Senior Toxicology Consultant, Pharma & Regulatory

BlueRidge Life Sciences; Tallahassee (FL); On-site; USD 130,000 - 170,000; Full time

Job summary

BlueRidge Life Sciences, through its ToxStrategies division, seeks a senior toxicologist with 15+ years in biopharmaceuticals to lead nonclinical safety assessments and regulatory submissions.

The position involves designing studies, interpreting TK/PK data, and interfacing with global regulatory authorities. Travel up to 20% and leadership in a collaborative, multidisciplinary team are expected.

Qualifications

• Ph.D. in toxicology, pharmacology, or related sciences; DABT certification desired but not required.
• Minimum 15+ years of pharmaceutical consulting and/or pharmaceutical industry/government/CRO experience.
• Strong knowledge of ICH and regulatory guidance for nonclinical drug development.
• Experience overseeing nonclinical safety programs through all development phases.

Responsibilities

• Oversee study placement, design, data interpretation, and monitoring of toxicology studies.
• Write or oversee writing of pharmacology/toxicology sections of regulatory submissions.
• Interact with regulatory agencies (FDA, MHRA, EMA).
• Attend toxicology meetings and publish findings.
• Travel up to ~20% may be required.

Skills

Project management

Written communication

Verbal communication

Independent work

Team collaboration

Education

Ph.D. in toxicology/pharmacology or related sciences

DABT certification desired

Job description

BlueRidge Life Sciences, through its ToxStrategies division, seeks a senior toxicologist with 15+ years in biopharmaceuticals to lead nonclinical safety assessments and regulatory submissions.

The position involves designing studies, interpreting TK/PK data, and interfacing with global regulatory authorities. Travel up to 20% and leadership in a collaborative, multidisciplinary team are expected.