Senior Toxicology Strategy Lead

BlueRidge Life Sciences; Hartford (CT); On-site; USD 180,000 - 240,000; Full time

Job summary

BlueRidge Life Sciences is seeking an experienced toxicologist with 15+ years of biopharmaceutical/pharmaceutical expertise to join our ToxStrategies division. The role focuses on leading nonclinical safety programs, regulatory writing, and interactions with agencies such as FDA, EMA, and MHRA.

You will work with a multidisciplinary team of toxicologists, epidemiologists, engineers, and biostatisticians, shaping strategies across drug development and contributing to business growth and client

Qualifications

• Advanced toxicology knowledge and industry experience in pharma/biopharma consulting or industry
• Strong understanding of regulatory guidance documents for nonclinical drug development
• Proven ability to work with cross-functional teams and manage complex programs

Responsibilities

• Oversee nonclinical safety assessment programs across drug development phases
• Lead preparation of pharmacology/toxicology sections for regulatory submissions (pre-IND, IND/CTA, NDA/BLA)
• Interact with regulatory agencies and provide scientific/regulatory leadership on projects
• Guide study design, data interpretation, and risk assessments for toxicology programs
• Travel up to 20% as needed to support projects and clients

Skills

Toxicology leadership

Regulatory strategy

ICH guidelines

Communication skills

Education

PhD in Toxicology

DABT certification desired

Job description

BlueRidge Life Sciences is seeking an experienced toxicologist with 15+ years of biopharmaceutical/pharmaceutical expertise to join our ToxStrategies division. The role focuses on leading nonclinical safety programs, regulatory writing, and interactions with agencies such as FDA, EMA, and MHRA.

You will work with a multidisciplinary team of toxicologists, epidemiologists, engineers, and biostatisticians, shaping strategies across drug development and contributing to business growth and client