Senior Director, Clinical Strategy & Execution

iMDx; United States; On-site; USD 180,000 - 250,000; Full time

Job summary

Insight Molecular Diagnostics (iMDx) is seeking a Director of Clinical Affairs to define and drive the integrated clinical and medical strategy across the product lifecycle for one or more therapeutic areas or platforms.

The role provides end-to-end accountability for clinical evidence generation and external scientific engagement, reporting to the Vice President, Medical Affairs, and managing clinical resources within Medical Affairs.

Qualifications

• Master’s degree or equivalent in a scientific discipline; 8–10 years in clinical affairs roles.
• 8+ years in clinical research/evidence generation or medical affairs.
• Ability to build and execute clinical programs in a startup or high-growth environment.
• Strong communication and cross-functional influence with senior leadership.

Responsibilities

• Own end-to-end clinical evidence strategy across pre-market and post-market phases.
• Lead design, execution, and oversight of clinical studies, including CRO/vendor management.
• Ensure compliance with GCP, regulatory requirements, and internal SOPs.
• Develop and scale clinical infrastructure, SOPs, and governance frameworks.
• Build relationships with investigators, KOLs, and regulators; contribute to publications.

Skills

Strategic leadership

Cross-functional collaboration

Clinical studies leadership

Regulatory & GCP knowledge

Team management

External stakeholder engagement

Education

Master’s degree in a scientific discipline

Job description

Insight Molecular Diagnostics (iMDx) is seeking a Director of Clinical Affairs to define and drive the integrated clinical and medical strategy across the product lifecycle for one or more therapeutic areas or platforms.

The role provides end-to-end accountability for clinical evidence generation and external scientific engagement, reporting to the Vice President, Medical Affairs, and managing clinical resources within Medical Affairs.