Senior Pharmaceutical Toxicology Leader

BlueRidge Life Sciences; New Jersey; On-site; USD 180,000 - 260,000; Full time

Job summary

BlueRidge Life Sciences is seeking a senior toxicologist with 15+ years of biopharmaceutical and pharmaceutical experience to join our ToxStrategies division. The role involves designing and overseeing nonclinical safety programs, interpreting safety data, and preparing regulatory submissions for IND/CTAs, BLAs/NDAs, and related documents for regulatory authorities (FDA, EMA, MHRA).

The successful candidate will work with leading toxicologists, epidemiologists, and biostatisticians in a

Qualifications

• Ph.D. in toxicology, pharmacology, or related sciences; DABT certification is desired but not required.
• Minimum 15+ years of pharmaceutical consulting/industry/government experience (FDA or CROs).
• Deep understanding of ICH and regulatory guidance for nonclinical drug development.
• Experience leading nonclinical safety programs through all development phases (pre-IND to marketing).
• Experience writing regulatory documents (pre-IND, INDs, BLAs/NDAs) and interacting with agencies.
• Strong project management with ability to manage multiple high-priority programs.

Responsibilities

• Oversee nonclinical safety assessment programs for drug candidates.
• Interpret and integrate safety, TK/PK, and PK/PD data across studies.
• Write or oversee nonclinical sections of regulatory documents (e.g., pre-IND, IND/CTA, NDA/BLA).
• Interact with regulatory agencies (e.g., FDA, MHRA, EMA).
• Lead business development efforts to attract new projects and clients.
• Travel up to 20% may be required.

Education

Ph.D. in toxicology or related sciences

DABT certification (desired)

Job description

BlueRidge Life Sciences is seeking a senior toxicologist with 15+ years of biopharmaceutical and pharmaceutical experience to join our ToxStrategies division. The role involves designing and overseeing nonclinical safety programs, interpreting safety data, and preparing regulatory submissions for IND/CTAs, BLAs/NDAs, and related documents for regulatory authorities (FDA, EMA, MHRA).

The successful candidate will work with leading toxicologists, epidemiologists, and biostatisticians in a