Senior Toxicology Scientist, Pharma Consulting

BlueRidge Life Sciences; Connecticut; On-site; USD 180,000 - 230,000; Full time

Job summary

BlueRidge Life Sciences seeks a senior toxicologist with 15+ years in biopharmaceuticals/pharmaceuticals, consulting or industry, government, or CROs. The role focuses on nonclinical safety assessment and regulatory strategy across development phases.

You will design/oversee nonclinical programs, write regulatory sections, and interact with agencies. A leading, collaborative team environment and competitive compensation are offered.

Qualifications

• Demonstrated written and verbal communication skills.
• Experience writing regulatory documents and interacting with regulatory agencies.
• Experience working with drug development teams through all development phases.
• Project management experience balancing multiple assignments and timelines.
• Active involvement in scientific/toxicology professional organizations.

Responsibilities

• Address scientific, regulatory, and business challenges in pharmaceutical/biopharmaceutical development.
• Oversee nonclinical safety programs, study placement, data interpretation, and PK/PD data.
• Serve as toxicology representative on project teams and regulatory meetings.
• Contribute to regulatory submissions (pre-IND, IND/CTA, NDA/BLA) and expert reports.
• Engage in due diligence meetings for in- and out-licensing and business development.

Skills

Communication skills

Project management

Regulatory writing

Team collaboration

Independent work

Scientific presentation

Education

Ph.D. in toxicology/pharmacology

DABT certification (desired)

Job description

BlueRidge Life Sciences seeks a senior toxicologist with 15+ years in biopharmaceuticals/pharmaceuticals, consulting or industry, government, or CROs. The role focuses on nonclinical safety assessment and regulatory strategy across development phases.

You will design/oversee nonclinical programs, write regulatory sections, and interact with agencies. A leading, collaborative team environment and competitive compensation are offered.