Senior Pharmaceutical Toxicologist - Consulting Expert

BlueRidge Life Sciences; Maryland; On-site; USD 180,000 - 240,000; Full time

Job summary

BlueRidge Life Sciences’ ToxStrategies division seeks an experienced toxicologist with 15+ years of biopharmaceutical/pharmaceutical experience to join our expanding toxicology consulting practice.

You will oversee nonclinical safety programs, interpret data across studies, and lead regulatory writing for submissions while collaborating with regulatory agencies and the project teams in a dynamic, leadership-driven environment.

Qualifications

• Ph.D. in toxicology or related science; DABT desired but not required.
• 15+ years of pharmaceutical consulting and/or industry/government experience.
• Strong knowledge of ICH and regulatory guidance for nonclinical development.
• Experience leading nonclinical safety programs across development phases.
• Excellent scientific writing and regulatory interactions with agencies.

Responsibilities

• Oversee nonclinical safety assessment programs for drug candidates.
• Interpret safety, TK/PK, and PK/PD data across studies.
• Lead writing of regulatory sections and expert reports.
• Interact with regulatory authorities (FDA, EMA, etc.).
• Manage project teams and multidisciplinary collaboration.
• Contribute to business development and client relationships.
• Travel up to ~20% may be required.

Skills

Toxicology expertise

Regulatory knowledge

Project management

Scientific writing

Communication skills

Team leadership

Education

PhD in toxicology/pharmacology or related sciences

DABT certification desired

Job description

BlueRidge Life Sciences’ ToxStrategies division seeks an experienced toxicologist with 15+ years of biopharmaceutical/pharmaceutical experience to join our expanding toxicology consulting practice.

You will oversee nonclinical safety programs, interpret data across studies, and lead regulatory writing for submissions while collaborating with regulatory agencies and the project teams in a dynamic, leadership-driven environment.