Director, Clinical Affairs and Medical Affairs

Director, Clinical Affairs and Medical Affairs Argon Medical Devices Inc - 3.2 Plano, TX Job Details Full-time 4 hours ago Qualifications Staff supervision Bachelor's degree Managing clinical research teams Biomedical regulatory compliance Medical affairs Stakeholder relationship building Stakeholder management

Full Job Description Company Overview:

: Argon Medical Devices is a global manufacturer of specialty medical products, headquartered in Plano, Texas. Argon offers a broad line of medical devices for Interventional Radiology, Vascular Surgery, Interventional Cardiology and Oncology. Argon's brand is recognized for best-in-class products that improve patient outcomes via percutaneous, image-guided procedures. Our values describe what we believe in and how we operate. These values are our moral compass which guide our decisions and define the deeply held beliefs and principles of our organizational culture. Argon Medical is a family of individuals united by a mission and culture which continue to grow stronger every day.

ARGON MEDICAL DEVICES IS NOT LEVERAGING SEARCH FIRMS

Position Overview:

: The Director of Clinical Affairs and Medical Affairs is responsible for leading the strategy, execution, and integration of clinical evidence generation and scientific engagement across the product lifecycle. This role serves as the clinical and medical lead within the organization, ensuring that clinical programs are scientifically rigorous, operationally efficient, and aligned with regulatory and commercial objectives. The position partners closely with Regulatory Affairs, R D, Quality, and Commercial leadership to translate clinical insights into product development, market adoption, and long-term evidence strategy. The Director plays a critical role in shaping clinical programs that demonstrate safety, performance, and meaningful clinical value in real-world practice.

What you will do:

: Clinical Strategy and Study Execution Leads the development and execution of clinical strategies across pre-market and post-market programs, including IDE studies, registries, and investigator-initiated studies Designs clinical protocols, defines endpoints, and ensures alignment with regulatory expectations and real-world clinical practice Oversees clinical trial execution, including site selection, CRO oversight, enrollment strategy, and data quality Maintains accountability for study timelines, budgets, and overall program delivery Drives efficient and pragmatic study designs, including outpatient and real-world settings, while maintaining scientific integrity Clinical Evidence Generation Interprets clinical data and generates scientific insights to support product development and lifecycle management Leads development of abstracts, manuscripts, podium presentations, and scientific communications in collaboration with investigators Provides clinical input into benefit-risk assessments, indication expansion strategies, and pipeline prioritization Partners cross-functionally to ensure clinical evidence supports regulatory, commercial, and market access objectives Medical Affairs and Scientific Engagement Develops and executes global medical affairs strategies focused on education, adoption, and dissemination of clinical evidence Builds and maintains relationships with key opinion leaders, investigators, and clinical partners Leads advisory boards and scientific exchange activities to inform clinical strategy and support adoption Cross-Functional Leadership Supports internal teams with clinically accurate and compliant education and training Acts as the clinical voice within new product development, ensuring early integration of clinical need, usability, and outcomes Collaborates closely with Regulatory Affairs to align clinical strategy with global regulatory requirements Partners with Quality and Risk Management to provide clinical input into risk assessments and post-market surveillance Shapes commercial and market access initiatives through evidence-based clinical strategy Organizational Leadership Leads Clinical Affairs personnel, including clinical study managers and clinical operations staff Establishes scalable processes for clinical program execution, site engagement, and data generation Manages departmental budgets, resource allocation, and external partnerships Fosters a culture of scientific rigor, accountability, and collaboration Supervisory responsibilities Provides direct leadership, coaching, and performance management for Clinical Affairs and Medical Affairs team members, including Clinical Study Managers, Clinical Operations personnel, and Medical Affairs staff Sets clear objectives, monitors performance, and conducts regular feedback and development planning to build organizational capability and bench strength Establishes organizational structure, hires and develops talent, and ensures appropriate resourcing to meet clinical and medical objectives Drives a high-performance culture focused on accountability, collaboration, and continuous improvement Ensures team adherence to company policies, quality standards, and regulatory requirements Skills for

Success:

: Bachelor's degree in life sciences, health sciences, clinical research, or related field required Minimum of 7+ years of progressive experience in the medical device industry within Clinical Affairs, Medical Affairs, or related functions Minimum of 5+ years of leadership experience managing teams and/or complex clinical programs Demonstrated experience leading clinical studies, including pre-market and post-market programs Experience working within FDA and/or EU MDR regulatory environments Strong clinical study design and execution capabilities with emphasis on real-world applicability Ability to interpret and translate clinical data into strategic and operational decisions Experience engaging physicians and building key opinion leader networks Operational discipline in managing multi-site clinical programs and external partners Strong communication and stakeholder management skills 40% travel