Are you an experienced clinical research leader with a passion for driving innovation in medical device trials? We are seeking a Director of Clinical Trials (Medical Device) in Miami, FL, to oversee and manage end-to-end clinical trial operations, ensuring compliance, efficiency, and the highest ethical standards. This executive role is ideal for a strategic professional with deep expertise in clinical study design, regulatory compliance, and cross-functional team leadership.
As the Director of Clinical Trials (Medical Device) in Miami, FL, you will play a pivotal role in advancing cutting-edge medical device solutions by leading clinical research strategies, securing FDA approvals, and optimizing trial processes. If you are a results-driven leader with a track record of successfully executing large-scale clinical trials and regulatory submissions, this opportunity offers the perfect platform to shape the future of healthcare innovations.
About This Role
The Director of Clinical Trials (Medical Device) in Miami, FL, will be responsible for overseeing the entire lifecycle of clinical studies, from protocol development and site selection to data analysis and regulatory compliance. This position requires a visionary leader who can design and implement clinical strategies that support product development and commercialization while ensuring patient safety and adherence to FDA, ISO, and GCP guidelines.
In this role, you will collaborate with key stakeholders, including regulatory bodies, investigators, CROs, and cross-functional teams, to drive the success of clinical research programs. The Director of Clinical Trials (Medical Device) in Miami, FL, must possess strong leadership skills, the ability to navigate complex regulatory landscapes, and the expertise to optimize clinical trial efficiencies. This is a unique opportunity to lead innovative clinical programs that contribute to groundbreaking medical advancements.
Key Responsibilities – Director of Clinical Trials (Medical Device) in Miami, FL
1. Oversee Clinical Trial Strategy and Execution
- Develop and implement clinical trial strategies aligned with company objectives.
- Ensure seamless execution of clinical trials from study initiation to final reporting.
- Continuously evaluate and optimize trial processes for efficiency and compliance.
2. Ensure Regulatory Compliance and Ethical Standards
- Maintain adherence to FDA, ISO, GCP, and other international regulatory requirements.
- Oversee regulatory submissions, including IDE, PMA, and 510(k) applications.
- Collaborate with legal and compliance teams to mitigate regulatory risks.
3. Manage Site Selection and Investigator Relations
- Identify and select clinical trial sites with proven expertise in medical device studies.
- Establish and maintain strong relationships with investigators and key opinion leaders.
- Conduct site audits to ensure adherence to protocols and regulatory standards.
4. Lead Cross-Functional Teams and CRO Partnerships
- Oversee internal clinical teams, CROs, and external vendors to ensure trial success.
- Provide leadership in project management, budget allocation, and resource planning.
- Monitor CRO performance and ensure contract compliance.
5. Data Management and Clinical Outcomes Analysis
- Ensure accurate data collection, validation, and statistical analysis for clinical trials.
- Collaborate with biostatisticians to interpret clinical outcomes and patient safety data.
- Oversee the development of clinical study reports and regulatory documentation.
6. Drive Patient Recruitment and Retention Strategies
- Develop patient recruitment strategies to enhance trial participation and diversity.
- Implement retention programs to minimize dropout rates and ensure study integrity.
- Work with marketing and patient advocacy groups to raise awareness of clinical studies.
7. Budget and Timeline Oversight for Clinical Trials
- Develop and manage clinical trial budgets, ensuring cost-effectiveness and efficiency.
- Track trial timelines and milestones to ensure projects are delivered on schedule.
- Identify and resolve financial or operational challenges affecting trial execution.
8. Continuous Improvement and Innovation in Clinical Trials
- Stay updated on emerging trends and innovations in medical device clinical research.
- Implement best practices and cutting-edge methodologies to enhance trial efficiency.
- Participate in scientific conferences and industry forums to represent the company.
What The Client is Looking For in You
To excel as the Director of Clinical Trials (Medical Device) in Miami, FL, you should bring a combination of leadership, clinical research expertise, and regulatory knowledge. The ideal candidate will possess:
- Extensive Experience in Clinical Trials for Medical Devices – A deep understanding of clinical trial design, regulatory requirements, and medical device development. Experience managing multi-site, global trials is a plus.
- Proven Leadership in Clinical Operations – A strong track record of leading cross-functional teams, CROs, and clinical investigators to drive successful trial outcomes.
- Regulatory and Compliance Knowledge – Expertise in FDA, ISO 14155, GCP, and international regulatory frameworks governing medical device clinical trials.
- Strategic Thinking and Problem-Solving Abilities – The ability to anticipate challenges, optimize trial processes, and drive efficiency in clinical research.
- Strong Data-Driven Decision-Making Skills – Experience with clinical data management, statistical analysis, and clinical study reporting to support regulatory submissions.
- Exceptional Communication and Stakeholder Management – Ability to collaborate effectively with internal teams, investigators, regulatory agencies, and executive leadership.
- Budget and Timeline Management Expertise – Proven ability to manage multi-million-dollar clinical trial budgets and ensure projects are completed within scope and deadlines.
- Passion for Medical Innovation – A commitment to advancing medical technology and improving patient outcomes through rigorous clinical research.
Why This Opportunity Stands Out
This role offers a unique opportunity to shape the future of medical device clinical research. As the Director of Clinical Trials (Medical Device) in Miami, FL, you will:
- Lead Cutting-Edge Medical Device Trials – Drive clinical studies that bring life-saving medical technologies to market and improve patient care.
- Work with an Innovative and Growing Organization – Join a dynamic company at the forefront of medical device innovation, with a strong pipeline of groundbreaking products.
- High-Impact Executive Role – Play a strategic role in guiding clinical research, securing regulatory approvals, and supporting product commercialization.
- Competitive Compensation and Benefits – Enjoy a lucrative salary, performance-based incentives, and comprehensive benefits, including executive perks.
- Global Influence on Healthcare Advancements – Lead clinical programs with international reach, expanding access to innovative medical technologies worldwide.
- Collaborate with Industry Experts and Key Opinion Leaders – Work alongside top clinical researchers, regulatory professionals, and healthcare leaders.
- Professional Growth and Career Advancement – Take on a leadership role with opportunities for future executive advancement within the company.
FAQs About the Role
Q: What industries should I have experience in?
A: You should have extensive experience in the medical device industry, specifically in clinical research, clinical trial management, and regulatory affairs.
Q: Is relocation required for this position?
A: The role is based in Miami, FL. Candidates should be open to relocating or already reside in the area.
Q: What qualifications and experience are required?
A: Candidates should have a master’s or doctoral degree in life sciences, clinical research, or a related field. A minimum of 10+ years of clinical trial leadership experience is required.
Q: What is the reporting structure for this role?
A: The Director of Clinical Trials (Medical Device) in Miami, FL will report directly to the VP of Clinical Affairs and collaborate closely with R&D, regulatory, and commercial teams.
Q: What is the expected travel requirement?
A: This role requires periodic travel to clinical trial sites, industry conferences, and regulatory meetings, both domestically and internationally.
Q: What kind of leadership style is expected?
A: We are looking for a strategic, data-driven leader who can inspire teams, foster collaboration, and drive high-performance clinical research programs.
Q: How does this role contribute to the company’s success?
A: The Director of Clinical Trials (Medical Device) in Miami, FL plays a crucial role in ensuring the success of clinical studies, regulatory approvals, and market entry for innovative medical devices.
Q: What is the timeline for hiring and onboarding?
A: The company aims to complete the hiring process within the next 60–90 days, with a structured onboarding plan that includes deep dives into ongoing clinical programs and alignment on strategic goals.
What Remuneration Can You Expect from This Job?
As the Director of Clinical Trials (Medical Device) in Miami, FL, you can expect a highly competitive compensation package that reflects the strategic importance of your role. The base salary for this position typically ranges between $180,000 – $250,000 per year, depending on experience, expertise in clinical research, and leadership capabilities.
In addition to a competitive base salary, this position offers performance-based bonuses and long-term incentives linked to clinical trial success, regulatory approvals, and product commercialization milestones. Equity options or stock grants may be available, providing a unique opportunity to share in the company’s long-term growth and success.
The benefits package includes comprehensive healthcare coverage (medical, dental, and vision), a 401(k) retirement plan with company matching, generous paid time off, and executive-level perks such as travel allowances and participation in industry conferences. Additional benefits may include relocation assistance, professional development funding, and flexible work arrangements.
This role offers not just financial rewards but also an opportunity to lead cutting-edge clinical trials, play a key role in regulatory strategy, and drive medical device innovations that transform healthcare.
How to Apply for This Director of Clinical Trials (Medical Device) Position in Miami, FL
If you are a seasoned clinical research professional with a strong background in medical device trials and regulatory strategy, we invite you to apply for the Director of Clinical Trials (Medical Device) in Miami, FL. This is an exceptional opportunity to lead groundbreaking clinical studies and contribute to the development of life-changing medical technologies.
To apply, please submit your resume and a cover letter outlining your experience in clinical trial design, regulatory compliance, and leadership in medical device research.
This role provides a unique chance to work with a top-tier medical device company, driving clinical programs that shape the future of healthcare. Apply today to take the next step in your career as a Director of Clinical Trials (Medical Device) in Miami, FL!
For more information or to explore similar opportunities, visit our Medical Device Recruiters Page.
Tags:
Director of Clinical Trials | Medical Device Research | Clinical Affairs Leadership | Regulatory Compliance | Clinical Trial Management | Clinical Operations
