[Hiring] Director of Clinical Affairs @Insight Molecular Diagnostics Inc

Role Description

At Insight Molecular Diagnostics (iMDx), our mission is to democratize access to molecular diagnostic testing. Join us and be part of a team that’s redefining what’s possible in healthcare.

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Qualifications

• Master’s degree or equivalent in a scientific discipline with a minimum of 8-10 years of experience in progressively responsible clinical affairs roles in the medtech, biotech industries or related field required.
• 3-5 years of management experience.
• 8+ years in clinical research, evidence generation, and/or medical affairs experience is required.

Requirements

• 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 attitude.
• 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.

Benefits

• Competitive salary and performance-based bonuses.
• Comprehensive health benefits.
• Opportunities for professional development and growth.
• Flexible work environment.

Physical Demands

• Employee is required to stand; walk, sit, bend, reach and use hands to finger, handle or feel.
• May occasionally lift and/or move 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.
• Travel about 40% of the time.