Precision Medicine Group - Director, CDx Regulatory Consultant
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. • Preferred: • Master’s degree or higher in life sciences, molecular diagnostics, regulatory affairs, public health, laboratory medicine, pathology, or a related discipline. • RAC certification • Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Responsibilities
• Lead client workshops, scientific conference sessions, and educational presentations focused on CDx development, Rx Dx co-development, clinical trial assay strategy, and global IVD regulatory requirements. • Ensure the quality, consistency, and regulatory accuracy of all CDx strategy documents, client deliverables, submissions, meeting materials, and other consulting work products in accordance with corporate standards. • Time entry and following SOPs • Manage, mentor, motivate, and develop regulatory consulting staff to support a scalable CDx and IVD regulatory consulting practice. • Support and contribute to a collaborative, client-focused consulting culture that advances Precision for Medicine’s CDx, IVD, and precision medicine regulatory capabilities.
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