Senior Pharmaceutical Toxicology Consultant (15+ yrs)

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

Job summary

BlueRidge Life Sciences is seeking an experienced toxicologist (15+ years in biopharmaceuticals) to join the ToxStrategies division. You will lead nonclinical safety programs, interact with regulatory authorities, and contribute to strategic regulatory submissions across development stages.

The role offers a challenging consulting environment with opportunities for leadership and professional development within a multidisciplinary team of toxicologists, epidemiologists, engineers, and

Qualifications

• Ph.D. in toxicology, pharmacology, or related sciences; DABT certification is desired but not required.
• 15+ years of pharma consulting/industry/government experience (e.g., FDA).
• Comprehensive understanding of ICH and regulatory guidance for nonclinical drug development.
• Experience leading nonclinical safety programs through all development phases.
• Experience writing regulatory documents (pre-IND packages, INDs, BLAs/NDAs) and interacting with agencies.

Responsibilities

• Address scientific, regulatory, and business challenges in pharmaceutical/biopharmaceutical product development.
• Oversee study placement, design, data interpretation, and monitoring of toxicology studies; interpret safety data.
• Serve as toxicology representative on project teams; participate in meetings with regulatory authorities.
• 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

Written and verbal communication

Independent work

Multidisciplinary teamwork

Project management

Education

Ph.D. in toxicology/pharmacology

DABT certification (desired)

Job description

BlueRidge Life Sciences is seeking an experienced toxicologist (15+ years in biopharmaceuticals) to join the ToxStrategies division. You will lead nonclinical safety programs, interact with regulatory authorities, and contribute to strategic regulatory submissions across development stages.

The role offers a challenging consulting environment with opportunities for leadership and professional development within a multidisciplinary team of toxicologists, epidemiologists, engineers, and