Senior Pharmaceutical Toxicology Consultant

BlueRidge Life Sciences; Hydaburg (AK); On-site; USD 180,000 - 240,000; Full time

Job summary

BlueRidge Life Sciences is seeking an experienced toxicologist (15+ years biopharmaceutical/pharmaceutical experience) to join our expanding Pharmaceutical toxicology consulting practice.

The candidate will design and oversee nonclinical safety assessment programs, interact with regulatory authorities, and contribute to regulatory submissions while collaborating with a multidisciplinary team. Travel up to 20% may be required.

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 guidance for nonclinical drug development.
• Experience writing regulatory documents and interacting with regulatory agencies.

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 participate in regulatory meetings.
• Write or oversee writing of pharmacology/toxicology sections of regulatory submissions (pre-IND, IND/CTA, NDA/BLA).
• Travel may be required (up to ~20%).

Skills

Scientific writing

Project management

Regulatory understanding

Interdisciplinary collaboration

Education

Ph.D. in toxicology or related sciences

DABT certification desired

Job description

BlueRidge Life Sciences is seeking an experienced toxicologist (15+ years biopharmaceutical/pharmaceutical experience) to join our expanding Pharmaceutical toxicology consulting practice.

The candidate will design and oversee nonclinical safety assessment programs, interact with regulatory authorities, and contribute to regulatory submissions while collaborating with a multidisciplinary team. Travel up to 20% may be required.