Senior Pharmaceutical Toxicology Consultant

BlueRidge Life Sciences; Manchester (NH); On-site; USD 180,000 - 280,000; Full time

Job summary

BlueRidge Life Sciences’ ToxStrategies division seeks an experienced toxicologist with 15+ years in biopharmaceuticals to lead nonclinical safety programs and regulatory strategy. You will interface with pharma teams, global regulators, and senior science staff, shaping safety assessments and regulatory submissions.

The role offers leadership opportunities, collaboration across disciplines, and a dynamic environment within a growing life sciences consulting practice.

Qualifications

• Ph.D. in toxicology, pharmacology, or related sciences.
• Minimum 15+ years of pharmaceutical consulting and/or industry experience.
• Comprehensive understanding of ICH and regulatory guidance for nonclinical development.
• Experience overseeing nonclinical safety programs through all development phases.
• Experience writing regulatory documents (e.g., pre-IND, INDs, BLAs/NDAs) and interacting with agencies.
• Project management experience and ability to manage multiple high-priority programs.
• Strong written and verbal communication skills; able to work independently or in teams.
• Active participation in scientific/toxicology organizations with recent publications.

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 the toxicology representative on project teams.
• Participate in meetings with global regulatory authorities.
• Write or oversee writing of pharmacology/toxicology sections of regulatory submissions (pre-IND, IND/CTA, NDA/BLA).
• Prepare expert opinions, waiver requests, presentations, proposals, etc.
• Participate in due diligence meetings for in- and out-licensing.
• Travel may be required (up to approximately 20%).

Education

Ph.D. in toxicology, pharmacology, or related sciences

DABT certification desired but not required

Job description

BlueRidge Life Sciences’ ToxStrategies division seeks an experienced toxicologist with 15+ years in biopharmaceuticals to lead nonclinical safety programs and regulatory strategy. You will interface with pharma teams, global regulators, and senior science staff, shaping safety assessments and regulatory submissions.

The role offers leadership opportunities, collaboration across disciplines, and a dynamic environment within a growing life sciences consulting practice.