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Position:
Director or Senior Director, Toxicology
Employer:
ChemoCentryx Inc.
Description:
ChemoCentryx, located in the San Francisco Bay Area (Mountain View; San Carlos), is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing orally-administered therapeutics to treat autoimmune diseases, inflammatory disorders and cancer, primarily focused on orphan and rare diseases.
Job 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:
- 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
- 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 working with U.S. and European regulatory authorities
- Highly motivated; well organized; multi-tasking
- Strong critical thinking and analytical skills
- Excellent communication and presentation skills
- Excellent team management skills
Location:
San Francisco Bay Area (Mountain View or San Carlos)
Contact:
smiao@chemocentryx.com
Post Date:
1/11/2021 3:29:09 PM
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