Question – are you looking to be with a Company that is truly working on innovative approaches to cancer therapy – a company that already has products in clinical trials? You are!!! This Company is looking to expand their clinical group. Contact us now for additional details on this exciting opportunity.
MISSION STATEMENT:
Reporting to the Chief Medical Officer, the qualified candidate will be responsible for designing, planning, implementing and directing (Phase1, Phase 2 and Phase 3) clinical trials.
RESPONSBILITIES:
• Provide medical input and write relevant documents to ensure quality of study protocols and reports, Investigator Brochures and other scientific documents.
• Review Adverse Events (AEs) and Serious Adverse Events (SAEs) and document SAE narratives for the Clinical Study Report.
• Collaborate with Clinical Operations / Project Managers in the recruitment of clinical sites.
• Select and interact with principal investigators and be the principal liaison with consultants, opinion leaders and academic institutions in the oncology area.
• Lead the review, analysis and interpretation of study data.
• Provide medical input to Preclinical Development in order to ensure that the pharmacology and biomarker plans are adequately supporting the early clinical development plan
QUALIFICATIONS:
• MD
• Experience in oncology clinical development
• Working knowledge in GCP and ICH guidelines/practices.
• Strong communication skills (verbal and written)
• Project Management capabilities.
