Associate Director, Non-Clinical Development Zogenix, Inc.

POSITION SUMMARY
The Associate Director of Non-Clinical Development will be responsible for developing and implementing non-clinical strategy for new drug product development at Zogenix. This person will also oversee and manage non-clinical studies at contract research organizations, as well as be responsible for writing non-clinical sections of regulatory submissions.

MAJOR AREAS OF RESPONSIBILITY
In collaboration with Zogenix Senior Development staff, lead development of non-clinical strategy and execute a plan to enable rapid drug product approval for Relday (risperidone-SABER-DosePro) and future drug products
Participate on drug product development teams by providing direction, oversight and management for all Zogenix non-clinical studies, and oversight for partner-conducted non-clinical studies, including Zohydro, Relday and all future drug products.
Work with Regulatory Affairs to write non-clinical sections of all regulatory submissions.

MINIMUM JOB QUALIFICATIONS
Self-motivated individual with the ability to think and work independently
Minimum of 9 years industrial experience in drug-device combination product development including experience managing a team and managing CROs
Experience in CNS and Pain non-clinical product development required, some experience in parenteral or controlled release non-clinical product development preferred
PhD in Toxicology, Pharmacology or a related discipline, or equivalent combination of education (MS or DVM) and drug product development experience. DABT certification a plus
Demonstrated success and experience working in a complex drug development environment
Excellent communication skills with ability to clearly express themselves both verbally and in writing
Strong understanding of ICH, FDA and EMEA guidelines pertaining to preclinical / nonclinical safety

PREFERRED JOB QUALIFICATIONS
Demonstrated success working effectively outside defined scope of responsibility, when required.
Have a bias for action and display a sense of urgency.
Possess strong skills in leadership, communication, project management and budget management while maintaining high quality and efficiency standards.

SPECIAL WORKING CONDITIONS
Up to 5-10 travel required

REPORTING RELATIONSHIP
Reports to Sr. Director, Product Development.

Location:	Emeryville, CA United States