Senior Director, Clinical Strategy & Evidence

Insight Molecular Diagnostics Inc; United States; Remote; USD 165,000 - 175,000; Full time

Job summary

Insight Molecular Diagnostics (iMDx) is seeking a Director of Clinical Affairs to lead the integrated clinical and medical strategy across product lifecycles. You will own evidence generation, drive external engagement with investigators, and manage a high-performing clinical team in a fast-paced environment.

The role reports to senior leadership and requires building partnerships across Medical Affairs, Regulatory, R&D, Product, and Commercial. Travel up to 40% is expected.

Qualifications

• Master's degree or equivalent in a scientific discipline and 8-10 years in clinical affairs.
• 3-5 years of management experience in medtech/biotech settings.
• Strong ability to influence cross-functional stakeholders.

Responsibilities

• Own end-to-end clinical evidence strategy for pre- and post-market phases.
• Lead design, execution, and oversight of clinical studies with vendors.
• Build clinical operations infrastructure and governance.
• Manage external scientific engagement with investigators, KOLs, and regulators.
• Ensure compliance with GCP and regulatory requirements.

Skills

Clinical program leadership

Regulatory understanding

Clinical study design

Team leadership

Cross-functional collaboration

External engagement

Strategic thinking

Adaptability

Education

Master's degree or equivalent in a scientific discipline

8-10 years in clinical affairs

3-5 years management experience

Job description

Insight Molecular Diagnostics (iMDx) is seeking a Director of Clinical Affairs to lead the integrated clinical and medical strategy across product lifecycles. You will own evidence generation, drive external engagement with investigators, and manage a high-performing clinical team in a fast-paced environment.

The role reports to senior leadership and requires building partnerships across Medical Affairs, Regulatory, R&D, Product, and Commercial. Travel up to 40% is expected.