Senior Toxicology Leader — Pharma & Regulatory Strategy

BlueRidge Life Sciences; Baltimore (MD); On-site; USD 200,000 - 260,000; Full time

Job summary

BlueRidge Life Sciences is seeking an experienced toxicologist (15+ years in biopharmaceuticals) to join the ToxStrategies consulting practice. The role involves designing and overseeing nonclinical safety programs, interpreting data for regulatory authorities, and writing regulatory sections for INDs/NDAs.

You will collaborate with toxicologists, epidemiologists, engineers, and biostatisticians, with opportunities for leadership and professional development in a fast-growing, multidisciplinary

Qualifications

• Ph.D. in toxicology, pharmacology or related sciences.
• DABT certification is desirable but not required.
• Minimum 15+ years of pharmaceutical consulting/industry/government/CRO experience.
• Strong understanding of ICH and regulatory guidance for nonclinical drug development.
• Experience writing regulatory sections and interacting with regulatory agencies.

Responsibilities

• Address scientific, regulatory, and business challenges in developing pharmaceutical/biopharmaceutical products.
• Oversee design, data interpretation, and monitoring of toxicology studies; interpret safety data.
• Serve as toxicology representative on project teams and participate in global regulatory meetings.
• Draft or supervise pharmacology/toxicology sections of regulatory submissions (pre-IND, IND/CTA, NDA/BLA).
• Prepare expert opinions, waiver requests, presentations, and proposals.
• Engage in due diligence for in- and out-licensing opportunities.
• Attend toxicology meetings (ACT, SOT); contribute to reports, publications, and committees.
• Lead business development efforts to attract new projects/clients.
• Travel may be required up to ~20%.

Skills

Project management

Written and verbal communication

Independent working

Team collaboration

Scientific leadership

Regulatory trend awareness

Education

Ph.D. in toxicology/pharmacology

DABT certification (desirable)

Job description

BlueRidge Life Sciences is seeking an experienced toxicologist (15+ years in biopharmaceuticals) to join the ToxStrategies consulting practice. The role involves designing and overseeing nonclinical safety programs, interpreting data for regulatory authorities, and writing regulatory sections for INDs/NDAs.

You will collaborate with toxicologists, epidemiologists, engineers, and biostatisticians, with opportunities for leadership and professional development in a fast-growing, multidisciplinary