Back to Job Search

Directory, Toxicology

Posted 24 days ago

  • Sector: Pharmaceutical, Biotech
  • Contact: Stefanni LaJeunesse
  • Contact Email: s.lajeunesse@sciproglobal.com
  • Expiry Date: 12 May 2021

The Director of Toxicology will: 

  • Plan and design all nonclinical studies, including non-GLP and GLP studies (safety pharmacology and toxicology studies), primarily through contract research organizations (CROs).

  • Manage the budget for non-clinical safety studies.

  • Manage contracts and coordinate activities with CROs; Serve as study monitor.

  • Prepare study reports and regulatory documents, including investigator’s brochures, INDs and NDAs.

  • Contribute to and participate in meetings and interactions with regulatory agencies.

  • Work closely with other functional areas such as Biology, Medicinal Chemistry, DMPK, CMC and Clinical.

  • Provide strategic preclinical expertise to cross-functional project teams as the in-house preclinical expert.

Requirements

  • Ph.D. in toxicology, pharmacology, physiology, biology, or related discipline

  • 10+ years of preclinical safety experience in the pharmaceutical/biotechnology industry experience

Preferred Experience 

  • Diplomate, American Board of Toxicology (DABT)

  • Demonstrated expertise in nonclinical study design and management with small molecule drug candidates

  • Demonstrated track record of successful regulatory filings

  • Adequate understanding and experience in PK/TK studies

  • Experience in contracting and managing safety studies with reputable CROs

  • Experience with pre-IND through Phase 1-3 programs and associated regulatory filings

  • Experience in working with U.S. and European regulatory authorities