Director, Toxicology (Consultant)

Added
16 hours ago
Type
Contract
Salary
Salary not provided

Related skills

regulatory affairs ich oncology ema fda

๐Ÿ“‹ Description

  • Develop nonclinical toxicology strategies for oncology drug development.
  • Design and interpret nonclinical safety studies (acute, chronic, repro, genetic).
  • Integrate animal, clinical, in vitro and in silico data for safety assessments.
  • Author toxicology sections for INDs, CTAs, and other regulatory submissions.
  • Support regulatory interactions with FDA, EMA, ICH and other agencies.
  • Manage external CROs and present findings to senior leadership.

๐ŸŽฏ Requirements

  • PhD, DVM or equivalent in toxicology or related field.
  • Board certification (DABT or equivalent) required.
  • 5+ years of toxicology experience in pharma or regulatory.
  • Strong knowledge of FDA, EMA and ICH regulations.
  • Excellent communication, collaboration, and project management skills.

๐ŸŽ Benefits

  • Remote consulting role based in India.
  • Flexible working environment with remote potential.
  • High-impact work across discovery and clinical development.
  • Collaboration with cross-functional teams and external CROs.
  • Influence on nonclinical strategy and risk assessment.
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