Life Sciences & Technology
| Clinical Research & Clinical Affairs
A BDN client is looking for a Medical Director for Clinical Development. This individual will provide medical and scientific support within clinical development for products within the assigned therapy area (Rare Diseases – CMV infection post-transplant). They will also ensure that regulatory authority requirements and quality standards are met. This individual will review data generated in phase III trials, and provide oversight of the CRO medical monitoring and safety coding for client sponsored clinical research programs. This person will also collaborate with the Global Clinical Development Lead, Clinical Scientists, Global Program Lead and Clinical Operations to ensure that all development and product support activities for the therapeutic area(s) are coordinated and consistent. This individual will provide scientific advice within the client's R&D group and in support of brands and product launches. He/she will interact with clinical development partners such as Clinical Operations, Regulatory, Commercial, Compliance, and Business Unit management teams. Additional duties will include reviewing clinical protocols and clinical study reports for scientific and medical accuracy. This person should demonstrate expertise in data review and interpretation of phase III trials to deliver meaningful efficacy and safety conclusions, as well as demonstrate the ability to interpret conclusions in the context of product profiles and medical practice. Stand-out candidates will have at least 3 years of experience in medical monitoring, including coding review of adverse events and experience with data review. An M.D. degree is preferred for this position.