Associate Director, Companion Diagnostics Strategy Lead

Job description

Description: AbbVie is offering a unique opportunity for a highly motivated individual to join our team as an Associate Director, Companion Diagnostics Strategy Lead within the Precision Medicine Companion Diagnostics team, which supports CDx development across therapeutic areas (oncology/immunology/neuroscience). We are seeking a creative and highly motivated leader to develop and implement global diagnostic strategies to enable and support the global development and commercialization of innovative targeted therapies. The successful candidate will have the opportunity to work in a highly collaborative environment and will be a key member of multidisciplinary development project teams. Essential Duties and Job Functions: Lead the development and implementation of diagnostic strategies for individual projects and/or therapeutic areas Direct the development, outsourcing and validation of clinically applicable companion diagnostic assays for FIH and registrational studies Design, implement and oversee diagnostic testing and data analysis Provide expertise to development project teams to ensure access to state-of-the art thinking on appropriate diagnostic technologies, evaluating their scientific basis and clinical applicability, the validation status and any technical or statistical issues related to the proposed companion diagnostic assay Lead joint development teams between AbbVie and Dx partners to ensure successful fit for purpose CDx development and that co-development timelines are met Serve as subject matter expert in state-of-the-art biomarker testing technologies (immunohistochemistry, FISH, NGS, PCR, flow cytometry, etc) Will lead interactions with global health authorities regarding companion diagnostics development and submissions While the ideal work location will be based out of AbbVie's HQ in IL, candidates can also be based out of AbbVie's Waltham, MA location. PhD in Science or related field with 8+ years of related work experience. Experience and knowledge in the technical and regulatory aspects companion diagnostic development Cross-functional experience in commercial and or medical aspects of companion diagnostics is a plus Demonstrated excellence in independently leading and conducting research and ability to evaluate, interpret and present complex scientific data Experience in human translational research with biomarker application in clinical trials and awareness of the challenges of implementing diagnostic technologies in the clinical setting is desirable Excellent leadership skills including motivation and influencing without authority Excellent verbal and written communication and presentation skills in English High level of initiative and ability to work independently High level of business awareness Experience in Oncology therapeutic area is a PLUS