Senior Toxicology Consultant - Pharma Development Leader

BlueRidge Life Sciences; Pennsylvania; On-site; USD 190,000 - 230,000; Full time

Job summary

BlueRidge Life Sciences’ ToxStrategies division seeks an experienced toxicologist (15+ years) to lead nonclinical safety assessments for biopharmaceutical programs. You will oversee study design, data interpretation, and regulatory submissions, collaborating with regulators and cross-functional teams.

You will design safety programs, write regulatory sections, and engage with agencies while mentoring junior staff and contributing to business development.

Qualifications

• Ph.D. in toxicology, pharmacology, or related sciences.
• Minimum 15+ years of pharmaceutical consulting/industry/government experience.
• Solid knowledge of ICH and regulatory guidance for nonclinical development.
• Experience leading nonclinical safety programs through all development phases.
• Experience writing regulatory documents (pre-IND, INDs, BLAs/NDAs) and interacting with agencies.
• Strong project management and ability to manage multiple high-priority programs.
• Excellent written and verbal communication; able to work independently or in teams.
• Active involvement in scientific/toxicology professional organizations; recent presentations/publications.

Responsibilities

• Address scientific, regulatory, and business challenges associated with development of pharmaceutical/biopharmaceutical products
• Oversee study placement, design, data interpretation, and monitoring of toxicology studies, and interpret safety, TK/PK, and PK/PD data
• Serve as the toxicology representative on project teams
• Participate in meetings with global regulatory authorities
• Write or oversee writing of the pharmacology/toxicology sections of regulatory submission documents (e.g., pre-IND, IND/CTA, and NDA/BLA)
• Write or oversee writing of expert opinion reports, waiver requests, presentations, proposals, etc.
• Participate in due diligence meetings for in- and out-licensing
• Attend and present at toxicology meetings (e.g., ACT, SOT), serve on professional/scientific committees, and publish (papers, book chapters)
• Conduct business development activities to attract and develop new projects/clients
• Travel may be required (up to approximately 20%)

Skills

Project management

Scientific communication

Regulatory affairs

Independent work

Team collaboration

Education

Ph.D. in toxicology

DABT certification

Job description

BlueRidge Life Sciences’ ToxStrategies division seeks an experienced toxicologist (15+ years) to lead nonclinical safety assessments for biopharmaceutical programs. You will oversee study design, data interpretation, and regulatory submissions, collaborating with regulators and cross-functional teams.

You will design safety programs, write regulatory sections, and engage with agencies while mentoring junior staff and contributing to business development.