Senior Toxicology Leader — Pharma Consulting

BlueRidge Life Sciences

Beryl (WV)

On-site

USD 150,000 - 230,000

Full time

11 days ago

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Job summary

BlueRidge Life Sciences, a leading life sciences services firm, seeks a senior toxicologist to lead nonclinical safety strategies for biopharmaceutical programs. The role offers collaboration with epidemiologists, engineers, and biostatisticians, and focuses on regulatory submissions, scientific leadership, and strategic oversight across development stages.

The candidate will oversee study design, data interpretation, and regulatory interactions, contributing to pre-IND, IND/CTA, and NDA/BLA

Qualifications

Ph.D. in toxicology, pharmacology, or related sciences.
Minimum 15+ years in pharmaceutical consulting/industry/government.
Deep knowledge of ICH and regulatory guidance for nonclinical development.
Experience leading nonclinical safety programs across all development phases.
Experience writing regulatory documents and interacting with agencies.

Responsibilities

Oversee nonclinical safety programs across drug development.
Interpret safety, TK/PK, and PK/PD data for toxicology studies.
Serve as toxicology lead on project teams and liaise with stakeholders.
Prepare/writing of regulatory sections for submissions (pre-IND, IND/CTA, NDA/BLA).
Engage with regulatory agencies (FDA/EMA/MHRA) as needed.
Contribute to due diligence and business development activities.
Travel may be required (up to ~20%).