Clinical Affairs Director

About the role

The Clinical Affairs Director for Computed Tomography will drive succession planning, talent management, and innovative evidence-generation strategies that support transformative business growth. This role leads cross-functional clinical evidence programs, shapes regulatory policy and industry standards, and positions the organization as a leader in evidence-based decision-making.

Responsibilities

• Lead the translation of clinical and medical research insights into evidence-based product, regulatory, and business strategies, ensuring alignment with organizational objectives, market needs, and evolving healthcare standards.
• Drive the integration of scientific evidence to support product development, lifecycle management, and commercialization efforts.
• Direct cross-functional collaboration among Clinical Affairs, R&D, Regulatory Affairs, Medical Affairs, Marketing, and external stakeholders to ensure strategic alignment and successful execution of clinical initiatives.
• Influence decision-making across functions by balancing scientific rigor, regulatory requirements, and business priorities.
• Build and maintain strategic relationships with key external stakeholders, including clinicians, key opinion leaders (KOLs), regulatory agencies, professional societies, and healthcare organizations. Leverage stakeholder insights to inform clinical strategy, evidence generation, and product adoption initiatives.
• Oversee the development and integration of real-world evidence (RWE) strategies, ensuring high-quality data collection, analysis, and interpretation from diverse healthcare data sources. Establish governance practices that ensure compliance with data privacy, ethical standards, and regulatory expectations.
• Provide leadership for clinical studies incorporating real-world data and evidence-generation programs, ensuring robust study design, scientific validity, and regulatory acceptability. Demonstrate clinical and economic value by generating evidence that supports patient outcomes, market access, reimbursement, and long-term product success.

Requirements

Acquired 10+ years of experience in medical devices (some experience required), biotech, and pharmaceutical industries working for a sponsor directly. People leadership experience is a must. Experience in Radiology related devices or similar required.

Skills include a strong understanding of relevant standards and regulations for the medical device industry (ISO, IEC, etc.), strong experience in clinical development strategy, clinical operations, and medical affairs KOL engagement. A Bachelor’s/Master’s Degree in Science or equivalent is required, with an advanced degree preferred.

Must be able to successfully perform the following minimum physical, cognitive, and environmental job requirements with or without accommodation for this position.

An excellent communicator, with an ability to influence cross-functional stakeholders utilizing clinical expertise and knowledge of medical device regulations and research standards. Willing and able to travel up to 25%.

Qualifications

A Bachelor’s/Master’s Degree in Science or equivalent is required, with an advanced degree preferred.

Skills

• Strong understanding of relevant standards and regulations for the medical device industry (ISO, IEC, etc.)
• Strong experience in clinical development strategy, clinical operations, and medical affairs KOL engagement

Benefits

Details about our benefits can be found here.

Pay

The pay range for this position in Orange, OH is $171,000 to $273,000. The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

Schedule

This is an office-based role.