Precision Medicine Group - Director, IVD Regulatory Consulting

• 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. • Preferred: • Master’s degree or higher in life sciences, molecular diagnostics, regulatory affairs, public health, laboratory medicine, pathology, or a related discipline. • RAC certification