Senior Pharmaceutical Toxicology Consultant

BlueRidge Life Sciences; Guin (AL); On-site; USD 190,000 - 270,000; Full time

Job summary

BlueRidge Life Sciences’s ToxStrategies division seeks an experienced toxicologist with 15+ years biopharmaceutical/pharmaceutical experience to join our expanding consulting practice.

The successful candidate will design and oversee nonclinical safety programs across all development stages, interact with regulatory agencies, and lead scientific teams while contributing to business development and client guidance.

Qualifications

• Ph.D. in toxicology or related science; DABT certification is desirable but not required.
• 15+ years of pharmaceutical consulting and/or pharmaceutical industry and/or government experience (e.g., FDA).
• In-depth knowledge of ICH and regulatory guidance for nonclinical drug development.
• Experience supervising nonclinical safety programs across all development phases (pre-IND to marketing).
• Experience writing regulatory documents (pre-IND packages, INDs, BLAs/NDAs) and interacting with agencies.
• Strong project management and the ability to balance multiple high-priority programs and timelines.
• Excellent written and verbal communication skills; ability to work independently or in multidisciplinary teams.
• Active involvement in scientific/toxicology organizations with recent presentations/publications.

Responsibilities

• Address scientific, regulatory, and business challenges in pharmaceutical/biopharmaceutical development.
• Oversee study placement, design, data interpretation, and monitoring of toxicology studies; interpret safety and PK/PD data.
• Serve as toxicology representative on project teams and participate in meetings with global regulators.
• Prepare and review pharmacology/toxicology content for regulatory submissions (pre-IND, IND/CTA, NDA/BLA).
• Lead technical writing of expert opinions, waiver requests, and proposals; support due diligence.
• Engage in business development activities to attract new projects and clients; travel up to ~20%.

Skills

Project management

Communication skills

Independent work

Team collaboration

Regulatory knowledge

Leadership

Strategic thinking

Education

Ph.D. in toxicology

DABT certification (desirable)

Job description

BlueRidge Life Sciences’s ToxStrategies division seeks an experienced toxicologist with 15+ years biopharmaceutical/pharmaceutical experience to join our expanding consulting practice.

The successful candidate will design and oversee nonclinical safety programs across all development stages, interact with regulatory agencies, and lead scientific teams while contributing to business development and client guidance.