A small sized Biotech is searching for experienced individual with industry experience in Clinical Development. This person will overview Clinical and Operational process and help the company bring their product from early clinical stage into later stages.
-8 years Industry experience
-Experience in Oncology, Heamatology, Cell therapy
-Trial Design and Data Review experience
-Located in Europe
-Willingness for a fully hands on role
-Development of protocols for clinical studies.
-Contribute to the development of program strategy for assigned compounds/programs including
participation in the preparation of clinical development plans
-Drafting and review of clinical scientific documents such as IND, IND amendments, Investigator Brochures,
Annual Reports and other Health Authority submissions.
-Monitor, review and summarize safety and efficacy data in ongoing studies.
-Represent clinical development on project teams.
-Develop relationships with appropriate consultants and external experts and utilize these relationships to obtain feedback on protocol design.
-Clinical lead for study abstracts, posters, oral presentations and manuscripts for assigned studies.
-Serve as liaison to project teams, CRO's, Clinical sub-teams, and others.