Director, CDx Regulatory Consultant

This is a fully remote position, open to applicants in Germany.

📋 Description

• The Director, CDx Regulatory Consultant will leverage extensive expertise in companion diagnostic regulatory strategy, IVD development, quality system requirements, and global marketing authorization pathways to provide guidance to pharmaceutical, biotechnology, and diagnostic clients on the development, clinical trial utilization, approval, and lifecycle management of companion diagnostics.

• Interpret intricate FDA, EU IVDR, and other global regulatory stipulations into practical, actionable strategies that facilitate Rx Dx co-development, patient selection assays, analytical and clinical validation planning, clinical trial enabling submissions, and synchronized diagnostic and therapeutic commercialization.

• Act as the CDx regulatory subject matter expert for the strategic positioning of client programs encompassing CDx, including pertinent FDA precedents, EU IVDR considerations, global submission expectations, and diagnostic commercialization pathways.

• Anticipate client needs by comprehending the therapeutic program, biomarker strategy, intended use population, assay technology, clinical trial design, and commercial goals.

• Lead consulting projects with pharmaceutical clients to devise comprehensive global CDx regulatory strategies, integrated development roadmaps, submission pathways, and milestone-based timelines that aid clinical trial execution, regulatory approval, and commercialization targets.

• Collaborate cross-functionally with therapeutic development teams, diagnostic manufacturers, laboratories, biostatistics, clinical operations, quality assurance, and commercial stakeholders to ensure that CDx development activities are aligned with overall program timelines and regulatory standards.

• Formulate integrated Rx Dx regulatory strategies that synchronize diagnostic development, biomarker strategy, clinical trial enrollment, therapeutic development milestones, and commercialization goals for pharmaceutical, biotechnology, and diagnostic clients.

• Counsel clients on regulatory prerequisites for utilizing 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.

• Oversee the preparation of global regulatory submissions and supporting documents 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.

• Manage 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 formulation 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.

• Implement 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.

• Remain up-to-date 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.

⛳️ Requirements

• Bachelor’s degree in life sciences, molecular biology, genetics, pathology, laboratory medicine, regulatory affairs, or a related scientific field; equivalent relevant experience may be accepted.

• At least 5 years of relevant consulting experience primarily focused on IVD, companion diagnostic, clinical trial assay, or precision medicine regulatory affairs.

• A minimum of 7 years of experience in an in vitro diagnostic, companion diagnostic, pharmaceutical, or regulatory consulting setting.

• Direct experience collaborating with diagnostic manufacturers/labs and pharmaceutical sponsors to develop global regulatory and commercialization strategies for companion diagnostics and clinical trial assays.

• Excellent written and verbal communication skills, with a proven ability to convey complex CDx regulatory requirements into clear, practical recommendations for clients and cross-functional teams.

• Strong scientific and analytical capabilities, including the ability to interpret biomarker, assay validation, clinical performance, and diagnostic clinical trial data to support CDx regulatory strategy.

• Proficient in addressing complex CDx regulatory, clinical trial assay, submission, and commercialization challenges with practical, risk-based solutions.

• Robust leadership, team-building, and interpersonal skills, with the capacity to guide multidisciplinary teams across diagnostic development, therapeutic development, regulatory, quality, clinical, laboratory, and commercial domains.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health and wellness benefits package.

• Opportunities for professional development and continuous learning.

• Flexible work environment and schedule.