Senior Toxicology Consultant & Program Leader

BlueRidge Life Sciences; Clayton (NC); On-site; USD 180,000 - 260,000; Full time

Job summary

BlueRidge Life Sciences, ToxStrategies division, seeks an experienced toxicologist with 15+ years in biopharmaceuticals to lead nonclinical safety programs and support regulatory submissions. You will collaborate with toxicologists, epidemiologists, engineers, and biostatisticians on challenging projects in drug development.

Responsibilities include study oversight, data interpretation, authoring regulatory sections, and interaction with agencies such as FDA or EMA.

Qualifications

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

Responsibilities

• Address scientific, regulatory, and business challenges in pharmaceutical development.
• Oversee toxicology study placement, design, data interpretation, and PK/PD data.
• Serve as toxicology representative on project teams and with regulatory bodies.
• Draft or supervise pharmacology/toxicology sections of regulatory submissions.
• Lead due diligence for in- and out-licensing activities.
• Travel up to 20% may be required.

Skills

Toxicology

Pharmacology

Regulatory knowledge

Project management

Scientific writing

Education

Ph.D. in toxicology or related sciences

DABT certification desired

Job description

BlueRidge Life Sciences, ToxStrategies division, seeks an experienced toxicologist with 15+ years in biopharmaceuticals to lead nonclinical safety programs and support regulatory submissions. You will collaborate with toxicologists, epidemiologists, engineers, and biostatisticians on challenging projects in drug development.

Responsibilities include study oversight, data interpretation, authoring regulatory sections, and interaction with agencies such as FDA or EMA.