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Position:
Director, Toxicology
Employer:
ChemoCentryx
Description:
Primary responsibilities include 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. You 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.
Qualifications/Experience:
Qualifications / Experience:
· Demonstrated expertise in nonclinical study design and management with small molecule drug candidates;
· Demonstrated track record of successful regulatory filings;
· Excellent understanding and experience in PK/TK studies;
· Excellent track record in successful contracting and managing safety studies with reputable CROs;
· Ph.D. in toxicology, pharmacology, physiology, biology, or related discipline. DABT preferred but not required;
· Minimum of 10 years of preclinical safety experience in the pharmaceutical/biotechnology industry experience;
· Experience with pre-IND through Phase 1-3 programs and associated regulatory filings;
· Experience in interacting with U.S. and European regulatory authorities in person, by teleconference and in correspondence;
· Experience in interacting with corporate partners in person, by teleconference and in correspondence;
· Highly motivated; well organized; multi-tasking;
· Strong critical thinking and analytical skills;
· Excellent communication and presentation skills;
· Excellent team management skills
Location:
Mountain View, CA
Contact:
hiring@chemocentryx.com
Post Date:
4/25/2019 8:28:34 AM
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