Senior Toxicology Scientist — Pharma Consulting Leader

BlueRidge Life Sciences; Lorida (FL); On-site; USD 150,000 - 190,000; Full time

Job summary

BlueRidge Life Sciences’ ToxStrategies division seeks an experienced toxicologist with 15+ years of biopharmaceutical/pharmaceutical experience to join our expanding toxicology consulting practice. The role involves leading nonclinical safety programs, interpreting cross-study data, and authoring regulatory sections for submissions while collaborating with cross-functional teams.

Travel up to ~20% may be required. A Ph.D.

Qualifications

• Ph.D. in toxicology required; DABT certification desired but not required.
• Minimum 15+ years of pharmaceutical/biopharmaceutical experience in consulting and/or industry or government roles.
• Strong understanding of ICH and regulatory guidance for nonclinical drug development.
• Experience leading nonclinical safety programs and data integration across studies.
• Experience writing regulatory documents and interacting with regulatory agencies.

Responsibilities

• Oversee nonclinical safety assessment programs for drug candidates.
• Interpret safety, TK/PK, and PK/PD data across studies.
• Lead writing of pharmacology/toxicology sections of regulatory submissions.
• Interact with regulatory agencies and participate in due diligence meetings.
• Coordinate study protocols, reports, and expert opinion documents.

Skills

Regulatory knowledge

Project management

Scientific writing

Team leadership

Cross-functional collaboration

Education

Ph.D. in Toxicology

Job description

BlueRidge Life Sciences’ ToxStrategies division seeks an experienced toxicologist with 15+ years of biopharmaceutical/pharmaceutical experience to join our expanding toxicology consulting practice. The role involves leading nonclinical safety programs, interpreting cross-study data, and authoring regulatory sections for submissions while collaborating with cross-functional teams.

Travel up to ~20% may be required. A Ph.D.