Posted on Apr 6, 2021 by ChemoCentryx
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.
- Ph.D. in toxicology, pharmacology, physiology, biology, or related discipline
- 10+ years of preclinical safety experience in the pharmaceutical/biotechnology industry 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
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