Senior Pharmaceutical Toxicology Consultant

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

Job summary

BlueRidge Life Sciences’ ToxStrategies division seeks an experienced toxicologist with 15+ years in biopharmaceutical/pharmaceutical settings, including consulting and/or industry, government, or CROs, to lead nonclinical safety assessments and regulatory interactions.

The role involves designing and overseeing nonclinical safety programs, writing regulatory sections, and collaborating with cross-functional teams to advance drug development while engaging with regulatory authorities.

Qualifications

• Ph.D. in toxicology, pharmacology, or related sciences; DABT certification is desirable but not required.
• Minimum 15+ years of pharmaceutical consulting and/or pharmaceutical industry and/or government experience (e.g., FDA).
• Comprehensive understanding of ICH and regulatory guidance for nonclinical drug development.
• Experience overseeing nonclinical safety programs through all development phases (e.g., pre-IND to marketing).
• Experience writing regulatory documents (e.g., pre-IND packages, INDs, BLAs/NDAs) and interacting with regulators.

Responsibilities

• Address scientific, regulatory, and business challenges in pharmaceutical/biopharmaceutical development.
• Oversee study placement, design, data interpretation, and monitoring of toxicology studies.
• 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.

Skills

Project management

Regulatory knowledge

Scientific communication

Team leadership

Education

Ph.D. in toxicology or related field

Job description

BlueRidge Life Sciences’ ToxStrategies division seeks an experienced toxicologist with 15+ years in biopharmaceutical/pharmaceutical settings, including consulting and/or industry, government, or CROs, to lead nonclinical safety assessments and regulatory interactions.

The role involves designing and overseeing nonclinical safety programs, writing regulatory sections, and collaborating with cross-functional teams to advance drug development while engaging with regulatory authorities.