Senior Pharmaceutical Toxicology Consultant

BlueRidge Life Sciences; New Jersey; Presencial; USD 180.000 - 240.000; Jornada completa

Descripción de la vacante

BlueRidge Life Sciences seeks an experienced toxicologist (15+ years) to join the ToxStrategies division in a senior consulting capacity. You will design and oversee nonclinical safety programs, interpret cross-study data, and contribute to regulatory submissions for biopharmaceutical products.

You will work with multidisciplinary teams, interact with global regulatory authorities, and help clients navigate ICH guidelines and development pathways from pre-IND to NDA/BLA, with opportunities for

Formación

• Ph.D. in toxicology or related sciences; DABT certification desired but not required.
• 15+ years of pharmaceutical/toxicology consulting or industry experience.

Responsabilidades

• Oversee nonclinical safety programs across all development phases.
• Interpret and integrate safety, TK/PK, and PK/PD data for regulatory submissions.
• Write nonclinical sections of regulatory documents (pre-IND, IND/CTA, NDA/BLA).
• Interact with regulatory agencies (FDA, EMA, MHRA).
• Travel up to 20% may be required.

Conocimientos

Nonclinical safety assessment

Regulatory strategy

Scientific writing

Project management

Communication

Educación

Ph.D. in toxicology

DABT certification desired

Descripción del empleo

BlueRidge Life Sciences seeks an experienced toxicologist (15+ years) to join the ToxStrategies division in a senior consulting capacity. You will design and oversee nonclinical safety programs, interpret cross-study data, and contribute to regulatory submissions for biopharmaceutical products.

You will work with multidisciplinary teams, interact with global regulatory authorities, and help clients navigate ICH guidelines and development pathways from pre-IND to NDA/BLA, with opportunities for