Director, Clinical Affairs and Medical Affairs

Argon Medical Devices Inc•Plano, TX

11h

About The Position

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.

Requirements

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

Responsibilities

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
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
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
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
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
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