Senior Toxicology Consultant – Pharma & Regulatory

BlueRidge Life Sciences

Montgomery (AL)

On-site

USD 140,000 - 190,000

Full time

6 days ago

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Job summary

BlueRidge Life Sciences is seeking an experienced toxicologist to join the ToxStrategies division in its pharmaceutical toxicology consulting practice in the United States. The ideal candidate has 15+ years of biopharmaceutical/pharmaceutical experience in consulting and/or industry, government, or CROs, and a deep understanding of nonclinical safety assessment in drug development.

You will design and oversee nonclinical safety programs, integrate data across studies, interact with regulatory

Qualifications

Ph.D. in toxicology or pharmacology is required; DABT certification is desirable but not required.
Extensive pharmaceutical consulting/industry experience (15+ years) is required.
Experience with ICH/regulatory guidance for nonclinical drug development.

Responsibilities

Oversee nonclinical safety assessment programs across drug development stages.
Interpret safety, TK/PK, and PK/PD data; monitor studies and data quality.
Serve as toxicology representative on project teams; interact with regulatory authorities.
Write/regulate nonclinical sections of regulatory submissions (pre-IND, IND/CTA, NDA/BLA).
Lead business development efforts and participate in due diligence and client meetings.