Director / Senior Director, Precision Diagnostics - Oncology

Responsibilities:
- Develop and execute precision diagnostics strategy for oncology programs across multiple assets/therapeutic areas.
- Define trial diagnostic requirements; with clinical teams implement biomarker selection, assay validation, and biological sample collection/handling strategy.
- Oversee project plans, budgets, and timelines to deliver diagnostic milestones with cross-functional teams.
- Partner with regulatory/quality teams to meet diagnostic regulatory expectations and support diagnostic regulatory submissions.
- Engage external partners (diagnostic companies, clinical labs, technology vendors) to accelerate assay development and patient sample access.
- Provide frequent status updates/reports and share learnings/best practices; support process improvement initiatives.

Qualifications:
- BS in life sciences, molecular diagnostics, clinical lab science, or related field (advanced degree preferred).
- 8+ years diagnostic/biomarker strategy and/or clinical assay development; 2–3 years direct oncology diagnostic development.
- Experience integrating diagnostics into clinical trial design (efficacy endpoints, biomarker testing, data management, specimen management/operations).
- Knowledge of diagnostic/companion diagnostic regulatory and quality systems (FDA/EU medical device regulations, QSR, GMP, ISO 13485) and diagnostic protocol/analysis plan development.
- Manage cross-functional projects in matrix; strong stakeholder management and collaboration.

Preferred:
- MS/PhD/MD; experience with NGS/PCR/IHC oncology biomarker assays; regulatory submission experience; lab accreditation/clinical lab ops; partnering with commercial teams for diagnostic launch.

Benefits (explicitly stated): annual bonus; share-based long-term incentive; health/insurance, retirement, paid holidays/vacation, paid caregiver/parental and medical leave.

How to apply: Submit CV and a brief cover letter describing relevant experience and why the role matters.