Senior Pharmaceutical Toxicology Consultant

BlueRidge Life Sciences; New Hampshire; 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.

This role involves designing nonclinical safety programs, interpreting data across studies, and writing regulatory sections for pre-IND, IND/CTA, and NDA/BLA submissions, collaborating with experts across disciplines to deliver science-driven solutions.

Qualifications

• Ph.D. in toxicology, pharmacology, or related sciences; 15+ years of pharmaceutical consulting/industry/government experience required.
• Comprehensive understanding of ICH and regulatory guidance documents for nonclinical drug development.
• Experience writing regulatory documents (pre-IND packages, INDs, BLAs/NDAs) and interacting with regulators.

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 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 opinion reports, waiver requests, presentations, proposals; support due diligence for in- and out-licensing.
• Attend toxicology meetings (ACT, SOT); publish papers or book chapters; contribute to scientific committees.
• Engage in business development to attract and develop new projects/clients.
• Travel may be required (up to ~20%).

Skills

Toxicology expertise

Regulatory knowledge

Pharmaceutical consulting experience

Scientific writing

Project management

Communication skills

Education

Ph.D. in toxicology/pharmacology or related sciences

DABT certification desired but not required

Job description

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

This role involves designing nonclinical safety programs, interpreting data across studies, and writing regulatory sections for pre-IND, IND/CTA, and NDA/BLA submissions, collaborating with experts across disciplines to deliver science-driven solutions.