Senior Toxicology Lead, Pharma Safety & Strategy

BlueRidge Life Sciences; Charlotte (NC); On-site; USD 180,000 - 210,000; Full time

Job summary

BlueRidge Life Sciences' ToxStrategies division seeks an experienced toxicologist (15+ years in biopharmaceutical/pharmaceutical settings) to expand our pharmaceutical toxicology consulting practice in North Carolina. You will guide nonclinical safety programs, interact with regulators, and lead study design and data interpretation.

Join a multidisciplinary team of toxicologists, epidemiologists, engineers, and biostatisticians, with opportunities for leadership, professional development, and

Qualifications

• PhD in toxicology, pharmacology, or related sciences.
• 15+ years pharmaceutical consulting/industry/government experience.
• Comprehensive understanding of ICH and regulatory guidance.
• Experience overseeing nonclinical safety programs through all development phases.
• Experience writing regulatory documents and interacting with agencies.
• Project management experience balancing multiple high-priority programs.
• Strong written and verbal communication skills.
• Ability to work independently or in multidisciplinary teams.
• Active involvement in scientific/toxicology professional organizations.

Responsibilities

• Address scientific, regulatory, and business challenges in drug development.
• Oversee study placement, design, data interpretation, and monitoring of toxicology studies.
• Serve as the toxicology representative on project teams.
• Participate in meetings with global regulatory authorities.
• Write or oversee writing of regulatory submission sections.
• Write or oversee writing of expert opinions, waivers, proposals, and reports.
• Participate in due diligence meetings for licensing opportunities.
• Attend toxicology meetings, contribute to publications, and present findings.
• Travel may be required (up to ~20%).

Skills

PhD in Toxicology

DABT certification

Pharmaceutical consulting experience

Regulatory knowledge (ICH)

Nonclinical safety oversight

Regulatory writing

Communication skills

Team collaboration

Industry/government exposure

Education

PhD in toxicology, pharmacology, or related sciences

Job description

BlueRidge Life Sciences' ToxStrategies division seeks an experienced toxicologist (15+ years in biopharmaceutical/pharmaceutical settings) to expand our pharmaceutical toxicology consulting practice in North Carolina. You will guide nonclinical safety programs, interact with regulators, and lead study design and data interpretation.

Join a multidisciplinary team of toxicologists, epidemiologists, engineers, and biostatisticians, with opportunities for leadership, professional development, and