Senior Pharmaceutical Toxicology Strategist

BlueRidge Life Sciences; Alabama; On-site; USD 170,000 - 250,000; Full time

Job summary

BlueRidge Life Sciences is seeking an experienced toxicologist (15+ years biopharmaceutical/pharmaceutical experience) to join our expanding Pharmaceutical toxicology consulting practice. This role involves designing nonclinical safety programs and collaborating across teams.

You will interact with regulatory authorities, write regulatory sections, and lead studies from pre-IND to NDA, with opportunities for professional development and leadership in a dynamic, multidisciplinary environment.

Qualifications

• Ph.D. in toxicology, pharmacology, or related sciences; DABT certification is desired but not required.
• 15+ years of pharmaceutical consulting and/or pharmaceutical industry and/or government experience (e.g., FDA).
• Deep understanding of ICH and regulatory guidance for nonclinical drug development.
• Experience writing regulatory documents (pre-IND, IND/CTA, BLAs/NDAs) and interacting with regulatory agencies.

Responsibilities

• Address scientific, regulatory, and business challenges in pharmaceutical/biopharmaceutical development.
• Oversee nonclinical safety programs and interpret TK/PK/PD data.
• Serve as toxicology representative on project teams.
• Participate in meetings with global regulatory authorities.
• Write or supervise writing of nonclinical sections of regulatory submissions.
• Contribute to due diligence for in- and out-licensing and present at toxicology meetings.
• Travel up to ~20% may be required.

Skills

Project management

Written and verbal communication

Independent work

Multidisciplinary teamwork

Education

Ph.D. in toxicology/pharmacology

DABT certification (desirable)

Job description

BlueRidge Life Sciences is seeking an experienced toxicologist (15+ years biopharmaceutical/pharmaceutical experience) to join our expanding Pharmaceutical toxicology consulting practice. This role involves designing nonclinical safety programs and collaborating across teams.

You will interact with regulatory authorities, write regulatory sections, and lead studies from pre-IND to NDA, with opportunities for professional development and leadership in a dynamic, multidisciplinary environment.