Associate Director, Precision Medicine (Clinical Diagnostics)

Responsibilities:
- Translate biomarker and mechanism-of-action data into diagnostic target product profiles (TPPs), defining assay intent across platforms (NGS, PCR, immunohistochemistry, immunoassays).
- Partner with translational and clinical teams to design biomarker strategies for patient selection, stratification, and enrichment, including sample strategy and specimen logistics.
- Lead analytical and clinical validation planning (accuracy, precision, sensitivity/specificity, limit of detection, reproducibility) linking assay performance to clinical safety and efficacy endpoints.
- Set global CDx strategy for assigned programs and align diagnostic milestones with clinical and regulatory timelines.
- Select and oversee IVD development partners; manage co-development scope, timelines, and quality expectations.
- Support global regulatory strategy and submissions (FDA PMA/supplement, EU IVDR, PMDA), including labeling alignment.
- Ensure compliance with ISO 13485, ISO 14971, CLSI, IVDR, and GCP alignment.
- Lead cross-functional working groups and provide governance reporting.
- Support design transfer, manufacturing readiness, and launch preparation with commercial and medical affairs.

Qualifications/Skills:
- PhD or advanced degree in molecular biology, pathology, biomedical engineering, or related translational/biomedical science.
- 8+ years in diagnostics or translational research; 4+ years leading biomarker-driven CDx/IVD programs.
- Track record translating biomarker science into validated assays supporting drug approvals.
- Working knowledge of FDA CDRH, EU IVDR, and PMDA CDx regulatory pathways.
- Ability to translate complex scientific/clinical data for cross-functional and executive audiences.
- Experience managing external partners and multi-workstream programs under QMS/GxP-adjacent conditions.

Application instructions:
- “Apply now”.