Director, Clinical Affairs — Strategic Evidence & Programs

IMDx; Northern (KY); Hybrid; USD 165,000 - 175,000; Full time

Job summary

Insight Molecular Diagnostics (iMDx) is seeking a Director, Clinical Affairs to lead the integrated clinical and medical strategy across the product lifecycle for multiple platforms. This role reports to the Vice President of Medical Affairs and oversees clinical resources.

You will own end-to-end evidence generation, guide study design and execution, ensure GCP compliance, and partner with Regulatory, R&D, Product, and Commercial teams to align clinical work with business goals.

Qualifications

• Master’s degree in a scientific discipline with 8–10 years of clinical affairs experience.
• 8+ years in clinical research, evidence generation, and/or medical affairs.

Responsibilities

• Lead end-to-end clinical evidence strategy across pre-market and post-market phases.
• Direct design, execution, and oversight of clinical studies with CROs and sites.
• Ensure compliance with GCP, regulatory requirements, and internal SOPs.
• Collaborate cross-functionally with Medical Affairs, Regulatory, R&D, Product, and Commercial teams.
• Build and lead a high-performing clinical team and engage with external experts.

Skills

Strategic leadership

Clinical operations

Cross-functional collaboration

External scientific engagement

Team leadership

Regulatory & quality awareness

Education

Master’s degree in a scientific discipline

Job description

Insight Molecular Diagnostics (iMDx) is seeking a Director, Clinical Affairs to lead the integrated clinical and medical strategy across the product lifecycle for multiple platforms. This role reports to the Vice President of Medical Affairs and oversees clinical resources.

You will own end-to-end evidence generation, guide study design and execution, ensure GCP compliance, and partner with Regulatory, R&D, Product, and Commercial teams to align clinical work with business goals.