Director, CDx Regulatory Consultant

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

📋 Description

• Act as the regulatory subject matter expert for CDx, strategically positioning client programs while considering FDA precedents, EU IVDR aspects, global submission requirements, and pathways for diagnostic commercialization.

• Anticipate client needs by comprehensively understanding the therapeutic program, biomarker strategy, target population, assay technology, clinical trial design, and commercial goals.

• Oversee consulting projects with pharmaceutical clients to formulate global CDx regulatory strategies, integrated development plans, submission routes, and milestone-driven timelines that facilitate clinical trial execution, regulatory approval, and commercialization goals.

• Collaborate cross-functionally with therapeutic development teams, diagnostic manufacturers, labs, biostatistics, clinical operations, quality assurance, and commercial partners to ensure that CDx development activities are synchronized with overall program timelines and regulatory expectations.

• Create cohesive Rx Dx regulatory strategies that harmonize diagnostic development, biomarker strategy, clinical trial enrollment, therapeutic development milestones, and commercialization objectives for clients in pharmaceuticals, biotechnology, and diagnostics.

• Provide guidance to clients on regulatory requirements regarding assay use in clinical trials, covering aspects such as patient selection, inclusion/exclusion testing, risk determinations, IRB considerations, investigational device requirements, and global performance study obligations.

• Oversee the preparation of global regulatory submissions and supporting documentation 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 submissions specific to different countries.

• Manage interactions with regulatory authorities and notified bodies, including preparation for FDA meetings, interpretation of agency feedback, strategy development for responses, meeting minutes, and follow-up communications on behalf of clients.

• Review and guide the creation of analytical validation plans, clinical performance study plans, diagnostic clinical protocols, statistical analysis synopses, technical reports, intended use statements, labeling, and other documents ready for submission related to CDx programs.

• Utilize expertise in IVD quality systems, design control, risk management, and post-market regulatory practices to support CDx readiness from early development through approval, launch, and lifecycle management.

• Remain informed on developments in CDx regulation, science, and the market, including FDA guidance, EU IVDR implementation, expectations from notified bodies, global regulatory trends, diagnostic precedents, and evolving requirements in precision medicine.

⛳️ Requirements

• A 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 with a primary emphasis on IVD, companion diagnostic, clinical trial assay, or precision medicine regulatory affairs.

• A minimum of 7 years of experience in environments related to in vitro diagnostics, companion diagnostics, pharmaceuticals, or regulatory consulting.

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

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

• Strong scientific and analytical abilities, including the capacity to interpret biomarker, assay validation, clinical performance, and diagnostic clinical trial data in support of CDx regulatory strategy.

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

• Strong leadership, team-building, and interpersonal skills, including the capability to guide multidisciplinary teams across diagnostic development, therapeutic development, regulatory, quality, clinical, laboratory, and commercial functions.

🏝️ Benefits

• Comprehensive health, dental, and vision insurance plans.

• Competitive salary with performance-based bonuses.

• Opportunities for professional development and career advancement.

• Flexible working hours and remote work options.