Senior Pharmaceutical Toxicology Consultant

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

Resumo da vaga

BlueRidge Life Sciences is seeking an experienced toxicologist with 15+ years in biopharmaceuticals or consulting to join our Pharmaceutical toxicology practice. The role focuses on nonclinical safety assessment, regulatory strategy, and cross-functional collaboration with drug development teams.

Strong candidate will oversee study design, data interpretation, and regulatory submissions. The position offers opportunities for leadership, professional development, and engagement with global

Qualificações

• Ph.D. degree 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 writing regulatory documents (pre-IND, IND/CTA, BLAs/NDAs) and interacting with regulatory agencies.
• Project management experience with the ability to manage multiple assignments and strict timelines.
• Strong written and verbal communication skills; ability to work independently or in multidisciplinary teams.

Responsabilidades

• Address scientific, regulatory, and business challenges in pharmaceutical/biopharmaceutical development.
• Oversee study design, data interpretation, and monitoring of toxicology studies; interpret TK/PK and PK/PD data.
• Represent toxicology on project teams and participate in regulatory meetings with agencies (FDA, MHRA, EMA).
• Write or oversee pharmacology/toxicology sections of regulatory submissions (pre-IND, IND/CTA, NDA/BLA).
• Contribute to due diligence for in-licensing and business development; travel up to 20% may be required.

Formação

Ph.D. in toxicology/pharmacology/related sciences

Descrição da vaga

BlueRidge Life Sciences is seeking an experienced toxicologist with 15+ years in biopharmaceuticals or consulting to join our Pharmaceutical toxicology practice. The role focuses on nonclinical safety assessment, regulatory strategy, and cross-functional collaboration with drug development teams.

Strong candidate will oversee study design, data interpretation, and regulatory submissions. The position offers opportunities for leadership, professional development, and engagement with global