Inovio is developing a new generation of immunotherapeutic agents, using synthetic DNA sequences as vaccines to treat and prevent cancers and infectious diseases. These SynCon® vaccines are designed to provide broad cross-strain protection against both known and newly emergent strains of pathogens such as influenza and break tolerance to tumor-associated antigens for the treatment of cancer. These vaccines, in combination with Inovio’s proprietary electroporation delivery devices, have been shown to be safe and generate significant immune responses and clinical efficacy. Inovio’s clinical programs include HPV/cervical dysplasia and cancer (therapeutic), chronic hepatitis B (therapeutic), ebola virus (preventive and therapeutic), prostate, breast, lung and pancreatic cancer (therapeutic) and HIV vaccines (both preventive and therapeutic).
The clinical trial manager will be responsible for overall clinical study conduct of Inovio and investigator sponsored research, including verification of source documentation versus Case Report Forms to ensure accurate and complete data and compliance with protocol(s) and Federal regulations, ICH, & GCPs, and local requirements. Duties may also include oversight of clinical trial operations as performed by a CRO or other external consultants.
Summary of essential job functions
Excellent oral and written communication skills, attention to detail and ability to interact effectively with management and prioritize diverse projects for multiple disciplines.
Thorough knowledge of all applicable regulations, including FDA, ICH and ISO guidelines. Medical device experience a plus.
Up to 20%, primarily domestic.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Inovio offers an attractive benefits package and is an equal opportunity employer.