DMPK/Toxicology | San Carlos, CA | Full Time
ChemoCentryx is searching for a Director of Toxicology responsible for 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. This Director will report to the Vice President of DMPK/Toxicology and will work out of our brand new state-of-the-art corporate center in San Carlos, CA.
The Director of Toxicology 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.
- Ph.D. in toxicology, pharmacology, physiology, biology, or related discipline
- 10+ years of preclinical safety experience in the pharmaceutical/biotechnology industry experience
- Diplomate, American Board of Toxicology (DABT)
- 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
- Experience with pre-IND through Phase 1-3 programs and associated regulatory filings
- Experience in working with U.S. and European regulatory authorities
- Strong critical thinking and analytical skills
- Excellent communication and presentation skills
- Excellent team management skills
ChemoCentryx is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics to treat autoimmune diseases, inflammatory disorders and cancer, primarily focused on orphan and rare diseases. ChemoCentryx balances a passion for science with the deep-seated belief that patients suffering from serious diseases deserve more than incremental improvements to the length and quality of their lives.
At ChemoCentryx, our salary and benefits packages are among the most competitive in the industry. All our employees share the rewards of their work through a generous stock option program. We also offer 401K and Flexible Spending Accounts. ChemoCentryx employees enjoy a comprehensive benefits package including medical, dental and vision coverage as well as life insurance, and short and long-term disability insurance.