Director, Clinical Strategy & Trials

Moximed; United States; On-site; USD 180,000 - 240,000; Full time

Job summary

Moximed seeks a Director of Clinical Affairs to design and execute clinical research strategies aligned with commercial goals. You will lead post-market trials, ensure regulatory compliance (FDA/EU MDR), and manage cross-functional programs across R&D, Regulatory, Medical Affairs, and Quality to support device development and market success.

The role requires oversight of protocol development, budgeting, site management, vendor relationships, and data management to maximize commercial potential

Qualifications

• Minimum 8–10 years of progressive experience in clinical affairs within the medical device industry.
• Experience with Class II/III implantable devices; orthopedic medical device experience preferred.
• Excellent written and verbal communication/presentation skills.
• Strong cross-functional leadership and communication capabilities.
• Entrepreneurial, collaborative, strategic thinker with strong project management.

Responsibilities

• Manage clinical evaluations to support regulatory filings or marketing initiatives.
• Develop budgets for clinical trials and track costs for operations.
• Lead day-to-day execution of clinical trials, including site selection and monitoring.
• Oversee multi-functional clinical program development with R&D, Regulatory, Marketing, and Data Management.
• Coordinate study protocols, case report forms, and data management for sponsor-initiated trials.
• Oversee post-market clinical studies and regulatory submissions with FDA/EU authorities.
• Plan, implement, and execute training for internal and external staff participating in trials.
• Ensure GCP compliance and maintain Clinical Trial Master Files.

Skills

Cross-functional leadership

Communication

Project management

Team building

Education

Bachelor’s degree (scientific, nursing, or engineering)

Advanced degrees (MS/PhD/MD) preferred

Job description

Moximed seeks a Director of Clinical Affairs to design and execute clinical research strategies aligned with commercial goals. You will lead post-market trials, ensure regulatory compliance (FDA/EU MDR), and manage cross-functional programs across R&D, Regulatory, Medical Affairs, and Quality to support device development and market success.

The role requires oversight of protocol development, budgeting, site management, vendor relationships, and data management to maximize commercial potential