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

• 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