Senior Medical Director

Responsibilities

• Assist in design, author and/or review clinical study synopses, protocols, amendments, study reports and other study-related documents
• Act as a medical monitor for assigned study
• Discuss study design with investigators and key opinion leaders
• Provide clinical input for clinical protocol monitoring guidelines and analysis plans
• Drive clinical database design, data collection and cleaning and oversee clinical interpretation of study data
• Track emerging efficacy and safety profile of drugs in ongoing clinical trials
• Prepare clinical sections of regulatory documents including INDs, Investigator’s Brochures, and Informed Consent forms
• Lead or assist in the development of publications such as abstracts and manuscripts
• Identify, evaluate, and monitor vendors and clinical trial conduct
• Oversee and manage vendor activities and deliverables
• Present study results to the medical and scientific community

Requirements

• Medical Doctor (MD) degree
• Experience in solid tumor clinical trials
• 8-10 years of clinical development experience in pharmaceutical or biotechnology industry
• Phase I–III clinical trial experience
• Thorough knowledge of clinical trial design, methodology, and statistical concepts
• Working knowledge of the IND/NDA process
• In-depth knowledge of GCP/ICH guidelines
• Strong written and verbal English communication skills

Preferred Qualifications

• Recent experience in breast carcinoma
• Phase 3 clinical trial experience
• Experience with regulatory submissions
• Collaborative and team-oriented leadership style

About the Company

Celcuity is a clinical-stage, publicly traded biotechnology company seeking to extend the lives of cancer patients through the development of targeted therapies for the treatment of multiple solid tumor indications.