Director, CDx Regulatory Strategy & Consulting

Precision for Medicine; Germany (OH); On-site; USD 180,000 - 240,000; Full time

Job summary

Precision Medicine Group is seeking a Director, CDx Regulatory Consultant to apply deep expertise in companion diagnostic regulatory strategy, IVD development, and global marketing authorization pathways. You will translate FDA, EU IVDR, and other global requirements into practical actions, shaping Rx Dx co-development and commercialization programs.

Lead cross-functional teams, guide regulatory submissions, and drive lifecycle management for diagnostic programs.

Qualifications

• 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.
• 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.

Responsibilities

• Develop global CDx regulatory strategies and integrated development roadmaps for pharmaceutical, biotechnology, and diagnostic clients.
• Lead consulting engagements to design submission pathways, milestones, and regulatory strategies supporting clinical trial execution and commercialization.
• Coordinate with cross-functional teams to ensure CDx development aligns with regulatory expectations and program timelines.
• Advise clients on regulatory requirements for use of assays in clinical trials, including IRB considerations and global performance study obligations.
• Direct preparation of global regulatory submissions and supporting documentation for CDx programs (FDA, EU IVDR, etc.).
• Lead interactions with regulatory authorities and notified bodies, including FDA meetings and response strategies.
• Review and direct development of analytical validation plans, clinical performance study plans, and diagnostic protocols.

Education

Bachelor's degree in life sciences, molecular biology, genetics, pathology, laboratory medicine, regulatory affairs, or a related scientific discipline

Strong written and verbal communication skills

Strong leadership, team building, and interpersonal skills

Strong scientific and analytical skills

Ability to solve complex CDx regulatory, clinical trial assay, submission, and commercialization challenges

Job description

Precision Medicine Group is seeking a Director, CDx Regulatory Consultant to apply deep expertise in companion diagnostic regulatory strategy, IVD development, and global marketing authorization pathways. You will translate FDA, EU IVDR, and other global requirements into practical actions, shaping Rx Dx co-development and commercialization programs.

Lead cross-functional teams, guide regulatory submissions, and drive lifecycle management for diagnostic programs.