Senior Toxicology Consultant – Pharma & Regulatory

BlueRidge Life Sciences; Atlanta (GA); On-site; USD 210,000 - 270,000; Full time

Job summary

The ToxStrategies division of BlueRidge Life Sciences is seeking an experienced toxicologist with 15+ years of biopharmaceutical/pharmaceutical experience in consulting, industry, government, or CROs to join our expanding Pharmaceutical toxicology practice.

The candidate will oversee nonclinical safety programs, interpret safety and PK/PD data, and interact with regulatory authorities to support regulatory submissions.

Qualifications

• Ph.D. in toxicology, pharmacology, or related sciences; DABT certification is desired but not required.
• 15+ years of pharmaceutical consulting and/or industry/government/CRO experience.
• Strong knowledge of ICH and regulatory guidance for nonclinical drug development.
• Experience leading nonclinical safety programs through all development stages.
• Experience writing regulatory documents and interacting with agencies.

Responsibilities

• Oversee nonclinical safety assessment programs and study design.
• Interpret safety, TK/PK, and PK/PD data for decision making.
• Represent toxicology on project teams and coordinate with regulators.
• Prepare and review regulatory submission components (pre-IND, IND/CTA, NDA/BLA).
• Lead and participate in due diligence and business development activities.
• Attend and present at industry meetings; publish and contribute to science.

Skills

PhD in toxicology

DABT certification (desired)

Pharmaceutical consulting

Regulatory guidance

Nonclinical safety

Project management

Cross-functional collaboration

Education

Ph.D. in toxicology or related field

Job description

The ToxStrategies division of BlueRidge Life Sciences is seeking an experienced toxicologist with 15+ years of biopharmaceutical/pharmaceutical experience in consulting, industry, government, or CROs to join our expanding Pharmaceutical toxicology practice.

The candidate will oversee nonclinical safety programs, interpret safety and PK/PD data, and interact with regulatory authorities to support regulatory submissions.