Senior Pharmaceutical Toxicology Consultant

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

Job summary

BlueRidge Life Sciences is seeking an experienced toxicologist to join the ToxStrategies division. The role requires deep biopharmaceutical toxicology expertise and a background in consulting or industry, with familiarity with regulatory submissions and global authorities.

You will design and oversee nonclinical safety programs, interpret multidisciplinary data, and contribute to client engagements across development stages from pre-IND to NDA/BLA. Travel may be required.

Qualifications

• Ph.D. degree in toxicology, pharmacology, or related sciences; DABT certification is desired but not required.
• 15+ years of pharmaceutical consulting and/or pharmaceutical industry and/or government experience (e.g., FDA) required.
• Comprehensive understanding of ICH and regulatory agency guidance documents for nonclinical drug development.
• Experience overseeing nonclinical safety assessment programs through all development phases (pre-IND to marketing).
• Experience writing regulatory documents (e.g., pre-IND packages, INDs, BLAs/NDAs) and interacting with regulatory agencies.
• Project management experience, including the ability to manage multiple assignments and stringent timelines.
• Demonstrated written and verbal communication skills.
• Ability to work independently or in multidisciplinary teams.
• Active involvement in scientific/toxicology professional organizations (e.g., BioSafe, SOT, ACT).

Responsibilities

• Address scientific, regulatory, and business challenges associated with development of pharmaceutical/biopharmaceutical products.
• 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.
• Participate in meetings with global regulatory authorities.
• Write or oversee writing of the pharmacology/toxicology sections of regulatory submission documents (e.g., pre-IND, IND/CTA, and NDA/BLA).
• Write or oversee writing of expert opinion reports, waiver requests, presentations, proposals, etc.
• Participate in due diligence meetings for in- and out-licensing.
• Attend and present at toxicology meetings (e.g., ACT, SOT), serve on committees, and publish.
• Conduct business development activities to attract and develop new projects/clients.
• Travel may be required (up to ~20%).

Skills

Written and verbal communication

Project management

Team collaboration

Regulatory knowledge

Education

Ph.D. in toxicology/pharmacology or related sciences

Job description

BlueRidge Life Sciences is seeking an experienced toxicologist to join the ToxStrategies division. The role requires deep biopharmaceutical toxicology expertise and a background in consulting or industry, with familiarity with regulatory submissions and global authorities.

You will design and oversee nonclinical safety programs, interpret multidisciplinary data, and contribute to client engagements across development stages from pre-IND to NDA/BLA. Travel may be required.