The Director of Clinical Sciences will provide leadership in the areas of clinical laboratory management, study design and assay development. This person will work with Research and Development, Clinical Development, Product Development, Business Development, and Regulatory groups to provide input a to successfully integrate and translate product requirements into cohesive, clinically and medically-relevant products. This would include input on clinically related RUO products as well as those IVD products undergoing regulatory submission.
- Provide strategic leadership for the development of assays from research to validated clinical assays.
- Provide strategic leadership for the development of diagnostic products. Primary responsibility will be to successfully integrate and translate product requirements into cohesive and medically-relevant products. This would include clinically relevant RUO products as well as products undergoing regulatory submission.
- Provide strategic and technical leadership for designing and implementing studies for support of medically and clinically relevant products. This would include studies for analytic parameters (sensitivity and specificity) and clinical trials for the development of products.
- Provides specific scientific expertise based on his/her molecular biology, chemistry, biologic, or other scientific training.
- Effectively identify, evaluate, and manage external partners and technology in the areas of laboratory services, clinical development, data analytics, and software needs.
- Participate in the planning, writing, and implementation of laboratory focused clinical trials and collaborative studies.
- Author protocols, reports, pre-submissions, IDE and other PMA submission related documentation for molecular diagnostic applications.
- Coordinates and oversees the full implementation and execution of programs with external and internal collaborators within the accepted timelines, budgets and resources.
- Effective verbal and written communication with internal and external stakeholders including clients and regulators.
- Provide general intelligence on key developments in the diagnostics industry as well as current medical practice
- Willingness to travel up to 25% of the time