Senior Toxicology Consultant — Pharma Regulatory Expert

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

Job summary

BlueRidge Life Sciences’ ToxStrategies division seeks a senior toxicologist with 15+ years of biopharmaceutical/pharmaceutical experience, in consulting and/or industry, government (FDA) or CROs. You will lead nonclinical safety programs, interact with regulators, and guide pharmacology/toxicology sections of regulatory submissions.

You will design and oversee study programs, interpret safety data, and mentor a multidisciplinary team of toxicologists, epidemiologists, engineers, and

Qualifications

• Ph.D. in toxicology, pharmacology, or related sciences; DABT certification is desired but not required.
• Comprehensive understanding of ICH and regulatory agency guidance for nonclinical drug development.
• Experience managing nonclinical safety assessment programs through all development phases.
• Strong written and verbal communication skills; ability to work independently or in multidisciplinary teams.

Responsibilities

• Address scientific, regulatory, and business challenges in pharmaceutical/biopharmaceutical development.
• Oversee study placement, data interpretation, and monitoring of toxicology studies; interpret TK/PK and PK/PD data.
• Serve as the toxicology representative on project teams.
• Participate in meetings with global regulatory authorities (FDA, MHRA, EMA).
• Write or oversee writing of pharmacology/toxicology sections of regulatory submissions (pre-IND, IND/CTA, NDA/BLA).
• Prepare expert opinions, waiver requests, and proposals.
• Engage in due diligence for in- and out-licensing activities.
• Present at toxicology meetings; contribute to professional committees and publications.
• Engage in business development to attract and develop new projects/clients.
• Travel may be required (up to ~20%).

Skills

Written communication

Verbal communication

Independent work

Team collaboration

Project management

Education

Ph.D. in toxicology/pharmacology/related sciences

DABT certification desired

Job description

BlueRidge Life Sciences’ ToxStrategies division seeks a senior toxicologist with 15+ years of biopharmaceutical/pharmaceutical experience, in consulting and/or industry, government (FDA) or CROs. You will lead nonclinical safety programs, interact with regulators, and guide pharmacology/toxicology sections of regulatory submissions.

You will design and oversee study programs, interpret safety data, and mentor a multidisciplinary team of toxicologists, epidemiologists, engineers, and