Sr. Scientist- Toxicology
Apex Systems · Cambridge, MA · 1 mo ago
AnalystContract
About the role
Our Cambridge based biotech client is looking for a highly motivated Senior Scientist in Toxicology to help shape the preclinical safety strategy for oligonucleotide programs across all stages of development. This role provides the chance to influence discovery, development, and regulatory decision‑making while working closely with cross‑functional teams.
Responsibilities
- Serve as Study Director for non‑GLP and GLP toxicology studies in rodent and non‑rodent species
- Manage CRO relationships, protocol development, and study execution
- Act as a subject matter expert on nonclinical safety topics
- Prepare and review safety pharmacology and toxicology reports
- Author nonclinical sections of regulatory submissions
Qualifications
- PhD in toxicology, pharmacology, or related field with 3+ years of industry experience or BS/MS with 10+ years of experience; DABT preferred
- Experience with nonclinical development of antisense oligonucleotides or siRNA
- Strong understanding of GLP requirements and global regulatory guidelines (ICH, FDA, etc.)
- Proven experience managing CROs and leading GLP/non‑GLP studies
- Excellent communication, organizational skills, and ability to thrive in a fast‑paced environment