Senior Pharmaceutical Toxicology Consultant

BlueRidge Life Sciences; Guin (AL); On-site; USD 180,000 - 240,000; Full time

Job summary

BlueRidge Life Sciences' ToxStrategies division seeks an experienced toxicologist with 15+ years in biopharmaceuticals to join our consulting practice. You will design nonclinical safety programs, interpret data, and help prepare regulatory submissions.

Collaboration with epidemiologists, engineers, and biostatisticians is essential to delivering science-driven, compliant solutions. Ideal candidates hold a Ph.D.

Qualifications

• Ph.D. required with 15+ years of pharma consulting/industry/government experience
• Understanding of ICH and regulatory guidance for nonclinical development
• Experience writing regulatory documents (pre-IND/IND/CTA, BLA/NDA) and interacting with agencies
• Strong project management skills with ability to lead multiple studies and timelines
• Proven written and verbal communication skills; ability to work independently or within teams
• Member of scientific/toxicology professional organizations with recent activity/publications

Responsibilities

• Address scientific, regulatory, and business challenges in pharmaceutical/biopharmaceutical product development
• Oversee nonclinical safety program design and data interpretation across studies
• Serve as toxicology expert on project teams
• Interact with global regulatory authorities in meetings
• Prepare/write sections of regulatory submissions and expert opinions
• Lead due diligence for in- and out-licensing deals
• Attend and present at toxicology meetings; contribute to publications
• Support business development to attract new projects/clients
• Possible travel up to ~20%

Skills

Pharmaceutical consulting experience

Regulatory guidance familiarity

Written and verbal communication

Project management

Interdisciplinary collaboration

Independent/teamed work

Regulatory agency interaction

Education

Ph.D. in toxicology/pharmacology/related sciences

Job description

BlueRidge Life Sciences' ToxStrategies division seeks an experienced toxicologist with 15+ years in biopharmaceuticals to join our consulting practice. You will design nonclinical safety programs, interpret data, and help prepare regulatory submissions.

Collaboration with epidemiologists, engineers, and biostatisticians is essential to delivering science-driven, compliant solutions. Ideal candidates hold a Ph.D.