Senior Pharmaceutical Toxicology Consultant

BlueRidge Life Sciences; Alabama; Presencial; USD 180.000 - 240.000; Jornada completa

Descripción de la vacante

BlueRidge Life Sciences seeks an experienced toxicologist (15+ years in biopharmaceutical/pharmaceutical settings) to join the ToxStrategies division. The role focuses on nonclinical safety assessment, regulatory strategy, and interactions with agencies such as FDA and MHRA.

You will design study programs, oversee data interpretation, and contribute to regulatory documents while collaborating with epidemiologists, engineers, and biostatisticians in a challenging, growth-oriented environment.

Formación

• Ph.D. degree in toxicology, pharmacology, or related sciences; DABT certification is desired but not required.
• Minimum 15+ years of pharmaceutical consulting, industry, government, or CRO experience.
• Comprehensive understanding of ICH and regulatory guidance for nonclinical drug development.
• Experience overseeing nonclinical safety programs through all development phases.
• Experience writing regulatory documents (pre-IND, INDs, BLAs/NDAs) and interacting with authorities.
• Strong written and verbal communication; able to work independently or in multidisciplinary teams.

Responsabilidades

• Oversee nonclinical safety assessment programs for drug candidates.
• Design, oversee, and interpret toxicology studies and monitor TK/PK data.
• Serve as the toxicology representative on project teams.
• Participate in meetings with global regulatory authorities.
• Write or oversee nonclinical sections of regulatory submissions (pre-IND, IND/CTA, NDA/BLA).
• Prepare expert opinions, waiver requests, and proposals.
• Participate in due diligence for in- and out-licensing.
• Attend toxicology meetings and contribute to publications.
• Travel may be required (up to ~20%).

Conocimientos

Regulatory guidance knowledge

Project management experience

Scientific communication

Independent work / team collaboration

Regulatory agency interaction

Educación

Ph.D. in toxicology or related sciences

DABT certification desirable

Descripción del empleo

BlueRidge Life Sciences seeks an experienced toxicologist (15+ years in biopharmaceutical/pharmaceutical settings) to join the ToxStrategies division. The role focuses on nonclinical safety assessment, regulatory strategy, and interactions with agencies such as FDA and MHRA.

You will design study programs, oversee data interpretation, and contribute to regulatory documents while collaborating with epidemiologists, engineers, and biostatisticians in a challenging, growth-oriented environment.