Senior Pharmaceutical Toxicologist – Consulting Expert

BlueRidge Life Sciences; Elm (PA); Sur place; USD 180 000 - 240 000; Plein temps

Résumé du poste

BlueRidge Life Sciences is seeking an experienced toxicologist to join our Pharmaceutical toxicology consulting practice. The role focuses on designing, overseeing nonclinical safety programs, and interfacing with regulatory authorities across drug development stages.

The candidate will lead writing of pharmacology/toxicology sections for regulatory submissions and collaborate with a multidisciplinary team of scientists to deliver science-driven solutions.

Qualifications

• Ph.D. in toxicology, pharmacology, or related sciences; DABT certification is desired but not required.
• Minimum 15+ years in pharmaceutical consulting and/or pharmaceutical industry and/or government (e.g., FDA).
• Deep understanding 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 skills with ability to balance multiple high-priority projects.

Responsabilités

• Oversee nonclinical safety assessment programs for drug candidates.
• Interpret and integrate safety, TK/PK, and PK/PD data across studies.
• Write or supervise regulatory sections of submissions (pre-IND, IND/CTA, NDA/BLA).
• Interact with regulatory authorities (e.g., FDA, EMA).
• Lead cross-functional teams including toxicologists, epidemiologists, engineers, and biostatisticians.

Connaissances

Toxicology

Pharmacology

Regulatory knowledge

Project management

Scientific communication

Formation

Ph.D. in toxicology or pharmacology

Description du poste

BlueRidge Life Sciences is seeking an experienced toxicologist to join our Pharmaceutical toxicology consulting practice. The role focuses on designing, overseeing nonclinical safety programs, and interfacing with regulatory authorities across drug development stages.

The candidate will lead writing of pharmacology/toxicology sections for regulatory submissions and collaborate with a multidisciplinary team of scientists to deliver science-driven solutions.