- Watertown, Massachusetts, United States
- Manager
- $206K–$252K per year
- 10+ years
The Director for Companion Diagnostics will drive cross-functional alignment of biomarker operations, clinical development, regulatory & quality expectations with external device & In vitro diagnostic (IVD) partners to deliver fit-for-purpose devices that meet global regulatory requirements and support clinical decision-making.
Compensation
$206,000 - $252,000 USD This range reflects the expected base salary for this position, plus bonus, equity, and benefits as applicable.
Responsibilities
- Aligning IVD & clinical milestones with IVD quality & regulatory expectations to the timelines for the therapeutic.
- Lead oversight of device and IVD partners, ensure alignment to scopes of work, timelines, budgets, and quality expectations; manage co-development and governance.
- Define device and IVD intent, user needs, and target product profiles for CDx platforms ensuring IVD analytical and clinical performance meets intended use.
- Partner with biomarker and clinical teams to ensure IVD integration into interventional clinical studies including alignment to sample strategy and operational readiness for device and IVD submissions.
- Drive analytical validation plans and clinical validation strategies linking assay results to drug safety and efficacy.
Requirements
- Advanced degree in relevant field (e.g., molecular biology, biomedical engineering, or related) or equivalent experience
- Nice to have: rare disease
- Nice to have: oncology