Join to apply for the Director, Precision Medicine, Companion Diagnostics role at Regeneron
We are seeking a Director to join our Precision Medicine team. The Director, Precision Medicine will lead Companion Diagnostics (CDx) strategy, working closely with the Senior Director, Precision Medicine CDx and key cross-functional collaborators to deliver innovative diagnostics solutions supporting Regeneron programs. The primary role involves guiding strategy for patient selection/stratification, with a passion for immunohistochemistry (IHC), and leading the implementation and execution of CDx assays—from study conduct and sample management to launch—in collaboration with partners/IVD Sponsors and central testing laboratories within our oncology pipeline.
Key Responsibilities:
Define innovative diagnostic strategies, proposing projects from conception to implementation considering all relevant inputs.Develop strong relationships with IVD partners and testing laboratories.Oversee operational aspects of CDx clinical trial implementation, manage timelines, and communicate effectively internally and externally.Maintain relevant knowledge of regulatory requirements (including IVDR) and support regulatory teams from study setup to PMA filing, understanding Performance Study requirements, and making strategic decisions in coordination with IVD regulatory counterparts.Serve as a subject matter expert in oncology, effectively communicating with clinical study teams on program direction.Define and drive CDx strategy, gaining alignment across relevant partners, including senior management.Lead execution and implementation of Regeneron's CDx strategy in collaboration with key partners.Evaluate and select technologies and vendors to support diagnostic and program deliverables.Provide oversight for CDx programs, from contracting and sample logistics to data delivery.Qualifications:
- Ph.D. and/or M.D. with a minimum of 10 years postdoctoral experience, preferably in a pharmaceutical, biotech, academic, or governmental cross-disciplinary teams.
- Extensive experience in diagnostic development with success in a drug development setting.
- Deep understanding of technical, regulatory, clinical, and strategic aspects of diagnostic delivery.
- Strong knowledge of CDx, demonstrated success in delivering diagnostics, and experience in regulatory interactions and filings related to Precision Medicine.
Additional Information:
This role offers a salary range of $198,000 to $330,000 annually. Regeneron values diversity and inclusivity and is an equal opportunity employer. We offer comprehensive benefits, including health programs, fitness centers, equity awards, bonuses, and paid time off, depending on location.
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