Senior Pharmaceutical Toxicology Consultant

BlueRidge Life Sciences; Atlanta (GA); In loco; USD 180.000 - 250.000; Tempo pieno

Descrizione del lavoro

BlueRidge Life Sciences is seeking an experienced toxicologist (15+ years) to join the ToxStrategies division and lead nonclinical safety programs across drug development. You will work with a multidisciplinary team of toxicologists, epidemiologists, engineers, and biostatisticians to deliver science-driven solutions to clients ranging from biotech startups to large pharma.

The role offers opportunities for leadership, collaboration with regulatory agencies, and exposure to diverse therapeutic

Competenze

• Ph.D. in toxicology, pharmacology, or related sciences; DABT certification is desired but not required.
• Minimum 15+ years of pharma consulting, industry, or government experience (FDA).
• Comprehensive understanding of ICH and regulatory guidance for nonclinical drug development.
• Experience overseeing nonclinical safety programs through all development phases.
• Experience writing regulatory documents (e.g., pre-IND packages, INDs, BLAs/NDAs) and interacting with agencies.
• Project management and ability to balance complex, high-priority programs and timelines.

Mansioni

• 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.
• Write or oversee writing of expert opinions, waiver requests, proposals, etc.
• Attend and present at toxicology meetings; publish papers or chapters when possible.
• Conduct business development activities to attract new projects/clients.
• Travel may be required (up to ~20%).

Conoscenze

Project management

Regulatory communication

Independent work

Scientific leadership

Formazione

Ph.D. in toxicology/pharmacology

DABT certification desirable

Descrizione del lavoro

BlueRidge Life Sciences is seeking an experienced toxicologist (15+ years) to join the ToxStrategies division and lead nonclinical safety programs across drug development. You will work with a multidisciplinary team of toxicologists, epidemiologists, engineers, and biostatisticians to deliver science-driven solutions to clients ranging from biotech startups to large pharma.

The role offers opportunities for leadership, collaboration with regulatory agencies, and exposure to diverse therapeutic