1. Responsible for supporting the design and execution of clinical trials and associated data collection activities, within a therapeutic area.
2. Collaborate on, or lead where appropriate, the preparation of clinical study related documents including clinical study protocol concept sheets, protocols, charters, study operations manuals, statistical summary reports, meeting presentations and clinical sections of regulatory documents.
3. Support CRAs/CROs on study related questions and serve as point of contact for managing/answering questions relating to trial procedures.
4. Support development of publications arising from studies and other relevant initiatives.
5. Critically evaluate available information about diseases of interest to the therapeutic area and the competitive landscape and synthesize information succinctly to support dissemination and incorporation into clinical development programs, asset plans and therapeutic area strategy.
6. Advanced scientific degree (M.S., Ph.D., Pharm D., MPH or similar degree) required, with 3-5 years of experience in drug development in the biopharmaceutical industry, immune-oncology project experiences is strongly preferred.