1.The candidate works with CROs in the execution and management of primarily Phase 1 & 2 clinical trials in the U.S.;
2.The successful candidate is provided with a lot of opportunity to be a manager and leader in clinical operations. The candidate must understand the drivers of study timelines, and offering solutions that can help the CRO execute trials efficiently, and “rolling up his/her sleeves” to drive results regardless of what is needed.
1.Manage US clinical trials through clinical study teams and through the use of CROs and internal resources;
2.Ability to risk-assess study goals, timelines and other study assumptions and compare CRO plans against company goals;
3.Planning, starting, and completing Phase 1 and 2 studies with aggressive timelines and goals;
4.Responsible for high-level oversight of 1-3 compounds/programs within clinical development;
5.Oversee the tactical implementation of clinical development plan for all assigned clinical programs by managing the site contracts, budgets, timelines, clinical trial vendors, CRO resources, patient enrollment and site activities;
6.Responsible for oversight and strategic direction and implementation across projects to ensure clinical programs are conducted to meet corporate goals, milestones, and budgets through close partnership with parties involved both inside and outside of the company;
7.Compile and maintain regular status reports of study progress and study specific timelines and ensure information is provided to project team leadership and senior management;
8.Maintains awareness of industry trends and developments to help define the future strategic direction for clinical trials design and execution;
9.Ensure clinical programs meet GCP and will pass corporate and regulatory authority audits;
10.Manage adverse event reporting, data clean up and study close out. Knowledge, Experience and Skills;
11.Must be independent, a self-starter, and have the ability to “rollup sleeves” to produce work-products;
12.Experience in oncology.