Senior Toxicology Lead — Pharma Development Consulting

BlueRidge Life Sciences

Heber (UT)

On-site

USD 150,000 - 230,000

Full time

14 days+

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Benefits offered by this job

Competitive compensation and benefits

Job summary

BlueRidge Life Sciences’ ToxStrategies division seeks an experienced toxicologist (15+ years biopharmaceutical experience) to join our expanding pharmaceutical toxicology consulting practice. You will lead nonclinical safety programs, develop study strategies, and interpret safety data while interfacing with regulatory authorities.

This role includes contributing to regulatory submissions and mentoring junior staff.

Qualifications

Ph.D. in toxicology, pharmacology, or related sciences; DABT certification is desired but not required.
Prior pharmaceutical consulting and/or pharmaceutical industry and/or government experience (e.g., FDA) required (minimum 15+ years).
Comprehensive understanding of ICH and regulatory agency guidance documents for nonclinical drug development.
Experience overseeing nonclinical safety programs through all development phases.

Responsibilities

Address scientific, regulatory, and business challenges in development of pharmaceutical/biopharmaceutical products.
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 interact with regulatory authorities.
Write or oversee writing of regulatory submission sections (pre-IND, IND/CTA, NDA/BLA).
Participate in due diligence meetings for in- and out-licensing; travel when required (up to ~20%).