Precision for Medicine - 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
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.
Benefits
• Reasonable estimate of the current range • $162,000—$243,000 USD • 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.
Apply in one click
Upload My Resume
Drop here or click to browse · Tap to choose · PDF, DOCX, DOC, RTF, TXT