Director, Clinical Affairs

At Insight Molecular Diagnostics (iMDx), our mission is to democratize access to molecular diagnostic testing. At our heart, we are a science-driven organization focused on giving clinicians and researchers the diagnostic tools they need to help improve patient outcomes.

Join us and be part of a team that’s redefining what’s possible in healthcare.

1. Strategic Clinical Leadership

Develops and executes a comprehensive clinical evidence strategy aligned with organizational objectives. Anticipates future clinical, regulatory, and market needs while translating scientific insights into actionable business strategies.

2. Clinical Operations & Execution Excellence

Leads the successful planning, execution, and oversight of clinical studies, ensuring projects are delivered on time, within budget, and in compliance with GCP, regulatory requirements, and quality standards.

3. Cross-Functional Collaboration & Influence

Builds strong partnerships across Medical Affairs, Regulatory, R&D, Product, Commercial, and external stakeholders. Effectively influences decision-making and aligns diverse teams around shared clinical and business objectives.

4. People Leadership & Talent Development

Builds, develops, and inspires high-performing teams by setting clear expectations, fostering accountability, providing coaching, and creating an environment of scientific excellence, collaboration, and continuous growth.

5. External Scientific Engagement

Establishes and maintains trusted relationships with investigators, key opinion leaders (KOLs), regulatory agencies, and scientific organizations. Represents the company with credibility and leverages external insights to strengthen clinical strategy.

6. Results Orientation & Agility

Demonstrates a hands-on, solution-oriented approach in a fast-paced environment by effectively prioritizing competing demands, navigating ambiguity, and driving execution while maintaining high standards of quality and integrity.

Professional Experience

The Director of Clinical Affairs is a leader responsible for defining and driving the integrated clinical and medical strategy across the product lifecycle for one or more therapeutic areas or platforms. This role provides end-to-end accountability for clinical evidence generation and external scientific engagement, ensuring alignment with corporate, commercial, and cross-functional objectives.

The Director serves as a key strategic advisor to senior leadership and represents the organization to external stakeholders. This role reports to the Vice President, Medical Affairs and manages Clinical resources, operating as a distinct clinical evidence function within Medical Affairs.

Your day-to-day: 

Clinical & Evidence Strategy Ownership

• Own and define the end-to-end clinical evidence strategy across pre-market and post-market phases.
• Develop integrated evidence generation plans aligned with regulatory, product development, and commercialization objectives.
• Identify evidence gaps and prioritize studies to support approvals, adoption, and differentiation.
• Translate clinical insights into actionable recommendations to inform product and business strategy.

Clinical Study Leadership & Execution

• Lead the design, execution, and oversight of clinical studies, including protocol development and endpoint selection.
• Direct end-to-end study operations, including: 
  • CRO/vendor selection and management
  • Site and investigator engagement
  • Data collection, monitoring, analysis, and reporting
• Oversee development of clinical study reports (CSRs) and publication plans.
• Ensure compliance with GCP, regulatory requirements, and internal SOPs.
• Maintain accountability for timelines, budgets, quality, and study outcomes.

Clinical Infrastructure & Capability Building (Startup Focus)

• Build and scale clinical research infrastructure, processes, and systems.
• Establish fit-for-purpose SOPs, workflows, and governance frameworks.
• Develop efficient operating models leveraging internal teams and external partners.
• Ensure organizational readiness for regulatory submissions, inspections, and audits.

External Scientific Engagement

• Develop and maintain relationships with investigators, KOLs, and clinical experts.
• Represent the company in regulatory interactions, investigator meetings, and advisory boards.
• Generate and synthesize insights from external stakeholders, literature, and congresses to inform strategy.
• Contribute to shaping the external scientific and clinical landscape through credible engagement.

People Leadership

• Lead and develop a high-performing clinical team, including consultants, and vendor partners.
• Coach and guide the clinical team in consistently achieving their goals in support of the overall company goals.
• Set clear goals, priorities, drive accountability, and foster a culture of scientific excellence and agility.
• Conduct performance evaluations in accordance with the company’s policies.

Cross-Functional Leadership

• Act as a core partner and work collaboratively with Commercial, Quality & Regulatory, R&D, Product, Marketing and other key functional teams within the organization.
• Ensure clinical strategy is tightly aligned with regulatory and business priorities.
• Provide clinical input into product development, labeling, positioning, and market access discussions.
• Support regulatory submissions with robust and defensible clinical evidence.

Selective Medical Affairs Integration

• Collaborate with Medical Affairs on: 
  • Medical insights generation
  • Scientific communications and publications
  • Medical education and congress operations (as appropriate)
• Provide scientific oversight of clinical content to ensure accuracy, integrity, and compliance.
• Maintain clear separation of clinical evidence generation from promotional activities.

Compliance & Quality

• Ensure all clinical activities adhere to GCP, regulatory requirements, and internal policies.
• Oversee adverse event reporting and safety monitoring within clinical studies.
• Support quality systems and inspection readiness.

What you bring to the table