Senior Pharmaceutical Toxicologist & Regulatory Strategist

BlueRidge Life Sciences; Alaska; In loco; USD 180.000 - 240.000; Tempo pieno

Descrizione del lavoro

BlueRidge Life Sciences' ToxStrategies division seeks an experienced toxicologist with 15+ years in biopharmaceuticals to lead nonclinical safety programs and guide regulatory strategy.

The role involves designing study programs, interpreting safety and PK/PD data, and coordinating with agencies. You will collaborate with toxicologists, epidemiologists, engineers, and biostatisticians, with growth and leadership opportunities, competitive compensation, and benefits.

Competenze

• Ph.D. degree in toxicology, pharmacology, or related sciences.
• Minimum 15+ years pharmaceutical consulting/industry/government/CRO experience.
• Solid knowledge of ICH and regulatory guidance for nonclinical development.

Mansioni

• Address scientific, regulatory, and business challenges in pharmaceutical development.
• Oversee nonclinical safety programs across development phases.
• Prepare and review regulatory sections and interact with agencies (FDA, EMA, MHRA).
• Lead study design, data interpretation, and project team coordination.
• Travel up to ~20% may be required.

Conoscenze

Excellent written and verbal comms

Project management

Independent and team work

Formazione

Ph.D. in toxicology/pharmacology

DABT certification desired

Descrizione del lavoro

BlueRidge Life Sciences' ToxStrategies division seeks an experienced toxicologist with 15+ years in biopharmaceuticals to lead nonclinical safety programs and guide regulatory strategy.

The role involves designing study programs, interpreting safety and PK/PD data, and coordinating with agencies. You will collaborate with toxicologists, epidemiologists, engineers, and biostatisticians, with growth and leadership opportunities, competitive compensation, and benefits.