Clinical Assay & Precision Diagnostics Development Lead (m/w/d)

Summary: The role of Interim Head of Precision Diagnostics & Biomarker Strategy involves leading the development of a genetic diagnostic strategy within an innovative biotech environment. The successful candidate will manage the diagnostic roadmap, ensuring regulatory readiness and operational excellence across clinical studies. This position requires a blend of scientific expertise and strategic leadership to translate complex genomic algorithms into actionable diagnostic solutions. The assignment is freelance and expected to last at least six months with significant strategic visibility.

Key Responsibilities:

• Lead the development of a genetic diagnostic strategy impacting clinical development and market access.
• Own the end-to-end diagnostic roadmap from clinical trial assay strategy through validation and regulatory readiness.
• Drive interactions across clinical, regulatory, data science, and quality functions.
• Manage external laboratories, CROs, and specialist vendors.
• Oversee biosample governance and ensure operational excellence across global clinical studies.

Key Skills:

• Deep knowledge of IVDR, FDA, IVD/CDx development, assay validation, biomarker strategy, and laboratory operations.
• Experience in IVD/CDx Development & Validation.
• Expertise in IVDR & FDA Regulatory Strategy.
• Understanding of Biomarkers & Precision Medicine.
• Knowledge of Genomics / SNP-based Diagnostics.
• Proficiency in Clinical Trial Assays.
• Skills in Laboratory & Vendor Management.
• Experience in Biobanking & Sample Governance.

Salary (Rate): £170 - hourly

City: undetermined

Country: Germany

Working Arrangements: remote

IR35 Status: undetermined

Seniority Level: undetermined

Industry: Other

Detailed Description From Employer:

Interim Head of Precision Diagnostics & Biomarker Strategy (f/m/d)

Ready to shape the future of precision medicine?

For an innovative biotech environment, we are looking for an experienced freelance diagnostics expert to lead the development of a cutting-edge genetic diagnostic strategy with direct impact on clinical development and future market access.

You will own the end-to-end diagnostic roadmap-from clinical trial assay strategy through validation and regulatory readiness-while driving interactions across clinical, regulatory, data science and quality functions. Your expertise will be key in translating complex genomic algorithms into robust, clinically relevant diagnostic solutions.

The assignment requires deep knowledge of IVDR, FDA, IVD/CDx development, assay validation, biomarker strategy and laboratory operations. You will manage external laboratories, CROs and specialist vendors, oversee biosample governance, and ensure operational excellence across global clinical studies.

We are looking for a hands-on consultant who combines scientific credibility with strategic leadership, thrives in fast-moving biotech environments and knows how to turn complexity into pragmatic, actionable solutions.

Key Expertise:

• IVD/CDx Development & Validation
• IVDR & FDA Regulatory Strategy
• Biomarkers & Precision Medicine
• Genomics / SNP-based Diagnostics
• Clinical Trial Assays
• Laboratory & Vendor Management
• Biobanking & Sample Governance

Contract: Freelance / Interim Start: ASAP Duration: at least 6 months project with high strategic visibility and impact.

SThree_Germany is acting as an Employment Business in relation to this vacancy.