Senior Toxicology Strategy Lead

BlueRidge Life Sciences; North Carolina; On-site; USD 150,000 - 210,000; Full time

Job summary

BlueRidge Life Sciences is seeking an experienced toxicologist to join our ToxStrategies division in the United States. The ideal candidate will have 15+ years of biopharmaceutical/pharmaceutical experience, with consulting and/or industry, government (FDA) or CRO exposure.

You will lead nonclinical safety programs and interact with regulatory authorities. Responsibilities include designing safety studies, writing regulatory sections, and contributing to IND/CTA and NDA/BLA documents, while

Qualifications

• Ph.D. required in toxicology, pharmacology, or related sciences.
• DABT certification is desirable but not required.
• Minimum 15+ years of pharmaceutical consulting and/or pharmaceutical industry and/or government experience.
• Comprehensive understanding of ICH and regulatory guidance for nonclinical drug development.
• Experience writing regulatory documents and interacting with regulatory agencies.
• Experience leading complex toxicology programs and cross-functional teams.

Responsibilities

• Address scientific, regulatory, and business challenges in pharmaceutical/biopharmaceutical product development.
• Oversee study placement, design, data interpretation, and monitoring of toxicology studies; interpret safety data.
• Serve as the toxicology representative on project teams.
• Participate in meetings with global regulatory authorities.
• Write or oversee writing of pharmacology/toxicology sections of regulatory submissions (pre-IND, IND/CTA, NDA/BLA).
• Prepare expert opinions, waiver requests, proposals, and presentations.
• Participate in due diligence for in- and out-licensing deals.
• Attend toxicology meetings and contribute to committees; publish papers or book chapters.
• Contribute to business development to attract new projects and clients.
• Travel may be required (up to ~20%).

Skills

Communication

Project management

Independent work

Team collaboration

Education

Ph.D. in toxicology

DABT certification

Job description

BlueRidge Life Sciences is seeking an experienced toxicologist to join our ToxStrategies division in the United States. The ideal candidate will have 15+ years of biopharmaceutical/pharmaceutical experience, with consulting and/or industry, government (FDA) or CRO exposure.

You will lead nonclinical safety programs and interact with regulatory authorities. Responsibilities include designing safety studies, writing regulatory sections, and contributing to IND/CTA and NDA/BLA documents, while