Senior Pharmaceutical Toxicology Consultant

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

Job summary

BlueRidge Life Sciences' ToxStrategies division seeks an experienced toxicologist (15+ years biopharmaceutical experience) to join our growing Pharmaceutical toxicology consulting practice. You will provide scientific, strategic, and regulatory guidance in nonclinical safety across drug development.

The role includes overseeing study design, data interpretation, writing regulatory sections, interacting with agencies, and contributing to business development.

Qualifications

• Ph.D. in toxicology, pharmacology, or related sciences; DABT optional.
• 15+ years pharma consulting/industry/government experience.
• Deep knowledge of ICH and regulatory guidance for nonclinical development.
• Experience leading nonclinical safety programs through all development phases.
• Experience writing regulatory documents and interacting with agencies.
• Strong written and verbal communication; independent or team work capability.
• Active involvement in scientific/toxicology professional organizations with recent activity.

Responsibilities

• Address scientific, regulatory, and business challenges in drug development.
• Oversee study design, data interpretation, and monitoring of toxicology studies; interpret PK/PD data.
• Serve as toxicology representative on project teams.
• Meet with global regulatory authorities.
• Write or oversee writing of regulatory sections (pre-IND, IND/CTA, NDA/BLA).
• Prepare expert opinions, waiver requests, presentations, proposals, etc.
• Participate in due diligence for in- and out-licensing.
• Present at toxicology meetings and publish work.
• Lead business development to attract new projects/clients.
• Travel may be required up to ~20%.

Skills

Toxicology

Pharmacology

Regulatory science

Nonclinical safety

ICH guidelines

Project management

Scientific writing

Team leadership

Regulatory interactions

Education

Ph.D. in toxicology

DABT desirable

Tools

Regulatory submissions

Job description

BlueRidge Life Sciences' ToxStrategies division seeks an experienced toxicologist (15+ years biopharmaceutical experience) to join our growing Pharmaceutical toxicology consulting practice. You will provide scientific, strategic, and regulatory guidance in nonclinical safety across drug development.

The role includes overseeing study design, data interpretation, writing regulatory sections, interacting with agencies, and contributing to business development.