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; partner with clinical teams on biomarker selection, assay validation, and biological sample collection/handling.
- Manage project plans, budgets, and timelines; ensure on-time, high-quality delivery of diagnostic milestones via cross-functional collaboration.
- Partner with regulatory/quality teams to meet diagnostic expectations and support diagnostic regulatory submissions.
- Engage external partners (diagnostic companies, clinical labs, technology vendors) to accelerate assay development and access patient samples.
- Provide frequent status updates/reports on diagnostic deliverables; share best practices and drive process improvements.

Basic Qualifications:
- Bachelor’s degree in life sciences/molecular diagnostics/clinical lab science (advanced degree preferred).
- 8+ years in diagnostic development/biomarker strategy/clinical assay development, including 2–3 years in oncology diagnostic development.
- Experience integrating diagnostics into clinical trial design (efficacy endpoints, biomarker testing, data/specimen management).
- Knowledge of diagnostic/companion diagnostic regulatory and quality systems (FDA/EU medical device regulations, QSR, GMP, ISO 13485).
- Ability to develop diagnostic protocols and analysis plans; manage cross-functional matrix projects (timelines/budgets/stakeholders).

Preferred Qualifications:
- MS/PhD/MD; experience with NGS, PCR, immunohistochemistry or other oncology biomarker assays.
- Experience with diagnostic regulatory submissions/interactions; laboratory accreditation/clinical lab operations.
- Experience enabling diagnostic launch and market adoption.

Application:
- Submit CV and a brief cover letter.

Benefits (explicitly listed): health care/insurance, retirement, paid holidays, vacation, paid caregiver/parental and medical leave.