRidge Life Sciences; Salem (NH); On-site; USD 170,000 - 230,000; Full time

Job summary

BlueRidge Life Sciences’ ToxStrategies division seeks an experienced toxicologist with 15+ years in biopharmaceuticals to join our expanding pharmaceutical toxicology consulting practice.

You will design and oversee nonclinical safety programs, interpret PK/PD data, write regulatory sections, interact with agencies, and collaborate with leaders across epidemiology, engineering, and biostatistics in a multidisciplinary environment.

Qualifications

• Ph.D. in toxicology, pharmacology, or related sciences; DABT certification is desired but not required.
• Minimum 15+ years of pharmaceutical consulting and/or pharmaceutical industry and/or government experience (e.g., FDA).
• Deep understanding of ICH and regulatory guidance for nonclinical drug development.
• Experience overseeing nonclinical safety programs through all development phases.

Responsibilities

• Address scientific, regulatory, and business challenges in development of pharmaceutical/biopharmaceutical products.
• Oversee study placement, design, data interpretation, and monitoring of toxicology studies; interpret safety, TK/PK, and PK/PD data.
• Serve as toxicology representative on project teams and interact with regulatory authorities (e.g., FDA).
• Write or oversee writing of pharmacology/toxicology sections of regulatory submissions (pre-IND, IND/CTA, NDA/BLA).
• Travel may be required (up to ~20%).

Skills

Project management

Written communication

Verbal communication

Independent work

Team collaboration

Education

Ph.D. in toxicology

DABT certification

Job description

BlueRidge Life Sciences’ ToxStrategies division seeks an experienced toxicologist with 15+ years in biopharmaceuticals to join our expanding pharmaceutical toxicology consulting practice.

You will design and oversee nonclinical safety programs, interpret PK/PD data, write regulatory sections, interact with agencies, and collaborate with leaders across epidemiology, engineering, and biostatistics in a multidisciplinary environment.