Senior Medical Director, Clinical Development

The Senior Medical Director will report into the Vice President, Clinical Development. You will be responsible for working within Celcuity ’s medical team providing medical oversight of service suppliers driving on-going clinical studies and plans and executes the study design protocol development, implementation and monitoring of the company’s new Phase I-III Oncology clinical trials. The position will provide key overall clinical, scientific and/or logistical support to clinical development programs and is responsible for the compliance of the department and the company to regulatory standards and procedures. 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 oversees clinical interpretation of study data. Track emerging efficacy and safety profile of drugs in on-going clinical trials; inform Clinical Development team of changes in the efficacy/safety and/or risk benefit profiles as they occur. Provide input and/or prepare clinical sections of regulatory documents (e.g., INDs, IND annual reports, Investigator’s Brochures, CRFs, Informed Consent forms, Statistical Analysis Plans, Data Management edit check specs, cli