Director, CDx Regulatory Consultant

Role Overview

• 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.
• 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.
• Serve as the CDx regulatory subject matter expert for strategic positioning of client programs.
• 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.

Requirements

• Bachelor’s degree in life sciences, molecular biology, genetics, pathology, laboratory medicine, regulatory affairs, or a related scientific discipline; equivalent relevant experience may be considered.
• Minimum 5 years of applicable consulting experience with a primary focus in IVD, companion diagnostic, clinical trial assay, or precision medicine regulatory affairs.
• Minimum of 7 years of experience in an in vitro diagnostic, companion diagnostic, pharmaceutical, or regulatory consulting environment.
• Direct experience working with diagnostic manufacturers/labs and pharmaceutical sponsors to design global regulatory and commercialization strategies for companion diagnostics and clinical trial assays.
• Strong written and verbal communication skills, with demonstrated ability to translate complex CDx regulatory requirements into clear, practical recommendations for clients and cross-functional teams.
• Strong scientific and analytical skills, including the ability to interpret biomarker, assay validation, clinical performance, and diagnostic clinical trial information in support of CDx regulatory strategy.
• Ability to solve complex CDx regulatory, clinical trial assay, submission, and commercialization challenges with practical, risk-based solutions.
• Strong leadership, team building, and interpersonal skills, including the ability to guide multidisciplinary teams across diagnostic development, therapeutic development, regulatory, quality, clinical, laboratory, and commercial functions.

Benefits

• discretionary annual bonus
• health insurance
• retirement savings benefits
• life insurance
• disability benefits
• parental leave
• paid time off for sick leave and vacation