Head of Toxicology

Position Title:

Head of Toxicology

  Reports To:

VP, Chemistry

Dept. Name:

Toxicology

Position Summary:
The Head of Toxicology will be a key leader in the Preclinical Development group who oversees Toxicology activities and works in close collaboration with ADME and Clinical Pharmacology departments. This individual will be responsible for overseeing the Toxicology function and the analysis, interpretation and reporting of Safety Pharmacology and Toxicology data for Discovery and Development programs.
Duties & Responsibilities:
Essential duties and responsibilities include the following.  Other duties may be assigned.

  • The primary role is to lead the Toxicology group in the conduct, interpretation and reporting of Safety Pharmacology and Toxicology studies/data
  • Manage project assignments within the Toxicology function to ensure timely completion of priority activities
  • Critically evaluate toxicology results and provide strategic advice to project teams and senior management on the potential impact of toxicology results on Program and Clinical/Regulatory strategy
  • Oversee the preparation of Safety Pharmacology and Toxicology sections of regulatory documents (IND, NDA, briefing books, Investigator Brochures, etc.)
  • Represent Preclinical Development on discovery and development-stage program teams
  • Oversee the preparation of data summaries and presentations of results to peers, colleagues and management.
  • Prepare SOPs as needed to guide functional activities
  • Be knowledgeable with current regulatory guidance
Education / Experience:
  • Ph.D. in Toxicology, Pathology or closely related discipline or D.V.M. with at least 10 years of progressively responsible experience within the pharmaceutical/biotech industry
  • Knowledge/experience in toxicologic pathology is beneficial
  • Familiar with computational toxicology to help with predictive modeling is desired
  • Experience in managing preclinical Contract Research Organizations
  • Experience with preparation of INDs, CTDs, NDAs, and MAAs
  • Oncology experience is desired
  • Proactive, innovative, with good problem-solving skills
  • Experience working in a cross functional team and matrix environment
  • Excellent written, presentation, and verbal communication skills

Apply at jobs@erasca.com