Director, CDx Regulatory Consultant

Position Summary:

The Director, CDx Regulatory Consultant will be responsible for applying deep expertise in companion diagnostic regulatory strategy, IVD development, quality system expectations, and global marketing authorization pathways to advise pharmaceutical, biotechnology, and diagnostic clients on the development, clinical trial use, approval, and lifecycle management of companion diagnostics. This role will translate complex FDA, EU IVDR, and other global regulatory requirements into practical, actionable strategies that support Rx Dx co-development, patient selection assays, analytical and clinical validation planning, clinical trial enabling submissions, and coordinated diagnostic and therapeutic commercialization.

Essential functions of the job include but are not limited to:

Consulting Services

• Serve as the CDx regulatory subject matter expert for strategic positioning of client programs inclusive of CDx, including relevant FDA precedents, EU IVDR considerations, global submission expectations, and diagnostic commercialization pathways.
• Proactively identify client needs by understanding the therapeutic program, biomarker strategy, intended use population, assay technology, clinical trial design, and commercial objectives.
• Lead consulting engagements with pharmaceutical clients to develop global CDx regulatory strategies, integrated development roadmaps, submission pathways, and milestone-based timelines that support clinical trial execution, regulatory authorization, and commercialization objectives.
• Partner cross-functionally with therapeutic development teams, diagnostic manufacturers, laboratories, biostatistics, clinical operations, quality assurance, and commercial stakeholders to ensure CDx development activities are coordinated with overall program timelines and regulatory expectations.
• Develop integrated Rx Dx regulatory strategies that align diagnostic development, biomarker strategy, clinical trial enrollment, therapeutic development milestones, and commercialization objectives for pharmaceutical, biotechnology, and diagnostic clients.
• Advise clients on regulatory requirements for use of assays in clinical trials, including patient selection, inclusion or exclusion testing, significant risk and nonsignificant risk determinations, IRB considerations, investigational device requirements, and global performance study obligations.
• Direct the preparation of global regulatory submissions and supporting documentation for companion diagnostics and clinical trial assays, including FDA Q-Submissions, Pre-IDE packages, IDEs, PMAs, PMA supplements, EU IVDR Annex XIV performance study applications, technical documentation, and other country-specific submissions.
• Lead interactions with regulatory authorities and notified bodies, including preparation for FDA meetings, interpretation of agency feedback, development of response strategies, meeting minutes, and follow-up communications on behalf of clients.
• Review and direct the development of analytical validation plans, clinical performance study plans, diagnostic clinical protocols, statistical analysis synopses, technical reports, intended use statements, labeling, and other submission-ready documents for CDx programs.
• Apply IVD quality system, design control, risk management, and post-market regulatory expertise to support CDx readiness from early development through approval, launch, and lifecycle management.
• Stay current on CDx regulatory, scientific, and market developments, including FDA guidance, EU IVDR implementation, notified body expectations, global regulatory trends, diagnostic precedents, and evolving precision medicine requirements.

Business Development

• Generate new CDx regulatory consulting opportunities through established relationship…