Manager/Associate Director, Preclinical Development - Hayward, CA | Biospace
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Manager/Associate Director, Preclinical Development

Arcus Biosciences

Location:
Hayward, CA
Posted Date:
9/1/2017
Position Type:
Full time
Job Code:
D-1705
Salary:
TBD
Required Education:
Masters Degree
Areas of Expertise Desired:

Job Description

This newly created position will report to the VP of Preclinical Development. The position level will reflect the amount of relevant experience. We are seeking someone passionate and fluent in the complex science of the preclinical characterization of drug candidates intended for study in humans, someone who can work in the context of the bigger picture while paying detailed attention to all aspects of preclinical characterization.


The Manager (or AD) of Preclinical Development will work closely with the rest of the Preclinical Development staff and will be responsible for overseeing the activities of Contract Research Organizations engaged in all aspects of the preclinical safety assessment (GLP and non-GLP studies) of Arcus’s drug candidates, which include small molecules as well as monoclonal antibodies. She/He will be involved in the design, placement, coordination and oversight of several concurrent preclinical development programs, working closely with the Clinical Development and Regulatory members of our team to ensure the timely generation of the knowledge and regulatory documents required to support the clinical evaluation of the selected molecules. She/He will participate in the generation of technical reports and regulatory documents in the areas of responsibility.

Requirements

The ideal candidate will hold an advanced degree (M.S., Ph.D. or M.D.) in a relevant life science, such as pharmacology, toxicology, pathology, medicine, etc.  The candidate will have a minimum of 5 years of relevant experience in high-quality drug development organizations. At least 2 of those years should reflect a set of responsibilities very similar to those associated with the current role.  She/He will have intimate knowledge of FDA/ICH GLP regulations and guidelines, a track record of concurrently managing multiple complex studies, and a demonstrated ability to adjust easily to multiple demands, shifting priorities, and unexpected events. Additional requirements include strong writing skills, experience authoring technical reports and regulatory documents, and experience with the selection, contract negotiation and management of multiple concurrent external relationships with CROs, consultants, and other vendors.