Job Number: 413445
Associate Director Clinical Development
Lead successfully clinical trials Phase 1-3, develop and author the necessary documents (e.g.IND/CTA submissions, protocols, Investigator`s Brochures, Briefing books and regulatory responses, Clinical study reports, etc) and provide expert oncology clinical review of the study data and lead the publication of it.
Phd with pharma experience, IND and NDA experience a must in Oncology
Three or more years pharmaceutical industry clinical development experience in cancer research with knowledge of Phase I - III studies. Demonstrated competence as Study Director. Prefer candidate with experience working with FDA or EMA regulatory agencies handling responses to inquiries and requests for study related information. Prefer individual with broad experience and understanding of running clinical studies with experience in other Clinical Development functions such as Clinical Operations and Data Management. Must be a self-starter, self motivated and must also be effective in influencing others
Advanced Clinical - 20 months ago