Senior Toxicology Consultant — Pharma & Regulatory Strategy

BlueRidge Life Sciences

New York (NY)

On-site

USD 180,000 - 280,000

Full time

6 days ago

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Job summary

BlueRidge Life Sciences' ToxStrategies division seeks an experienced toxicologist (15+ years) to lead nonclinical safety programs across all drug development phases. You will design studies, interpret complex toxicology data, and interact with regulatory agencies such as FDA.

The role combines scientific leadership with regulatory strategy and business development in a dynamic consulting environment. The position offers opportunities for professional growth, collaboration with top scientists,

Qualifications

Ph.D. in toxicology, pharmacology, or related sciences; DABT certification is desired but not required.
Minimum 15+ years of pharmaceutical consulting and/or pharmaceutical industry and/or government experience (e.g., FDA).
Comprehensive understanding of ICH and regulatory agency guidance for nonclinical development.
Experience overseeing nonclinical safety programs through all development phases (pre-IND to marketing).
Experience writing regulatory documents (pre-IND, IND/CTA, BLAs/NDAs) and interacting with regulators.

Responsibilities

Oversee study placement, design, data interpretation, and monitoring of toxicology studies and interpret safety, TK/PK, and PK/PD data.
Serve as the toxicology representative on project teams and participate in regulatory meetings.
Write or oversee writing of pharmacology/toxicology sections of regulatory submissions (pre-IND/IND/CTA/NDA&BLA).
Lead business development activities to attract and develop new projects/clients.
Travel may be required up to ~20%.