Clinical Affairs Director

Philips•Orange, CA

2d•Hybrid

About The Position

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. Your role: 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

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.
Strong knowledge 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.
Bachelor’s/Master’s Degree in Science or equivalent.
Excellent communicator, with an ability to influence cross-functional stakeholders utilizing your clinical expertise and knowledge of medical device regulations and research standards.

Nice To Haves

Advanced degree preferred.

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.