Director of Clinical Research (Finance)

Requisition ID: 62715 Title: Director of Clinical Research Division: Arthrex, Inc. (US01) Location: Naples, FL

Arthrex is a global medical device company and a leader in new product development and clinical research. Arthrex is actively searching for a Director of Clinical Research to lead our initiatives in clinical studies and support new product development. The successful candidate will manage and oversee the Clinical Research team, ensuring compliance with regulatory requirements and driving clinical validation for our innovative orthopedic solutions. Excellent leadership, interpersonal, and presentation skills, along with ten years or more of related experience and a master's degree are essential for this position. Join our talented team at a global medical device company dedicated to enhancing patient care through cutting-edge technology.

Main Objective:

Responsible for leading the Clinical Research team in the development and execution of clinical studies, ensuring compliance with regulatory requirements, and supporting new product development through clinical validation. Reviews, approves, and executes in-house and customer-proposed research studies. Assists New Product Development Teams in the design and testing of new products. Researches competitive and new product ideas and presents them to Engineering, Product Management, and Leadership.

Essential Duties And Responsibilities:

• Manages the Clinical Research Department's work activities to ensure timely and efficient flow of services and projects.
• Maintains a leading-edge understanding of the orthopedic industry, customers, and competitors to identify new opportunities for clinical research.
• Oversees the design, execution, and management of clinical studies, including protocol development, site selection, and data analysis.
• Ensures compliance with regulatory requirements and ethical standards in all clinical research activities.
• Collaborates with New Product Development Teams to provide clinical insights and support the design and testing of new products.
• Develops and oversees budgets and timelines for clinical studies.
• Contributes to the grants and external-study funding processes and decisions.
• Provides support to Quality Assurance, Regulatory Affairs, and Product Management departments as needed.
• Reports progress and status of clinical projects to the Vice President of Strategic Development and other senior leaders as necessary.
• Hires, develops, and retains the best talent for the Clinical Research team. Actively provides coaching and career development assistance to team members. Develops future leaders through effective selection and development activities.

Education And Experience

• Master's degree required. PhD Degree preferred.
• Minimum of 10 years of experience in clinical research, with at least 5 years in a leadership role.
• Extensive knowledge of regulatory requirements and ethical standards in clinical research.
• Proven track record in the design, execution, and management of clinical studies.
• Strong understanding of the orthopedic industry, including current trends and competitive landscape.

Knowledge and Skill Requirements/Specialized Courses and/or Training:

• Working knowledge of clinical research methodologies and regulatory requirements.
• Proficiency in designing and managing clinical studies.
• Strong understanding of orthopedic surgery principles, theories, and products.
• Ability to assess the value of new product ideas based on clinical and financial merits.

Machine, Tools, and/or Equipment Skills:

Microsoft Office, PCs, 3D-CAD program, and office equipment.

Arthrex Benefits

• Medical, Dental and Vision Insurance
• Company-Provided Life Insurance
• Voluntary Life Insurance
• Flexible Spending Account (FSA)
• Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
• Matching 401(k) Retirement Plan
• Annual Bonus
• Wellness Incentive Program
• Free Onsite Medical Clinics
• Free Onsite Lunch
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Parental Leave
• Paid Time Off
• Volunteer PTO
• Employee Assistance Provider (EAP)
• Eligible for discretionary Long Term Incentive program

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.