Senior Toxicology Consultant for Pharma

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

Job summary

BlueRidge Life Sciences is seeking an experienced toxicologist to join the ToxStrategies division, focusing on nonclinical safety assessment across drug development with regulatory strategy involvement.

The role involves overseeing study design, data interpretation, and collaboration with regulators and clients. A Ph.D. in toxicology or pharmacology and 15+ years of biopharmaceutical experience are preferred; travel up to 20% may be required.

Qualifications

• Ph.D. in toxicology, pharmacology, or related sciences; DABT certification desired but not required.
• Minimum 15+ years of pharmaceutical consulting and/or industry/government experience.
• Deep knowledge of ICH and regulatory guidance for nonclinical development.
• Experience leading nonclinical safety programs across all development phases.
• Experience writing regulatory documents and interacting with agencies like FDA.

Responsibilities

• Oversee study placement, design, data interpretation, and monitoring of toxicology studies.
• Serve as the toxicology representative on project teams.
• Write or oversee sections of regulatory submissions (pre-IND, IND/CTA, NDA/BLA).
• Attend regulatory meetings and publish or present data as needed.
• Travel up to ~20% is required.

Skills

Project management

Communication

Independent work

Professional organizations

Education

Ph.D. in toxicology

Job description

BlueRidge Life Sciences is seeking an experienced toxicologist to join the ToxStrategies division, focusing on nonclinical safety assessment across drug development with regulatory strategy involvement.

The role involves overseeing study design, data interpretation, and collaboration with regulators and clients. A Ph.D. in toxicology or pharmacology and 15+ years of biopharmaceutical experience are preferred; travel up to 20% may be required.