Senior Toxicology Consultant – Pharma Development

BlueRidge Life Sciences; Georgia; Presencial; USD 180.000 - 240.000; Tempo integral

Resumo da vaga

BlueRidge Life Sciences is seeking an experienced toxicologist to join our expanding Pharmaceutical toxicology consulting practice. The role requires senior expertise in nonclinical safety, regulatory strategy, and cross‑functional collaboration across development teams.

You will oversee nonclinical safety programs, contribute to regulatory submissions, and interact with authorities such as the FDA. This position offers growth opportunities, leadership exposure, and a competitive package in a

Qualificações

• 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 development.
• Experience leading nonclinical safety programs and interacting with regulatory agencies.

Responsabilidades

• Address scientific, regulatory, and business challenges in pharmaceutical/biopharmaceutical development.
• Oversee study placement, design, data interpretation, and monitoring of toxicology studies; interpret safety and PK/PD data.
• Serve as 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).
• Write or oversee expert opinions, waiver requests, presentations, proposals, etc.
• Participate in due diligence meetings for in- and out-licensing; travel up to ~20%.

Conhecimentos

Regulatory interaction

Project management

Scientific communication

Team collaboration

Formação

Ph.D. in toxicology/pharmacology/related sciences

DABT certification desirable

Descrição da vaga

BlueRidge Life Sciences is seeking an experienced toxicologist to join our expanding Pharmaceutical toxicology consulting practice. The role requires senior expertise in nonclinical safety, regulatory strategy, and cross‑functional collaboration across development teams.

You will oversee nonclinical safety programs, contribute to regulatory submissions, and interact with authorities such as the FDA. This position offers growth opportunities, leadership exposure, and a competitive package in a