At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) mission. We’re a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer’s disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
The Director of Companion Diagnostics Development will support in the development and implementation of strategies for current and next-generation clinical diagnostics products in support of therapeutic targets or as standalone diagnostics. Evaluating and implementing technologies for companion diagnostics programs and products to support clinical trials and commercialization. This position is responsible for strategy development of companion diagnostic and management of direct reports in various functions including biorepository management, data management, process transfer, project management, CRO and manufacturing.
Development of companion diagnostic (CDx)
Manage external diagnostic collaborations
Preparation of regulatory submitted document and contact with regulators
Assist in establishing new collaborations
Formulating global diagnostics strategies
Implement a clinical sample biobank
Prepare regular updates on diagnostic initiatives
Collaborate closely with colleagues in R&D, Clinical and other functions as well as the global commercial organization.
Assist in assessing and implementing technologies, patents and companies that may be appropriate for specific companion diagnostic strategies and serve to coordinate efforts throughout network of product creation units.
Interface with and managing external diagnostic companies, CRO’s and other partners/service providers that have technologies that may support each program's specific objectives.
Development and implementation of a secure clinical sample biobank that complies with all regulatory and legal requirements associated with such samples
Other duties as assigned
Minimum BS with 10-15+ years experiment of oncology therapeutic area in the diagnostics industry.
Experience in assessing diagnostics technologies in a Business Development function.
Experience in the process of developing and obtaining approval for diagnostics in a regulated setting.
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
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