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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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