A Black Diamond client is seeking a Regulatory Pre-Clinical Strategist to complete their application to obtain a license for animal testing on an early phase II drug. This drug is a platelet-derived hemostatic agent for control of noncompressible hemorrhage (provide human platelets that will stop bleeding). The product has a shelf life at room temp for three years, where normal blood can be stored refrigerated for only 3-5 days. It is crucial that this individual has led non-clinical animal studies and has the regulatory knowledge to negotiate with the FDA to receive the license. The client’s specific therapeutic area is Hematopoietic Acute Radiation Syndrome (H-ARS) – they are looking for someone who has navigated this area before. This project is funded through BARDA for countermeasures to allow immediate and volume response to radiological disasters.
- Pre Clinical / Non-Clinical
- Animal Testing
Remote: Regulatory Pre Clinical Strategist (228536)