Plymouth Meeting’s Inovio Pharmaceuticals is engaged in the development of a new generation of vaccines, called synthetic vaccines, focused on cancers and infectious diseases. Its clinical programs include cervical dysplasia (therapeutic), avian influenza (preventive), prostate cancer (therapeutic), leukemia (therapeutic), hepatitis C virus (HCV), and HIV vaccines.

Director of Regulatory Affairs

The primary responsibility of this position will be oversight of all regulatory affairs activities pertaining to the underlying strategy and conduct of Phase I-III clinical trials. He/she will assess the regulatory strategy for potential drug/biological development candidates, manage all IND submissions and meetings, manage regulatory agency communication and negotiation, and ensure compliance with all international regulatory requirements.

The ideal candidate will possess a Ph.D., M.D., or Pharm. D. with extensive experience in vaccine development. He/she will have a minimum of 10 years in regulatory affairs with biopharmaceutical products, with a minimum of five years in another aspect of biopharmaceutical product development. Knowledge and/or experience in one or more of the following fields: oncology, infectious diseases, molecular biology, or immunology.

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Outsourcing Manager, Clinical Operations

This positon will be a member of the clinical project team and be responsible for the generation, negotiation, and execution of clinical trial vendor contracts. The individual will ensure that the contract terms, statement of work (SOW), and budget meet the needs of both the clinical trial and all legal requirements. He/she will also be responsible for managing and facilitating any change orders to the SOW.

The ideal candidate will have a Bachelor’s Degree in a scientific or business discipline, and have three to five years of procurement/category management expertise in a clinical research setting. He/she should have knowledge of GCP and regulatory requirements regarding clinical trial management.

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Senior Product Development Associate

This is a position that interfaces with research, engineering, product development, and clinical development groups. He/she will collect, analyze, and present data at both internal meetings with other Inovio scientists and collaborators, as well as at external scientific meetings. The person will also perform program/project management tasks to facilitate pre-clinical to clinical development of vaccine candidates.

The ideal candidate will have a Master’s Degree in Immunology or a related field, and have at least one year of industry experience in a research and/or development environment. Working knowledge of SPSS or a comparable statistical software package is required, as are technical writing, verbal communication, and oral presentation skills.

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