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Precision for Medicine seeks a Director of Companion Diagnostic (CDx) Regulatory Consulting to lead strategic regulatory advisory services for pharmaceutical, biotechnology, and diagnostic clients developing companion diagnostics and in vitro diagnostic devices (IVDs).
In this role, you will serve as the CDx regulatory subject matter expert, translating complex FDA, EU IVDR, and global regulatory requirements into actionable strategies. You will lead consulting engagements to develop integrated Rx Dx regulatory strategies, clinical trial assay pathways, and commercialization roadmaps. Key responsibilities include:
**Consulting & Strategy:** Advise clients on companion diagnostic development, biomarker strategy, analytical and clinical validation planning, clinical trial enabling submissions, and lifecycle management. Lead preparation of global regulatory submissions (FDA Q-Submissions, Pre-IDE, IDE, PMA, EU IVDR Annex XIV applications) and direct interactions with regulatory authorities and notified bodies. Review and direct development of validation plans, clinical protocols, technical reports, and submission-ready documentation. Apply IVD quality system and design control expertise across the development lifecycle.
**Business Development:** Generate new CDx consulting opportunities through established pharma, biotech, and diagnostic relationships. Partner with BD team on RFP evaluation, risk assessment, and submission strategy definition. Support bid defense meetings and lead client workshops and scientific conference presentations on CDx development and global IVD regulatory requirements.
**Leadership & Operations:** Manage, mentor, and develop regulatory consulting staff to build a scalable CDx and IVD practice. Ensure quality, consistency, and regulatory accuracy of all deliverables and work products. Stay current on CDx regulatory developments, FDA guidance, EU IVDR implementation, and evolving precision medicine requirements.
You will work cross-functionally with therapeutic development teams, diagnostic manufacturers, biostatistics, clinical operations, quality assurance, and commercial stakeholders to ensure coordinated program execution.
