Senior Pharmaceutical Toxicology Leader

BlueRidge Life Sciences; New Hampshire; On-site; USD 180,000 - 250,000; Full time

Job summary

BlueRidge Life Sciences is seeking an experienced toxicologist with 15+ years in biopharmaceuticals or pharmaceuticals, to join our expanding Pharmaceutical toxicology consulting practice within the ToxStrategies division.

The candidate will design and oversee nonclinical safety programs, interpret TK/PK/PD data, and contribute to regulatory submissions while collaborating with scientists across regulatory affairs, engineering, and clinical teams.

Qualifications

• Ph.D. in toxicology, pharmacology, or a related sciences field.
• 15+ years of pharma consulting/industry/government experience.
• Comprehensive understanding of ICH and regulatory guidance documents for nonclinical drug development.
• Experience leading nonclinical safety programs across all development stages.
• Experience writing regulatory documents (pre-IND, INDs, BLAs/NDAs) and engaging with regulatory agencies.
• Strong project management and the ability to balance multiple priorities in a fast-paced environment.
• Active involvement in scientific/toxicology professional organizations with recent work.

Responsibilities

• Oversee design, placement, data interpretation, and monitoring of toxicology studies.
• Serve as the toxicology lead on project teams and regulatory interactions.
• Write or oversee pharmacology/toxicology sections of regulatory submissions.
• Participate in due diligence meetings for in- and out-licensing.
• Attend toxicology meetings and contribute to publications or conference presentations.
• Travel may be required (up to ~20%).

Skills

Project management

Written communication

Regulatory strategy

Education

Ph.D. in toxicology/pharmacology or related sciences

DABT certification desired

Job description

BlueRidge Life Sciences is seeking an experienced toxicologist with 15+ years in biopharmaceuticals or pharmaceuticals, to join our expanding Pharmaceutical toxicology consulting practice within the ToxStrategies division.

The candidate will design and oversee nonclinical safety programs, interpret TK/PK/PD data, and contribute to regulatory submissions while collaborating with scientists across regulatory affairs, engineering, and clinical teams.