Director, Clinical Affairs

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

AtInsight 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.

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.

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.
• 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

• Education and Experience:
  • Master’s degree or equivalent in a scientific discipline with a minimum of 8-10 year’s experience in progressively responsible clinical affairs roles in the medtech, biotech industries or related field required. And 3-5 years of management experience.
  • 8+ years in clinical research, evidence generation, and/or medical affairs experience is required.
• Skills and Competencies:
  • Ability to build and execute clinical programs in a start-up or high-growth environment.
  • Ability to develop, lead a team of professionals and provide constructive feedback in a professional and timely manner.
  • Solid knowledge and background of clinical trials, study design.
  • Strong understanding of trial planning and design, operationalization, and regulatory expectations.
  • Strategic thinker with strong execution capability and a hands‑on leadership style.
  • Demonstrated ability to influence cross-functional stakeholders and operate in ambiguity.
  • Strong external engagement experience with investigators, KOLs, and regulators.
  • Proven ability to manage competing priorities across multiple projects in a fast-paced, dynamic environment.
  • Familiarity with regulated quality systems (CLIA, CAP, ISO 13485, Design Control, GMP, and 21 CFR 820). Experience supporting FDA or Notified Body audits is preferred.
  • Exceptional written and verbal communication skills; ability to collaborate cross‑functionally with senior leadership and scientific staff.
  • Able to travel 40% of the time.
• You have a “do what it takes – no job is too small” team player and a positive attitude with a willingness to wear other hats and step in to perform and support other roles when needed.
• A team player who is curious, adaptable, and willing to learn new techniques or concepts.
• Your organizational skills, attention to detail, and ability to multi‑task are excellent.
• A proactive problem‑solver who takes ownership of assigned tasks.
• You like building effective internal relationships including with team members, clients, vendors, suppliers, and team members.

Physical Demands

• Employee is required to stand; walk, sit, bend, reach and use hands to finger, handle or feel.
• May occasionally lift and/or more up to 25 pounds.
• Able to talk or hear.
• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for at least 50% of a typical working day.