Associate Director – Precision Medicine, Clinical Diagnostics

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

📋 Description

• Direct the companion diagnostic strategy and development from initial biomarker feasibility through to clinical validation, regulatory submission, and market launch.

• Convert biomarker and mechanism-of-action data into diagnostic target product profiles and determine assay intent across NGS, PCR, immunohistochemistry, and immunoassay platforms.

• Collaborate with translational and clinical teams on biomarker strategies for patient selection, stratification, and enrichment, including sample strategy and specimen logistics.

• Oversee analytical and clinical validation planning, which includes accuracy, precision, sensitivity/specificity, limit of detection, and reproducibility.

• Establish global CDx strategy and synchronize diagnostic milestones with clinical and regulatory timelines.

• Choose and manage IVD development partners while overseeing co-development scope, timelines, and quality expectations.

• Assist with global regulatory strategy and submissions, including FDA PMA/supplement, EU IVDR, and PMDA, in collaboration with IVD Regulatory.

• Ensure adherence to ISO 13485, ISO 14971, CLSI, IVDR, and GCP-alignment standards.

• Lead cross-functional working groups and convert scientific rationale into program plans and governance reporting.

• Aid in design transfer, manufacturing readiness, and launch preparation in conjunction with commercial and medical affairs.

⛳️ Requirements

• PhD or advanced degree in molecular biology, pathology, biomedical engineering, or a related field in translational/biomedical science.

• Over 8 years of experience in diagnostics or translational research.

• At least 4 years of experience leading biomarker-driven CDx or IVD programs that connect bench discovery with clinical application.

• Proven history of translating biomarker science into validated assays that support drug approvals.

• Familiarity with global CDx regulatory pathways, including FDA CDRH, EU IVDR, and PMDA.

• Capability to convert complex scientific and clinical data for cross-functional and executive audiences.

• Experience managing external partners and multi-workstream programs in QMS/GxP-adjacent environments.

🏝️ Benefits

• Annual bonuses or other incentive plans.

• Equity awards.

• Pension or retirement benefits.

• 401(k) company match.

• Health and wellness programs.

• Access to fitness centers.

• Comprehensive medical, dental, vision, life, and disability insurance benefits.

• Paid time off.

• Family support benefits.

• Reasonable accommodation during the recruitment process for applicants with known disabilities or chronic illnesses.