1. Drafting of clinical scientific documents such as clinical section of IND, IND amendments Investigator Brochures, Annual Reports, Clinical Study reports, safety update reports and other FDA submissions, Risks / benefits analysis for applicable documents

2. Partner with clinical operations and other functional areas for the successful implementation and execution of clinical studies. Provide scientific expertise for selection of investigator and vendors. Monitor, review and summarize safety and efficacy data in ongoing studies

3. Develop relationships with appropriate consultants, contribute to or perform therapeutic area/indication research and competitor analysis

4. Interpret clinical data, prepare abstracts and present data at scientific meetings, both internally and externally

5. Development of protocols for clinical studies

1. A medical degree (M.D./Ph.D, M.D., D.O., or equivalent) with significant scientific research experience required

2. Minimum of 10 years of experience in clinical research (including medical affair) with at least 5 or more years of drug development experience within other biotech / pharmaceutical companies are required

3. Prior industry Oncology Drug Development experience a plus, specifically experience in conducting phase I/II clinical trial and deep understanding of relevant regulatory health authority expectations and regulations

4. Ability to multi-task and work in a fast-paced environment