Senior Toxicology Scientist Preclinical Safety Strategy

Apex Systems

Cambridge (MA)

On-site

USD 150,000 - 200,000

Full time

8 days ago
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Benefits offered by this job

Medical insurance
Dental insurance
Vision insurance
Life insurance
Disability insurance
ESPP
401K with company match
HSA
EAP
Discount program

Job summary

Everforth Apex Systems in Cambridge, MA is seeking a Senior Scientist in Toxicology to shape the preclinical safety strategy for oligonucleotide programs across all development stages, influencing discovery, development, and regulatory decisions with cross‑functional teams.

You will serve as Study Director for GLP and non‑GLP toxicology studies in rodent and non‑rodent species, manage CRO relationships, and author nonclinical sections of regulatory submissions.

Qualifications

  • PhD in toxicology or related field with 3+ years of industry experience or BS/MS with 10+ years of experience.
  • Experience with nonclinical development of antisense oligonucleotides or siRNA.
  • Strong understanding of GLP requirements and global regulatory guidelines (ICH, FDA, etc.).

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

Skills

Toxicology
GLP Compliance
CRO Management
Regulatory Knowledge
Communication

Education

PhD in Toxicology or related field

Job description

Everforth Apex Systems in Cambridge, MA is seeking a Senior Scientist in Toxicology to shape the preclinical safety strategy for oligonucleotide programs across all development stages, influencing discovery, development, and regulatory decisions with cross‑functional teams.

You will serve as Study Director for GLP and non‑GLP toxicology studies in rodent and non‑rodent species, manage CRO relationships, and author nonclinical sections of regulatory submissions.

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