- Responsible for developing and managing preclinical drug safety study programs for multiple drug development candidates. Manages contractor/collaborator relationships including evaluating potential CROs, negotiating contracts, establishing, approving and implementing and overseeing the execution of study protocols, data collection, and reporting activities.
- Identifies and recommends selection of contract organizations, negotiates contracts, designs and implements study protocols including all details from ensuring adequate supplies to the completeness and accuracy of all data in accordance with GLP regulations – Assists with developing budgets and monitors expenditures for CROs – Oversees ongoing studies including on-site monitoring at key stages – Reviews and edits study reports with responsibility for signing of protocol approvals, amendments, and final reports – Coordination of findings from in house research and safety studies with the design
- Participates in the development of project goals, strategies, and schedules.
- Assists with the preparation of data packages for submission to regulatory agencies.
- Interacts with members of other departments (e.g. manufacturing, regulatory, etc.) in order to ensure smooth and timely execution of preclinical studies and related regulatory filings.
- Contributes to scientific publications, presents at conferences and business meetings and participates in the development of patent applications.
- Experience with protocol development and analyzing, reviewing and preparing preclinical related reports
- MS (minimum) or PhD (preferred) degree in toxicology, pharmacology or biology
- 5+ years related industry experience including prior pharmaceutical development project management experience and familiarity with GLP and other regulatory guidelines
- Domestic travel
- Excellent verbal and written communication skills
- Proficiency in MS Office Suite including Word, Excel, and PowerPoint