Director Preclinical Safety - Mountain View, CA | Biospace
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Director Preclinical Safety

ChemoCentryx, Inc.

Location:
Mountain View, CA
Posted Date:
11/14/2016
Position Type:
Full time
Job Code:
Salary:
190,000
Required Education:
Doctorate/PhD
Areas of Expertise Desired:
Biochemistry, Biotechnology, Clinical Trial, Director, DMPK, Drug Safety, Pharmacovigilance, PhD, Toxicology,

Job Description

Position: Associate Director / Director / Senior Director, Preclinical Safety
Company Description:
ChemoCentryx 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


Requirements

PhD
All aspects of clinical development
Demonstrated track record of success
Experience with US and European Regulatory Agencies
Experience with pre-IND and Phase 1-3 trials