Director or Sr Director, Nonclinical Safety (Toxicology)

Salary $220,000-260,000 base salary
LocationCambridge
Employment type Permanent
Discipline

Job description

Job Title: Director / Senior Director, Nonclinical Safety (Toxicology)

Location: Cambridge, MA

Role Overview: We seek a Director/Senior Director of Nonclinical Safety (Toxicology) to lead safety strategy from discovery through clinical stages, directing all phases of toxicology studies in collaboration with project teams, CROs, and consultants.

Key Responsibilities:

  • Develop and implement nonclinical development plans and toxicology study designs (non-GLP and GLP).
  • Monitor and oversee nonclinical toxicology studies, including genetic, safety pharmacology, general, and reproductive toxicology.
  • Manage consultants and CROs, ensuring efficient governance, compliance, and alignment with regulatory guidelines.
  • Prepare nonclinical safety documents for regulatory filings (IND, annual updates, IB, DSUR, and briefing books).
  • Respond to regulatory inquiries from US FDA, EU, Japan, and other health authorities.
  • Collaborate with CMC, Program Management, Clinical, and Regulatory Affairs to support drug development.
  • Represent Nonclinical Safety in cross-functional project teams.

Qualifications:

  • PhD or DVM in Toxicology/Pathology with 10+ years of industry experience.
  • Expertise in nonclinical GLP toxicology and safety assessment of small molecule drugs.
  • Strong leadership, communication, and organizational skills.
  • DABT certification preferred.
  • Ability to navigate and lead in a dynamic environment.