Senior Toxicology Consultant - Pharma & Regulatory

BlueRidge Life Sciences; East Windsor Hill (CT); On-site; USD 150,000 - 230,000; Full time

Job summary

BlueRidge Life Sciences's ToxStrategies division seeks an experienced toxicologist with 15+ years in biopharmaceutical/pharmaceutical settings, consulting or industry, government, or CROs, to lead nonclinical safety consulting.

The role involves designing and overseeing nonclinical safety programs, interpreting safety data, writing regulatory sections, and interacting with agencies such as FDA. Travel up to ~20% may be required.

Qualifications

• Ph.D. degree in toxicology, pharmacology, or related sciences; DABT certification is desired but not required.
• 15+ years of pharmaceutical consulting/industry/government experience.
• Comprehensive understanding of ICH and regulatory guidance documents for nonclinical drug development.
• Experience leading nonclinical safety programs through all development phases (pre-IND to marketing).
• Experience writing regulatory documents (pre-IND packages, INDs, BLAs/NDAs) and interacting with regulatory agencies.
• Project management experience and ability to manage multiple high-priority programs.
• Demonstrated written and verbal communication skills; able to work independently or in multidisciplinary teams.
• Active involvement in scientific/toxicology professional organizations.

Responsibilities

• Address scientific, regulatory, and business challenges in pharma/biopharma product development.
• Oversee study placement, design, data interpretation, and monitoring of toxicology studies; interpret TK/PK data.
• Serve as the toxicology representative on project teams and participate in regulatory meetings.
• Write or oversee writing of pharmacology/toxicology sections of regulatory submissions (pre-IND, IND/CTA, NDA/BLA).
• Write or oversee expert opinion reports, waiver requests, proposals, etc.
• Participate in due diligence for in- and out-licensing; travel may be required up to ~20%.
• Attend and present at toxicology meetings and engage in professional committees.

Skills

Toxicology

Pharmacology

Regulatory experience

Project management

Written communication

Independent worker

Education

Ph.D. in toxicology

DABT certification (desired)

Job description

BlueRidge Life Sciences's ToxStrategies division seeks an experienced toxicologist with 15+ years in biopharmaceutical/pharmaceutical settings, consulting or industry, government, or CROs, to lead nonclinical safety consulting.

The role involves designing and overseeing nonclinical safety programs, interpreting safety data, writing regulatory sections, and interacting with agencies such as FDA. Travel up to ~20% may be required.