Manager, Companion Diagnostics (CDx) DevelopmentClear Point Consultants • Boston, MA, United States

Manager, Companion Diagnostics (CDx) Development

Clear Point Consultants • Boston, MA, United States

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The Manager of Companion Diagnostics (CDx) and In Vitro Diagnostics (IVD) Development will lead the transition of investigational diagnostic devices (IDEs) from clinical development to full commercialization. This role serves as the subject matter expert for CDx development, bridging clinical, regulatory, and quality functions to ensure diagnostics are developed, validated, and brought to market in alignment with drug development programs. The ideal candidate combines scientific expertise, regulatory acumen, and hands-on experience with diagnostic partnerships to drive innovation and compliance in precision medicine.

Key Responsibilities :

Lead the strategic and operational transition of IDEs from clinical development to commercial CDx and IVD products.
Serve as the primary liaison between therapeutic program teams, diagnostic developers, and regulatory stakeholders.
Oversee and provide technical guidance to CDx development partners to ensure end-to-end compliance and delivery.
Identify and mitigate risks or process gaps across the CDx development lifecycle—from discovery through commercialization.
Support the design, execution, and interpretation of analytical and clinical validation studies for CDx approval.
Develop and maintain Quality Agreements and SOPs defining roles, responsibilities, and expectations between drug sponsors and CDx partners.
Collaborate with Regulatory Affairs to ensure adherence to global CDx and IVD regulations and submission requirements.
Provide input on biomarker strategy, diagnostic assay selection, and validation plans to support clinical development.
Ensure documentation and deliverables meet regulatory and internal quality standards.

Qualifications :

Bachelor’s degree in a scientific, biomedical, or allied health discipline; advanced degree preferred.

Minimum of 6+ years of experience in diagnostic development, including 3+ years in Companion Diagnostics (CDx) or In Vitro Diagnostics (IVDs).

Proven experience as a CDx developer and / or drug sponsor, with deep understanding of both perspectives.

Strong knowledge of global CDx / IVD regulatory frameworks (FDA, EMA, PMDA, etc.) and quality management systems.

Expertise in end-to-end CDx development, including assay design, analytical and clinical validation, and commercialization.

Demonstrated success in managing partnerships with diagnostic or technology development organizations.

Excellent communication, documentation, and stakeholder engagement skills.

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