Associate Director, Companion Diagnostics Strategy

3 weeks ago


Waltham, Massachusetts, United States BioSpace, Inc. Full time
Job Summary

At BioSpace, Inc., we are seeking a highly experienced Associate Director, Companion Diagnostics Strategy to join our Precision Medicine Companion Diagnostics team. This role will be responsible for developing and implementing global diagnostic strategies to enable and support the global development and commercialization of medically differentiated therapies.

Key Responsibilities

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 BioSpace, Inc. and Dx partners to ensure successful fit-for-purpose CDx development and that co-development timelines are met
Serve as a 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

Requirements

Highly experienced biomedical professional (PhD or MD/PhD) with a minimum of 5-7 years of post-doctoral and/or relevant industry experience with expertise in oncology/immunology/neuroscience biomarker and/or companion diagnostic development
Experience and knowledge in the technical and regulatory aspects of 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 the Oncology therapeutic area is a plus

About BioSpace, Inc.

BioSpace, Inc. is a leading provider of innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas, including immunology, oncology, neuroscience, and eye care, and products and services in our Allergan Aesthetics portfolio. For more information about BioSpace, Inc., please visit our website.

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