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Director, Toxicology

Posted on Apr 6, 2021 by ChemoCentryx

Mountain View, CA 94042
Research
Immediate Start
Annual Salary
Full-Time


We are searching for a Director of Toxicology responsible for all aspects of preclinical development including the design, execution, management and regulatory submissions of all non-clinical safety studies during the course of preclinical development and clinical development of the company's drug development programs. This Director will report to the Vice President of DMPK/Toxicology and will work out of our brand new state-of-the-art corporate center.


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

  • Strong critical thinking and analytical skills

  • Excellent communication and presentation skills

  • Excellent team management skills




Reference: 1152691280

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