Head of Clinical Affairs – St. Petersburg, FL | Diagnostic Devices

We are seeking a dynamic and experienced Head of Clinical Affairs to join a leading Diagnostic Devices company in St. Petersburg, FL. This key leadership role presents an exciting opportunity for a visionary professional with a proven track record in clinical operations to oversee and advance the company’s clinical affairs strategy. If you are passionate about transforming the healthcare landscape through cutting-edge diagnostic technology, this role is perfect for you.

Drive Clinical Excellence and Innovation in Diagnostics

As the Head of Clinical Affairs, you will play a pivotal role in shaping the future of diagnostic devices. This role involves overseeing clinical trials, regulatory strategies, and ensuring compliance with all medical and regulatory standards. The ideal candidate will bring strong leadership, in-depth knowledge of clinical affairs, and a passion for advancing diagnostic technology to improve patient outcomes. If you thrive in a collaborative environment and have a deep understanding of the clinical trial lifecycle, this opportunity is your chance to lead a transformative team in a growing field.

Key Responsibilities of the Head of Clinical Affairs – Diagnostic Devices

Clinical Strategy & Leadership:
Develop and execute a comprehensive clinical affairs strategy that aligns with the company’s business objectives and regulatory requirements. Lead the clinical team in overseeing clinical trials, ensuring scientific rigor, ethical standards, and compliance with all relevant medical and regulatory guidelines. Provide thought leadership to drive the adoption of innovative diagnostic devices in clinical settings.

Regulatory & Compliance Oversight:
Ensure adherence to all regulatory requirements (FDA, ISO, CE, etc.) for clinical trials and product development processes. Work closely with regulatory agencies to ensure successful submissions and approvals, maintaining compliance with local and global healthcare regulations. Lead the preparation and management of regulatory documents and submissions to support product commercialization.

Clinical Trial Management:
Oversee the design, execution, and monitoring of clinical trials, ensuring they are conducted efficiently, within budget, and in compliance with regulatory guidelines. Ensure accurate data collection, reporting, and analysis while maintaining a focus on patient safety and trial integrity. Collaborate with cross-functional teams to manage trial timelines, resources, and deliverables.

Collaboration with R&D and Product Development:
Partner with research and development teams to provide clinical insights during the product development lifecycle. Ensure that clinical input is integrated into device design, testing, and preclinical validation. Support the transition from development to commercial launch, ensuring a smooth regulatory and clinical pathway.

Team Leadership & Development:
Lead, mentor, and develop the clinical affairs team, promoting a culture of collaboration, accountability, and continuous learning. Foster an environment that encourages innovation, professional growth, and high performance. Ensure the team is aligned with company goals and objectives while supporting their career advancement.

Stakeholder & Investor Relations:
Build strong relationships with internal and external stakeholders, including executives, investors, clinical partners, and regulatory bodies. Provide regular updates on clinical trials, regulatory progress, and product development milestones. Ensure transparent communication and data-driven insights to secure ongoing support and funding.

Clinical Data Management & Reporting:
Oversee the collection, analysis, and reporting of clinical trial data. Ensure high standards of data integrity and accuracy. Collaborate with the data management team to ensure proper handling of clinical data, generating reports that inform clinical and business decisions.

Market Access & Product Launch Support:
Work with commercial teams to support market access and product launch strategies. Provide clinical expertise to help define reimbursement strategies, market entry, and product positioning. Ensure that clinical evidence supports the value proposition for healthcare providers and patients.

Risk Management & Safety Monitoring:
Monitor the safety and efficacy of diagnostic devices through post-market surveillance, ensuring that adverse events are reported, investigated, and mitigated as needed. Implement risk management processes to ensure patient safety and device performance throughout the clinical lifecycle.

Budget & Resource Management:
Manage the clinical affairs budget, ensuring that resources are allocated efficiently to support clinical trial activities. Oversee vendor selection, contract negotiation, and third-party relationships to ensure cost-effective trial management.

What the Client is Looking for in You

As the Head of Clinical Affairs for a leading diagnostic devices company, the client is looking for a highly skilled and experienced clinical leader with a strong track record in managing clinical affairs, ensuring regulatory compliance, and driving innovation in the healthcare and medical device industry. You should be a strategic thinker with excellent leadership capabilities and a passion for improving patient outcomes through groundbreaking diagnostic technologies.

Proven Leadership in Clinical Affairs

The client seeks a seasoned clinical leader with extensive experience in clinical trials, regulatory processes, and managing clinical affairs teams. You should have a proven ability to lead cross-functional teams in clinical settings, ensuring that trials are executed efficiently and in compliance with industry regulations. Experience in the diagnostic device industry is highly valued, and a demonstrated ability to manage complex clinical projects will be key to your success in this role.

Strategic Vision and Regulatory Expertise

As the Head of Clinical Affairs, you must have the ability to craft and execute clinical strategies that align with the company’s overall goals. The ideal candidate will be well-versed in regulatory affairs, with experience in obtaining approvals from regulatory bodies such as the FDA and EMA. You should be able to anticipate regulatory changes, adapt strategies accordingly, and ensure that clinical trials and submissions are in full compliance with current standards and laws.

Strong Clinical Data and Trial Management Skills

The client is looking for an individual with a strong understanding of clinical trial management, from design to execution. You should have experience in designing, implementing, and monitoring clinical trials, ensuring data integrity and trial compliance. The ability to analyze and interpret clinical data to guide decision-making and ensure the safety and efficacy of diagnostic devices is a critical requirement.

Ability to Build and Lead High-Performing Teams

Leadership in clinical affairs is central to this role, and the client seeks a professional who can build, mentor, and lead a team of clinical professionals. You should have experience fostering a collaborative, results-driven culture, where innovation and accountability thrive. Experience in managing teams that span clinical, regulatory, and operational areas is highly desirable.

Commitment to Improving Patient Outcomes

A deep understanding of the impact that diagnostic devices can have on patient care is essential. The client values a leader who is passionate about driving advancements in healthcare and patient outcomes. You should be able to work closely with R&D and regulatory teams to ensure that clinical trials are aligned with the company’s goals of developing safe, effective, and innovative diagnostic solutions.

Strong Stakeholder and Investor Relations

The client seeks someone who can effectively communicate clinical progress and milestones to both internal stakeholders and external investors. You will need to present clinical data in a clear, concise manner, providing updates on clinical trials and product developments. The ability to maintain transparent communication with key stakeholders is essential for building trust and securing continued support.

Commitment to Operational Excellence and Compliance

The client is looking for a leader who prioritizes operational efficiency and regulatory compliance in clinical affairs. You should have a strong background in ensuring that clinical operations are conducted in full compliance with industry standards and regulations. The ability to identify and mitigate risks in clinical trials and maintain high ethical standards in patient safety is a must.

FAQs About the Role – Head of Clinical Affairs – Diagnostic Devices

What are the key responsibilities of the Head of Clinical Affairs in this role?

As the Head of Clinical Affairs, you will be responsible for overseeing and managing all clinical trial activities, ensuring regulatory compliance, and driving the development of clinical strategies for diagnostic devices. You will lead the clinical affairs team, ensure the safety and efficacy of diagnostic products, manage relationships with regulatory bodies, and oversee the clinical data management process. Additionally, you will collaborate closely with R&D, product development, and marketing teams to ensure clinical trials align with the company’s goals and product development roadmap.

What qualifications and experience are required for this position?

The ideal candidate should have significant experience in clinical affairs, preferably in the diagnostic device or medical device industry. You should have a solid understanding of clinical trial design, regulatory requirements (e.g., FDA, EMA), and data analysis. A medical degree, Ph.D., or advanced degree in a relevant scientific discipline is highly preferred, along with a minimum of 8-10 years of experience in clinical affairs, clinical trial management, or regulatory affairs. Proven leadership skills in managing cross-functional teams are also essential.

What leadership qualities are essential for this role?

The client is seeking a strategic leader with excellent communication skills, the ability to manage complex clinical programs, and a proven ability to lead multidisciplinary teams. You should have a strong track record in clinical trial design, regulatory submission processes, and risk management. The ability to navigate regulatory challenges, motivate teams, and foster innovation is crucial for success in this role. A deep commitment to patient safety and product efficacy will be key in shaping the direction of clinical affairs at the company.

What challenges can I expect in this role?

As the Head of Clinical Affairs, you will encounter challenges such as navigating complex regulatory requirements, managing cross-functional teams, and ensuring the successful execution of clinical trials under tight timelines and budgets. The role will also involve addressing any issues that may arise during clinical trials, such as recruitment challenges or data integrity concerns. Staying up-to-date with evolving regulations and ensuring that trials meet high safety and efficacy standards will be an ongoing challenge.

What is the expected impact of the Head of Clinical Affairs on the company’s growth?

The Head of Clinical Affairs will play a critical role in the successful development and commercialization of diagnostic devices. Your leadership in clinical trial management and regulatory approval processes will directly impact the company’s ability to bring safe and effective products to market. By ensuring compliance and high-quality clinical data, you will contribute significantly to the company’s growth, regulatory success, and overall market positioning.

What is the company’s culture and work environment like?

The company fosters a collaborative, innovative, and patient-focused culture. They prioritize teamwork, transparency, and accountability, creating an environment where employees are encouraged to contribute their expertise and ideas. The company values individuals who are committed to advancing medical innovation and improving patient outcomes. You will have the opportunity to work in a dynamic and fast-paced environment where your contributions in clinical affairs will directly shape the future of the company’s product portfolio.

What Remuneration Can You Expect from This Job?

As the Head of Clinical Affairs for Diagnostic Devices, you can expect a highly competitive and comprehensive compensation package that reflects the seniority and responsibility of the role. The remuneration for this position typically includes the following components:

Base Salary
The base salary for the Head of Clinical Affairs role varies depending on the size and scope of the company. Typically, base salaries range from $150,000 to $250,000 annually, with larger or more established companies offering higher salaries based on experience and the complexity of the clinical affairs role.
Performance-Based Bonuses
In addition to a base salary, you can expect an annual performance-based bonus. This bonus is usually tied to key metrics such as the successful completion of clinical trials, meeting regulatory milestones, and overall company performance. Performance bonuses can range from 20% to 40% of the base salary, depending on both individual and company achievements.
Equity & Stock Options
Many companies in the medical and diagnostic device industry offer equity incentives to align leadership with long-term business goals. These may include stock options, restricted stock units (RSUs), or performance-based shares. Equity compensation can be a significant part of your total remuneration, depending on the company’s structure and growth potential.
Profit-Sharing & Long-Term Incentive Plans (LTIPs)
Some companies provide profit-sharing programs or LTIPs, which reward long-term performance and the achievement of sustained growth. These plans can offer additional financial incentives based on company profitability and the successful development of diagnostic devices.
Executive Benefits & Perks
As part of an executive compensation package, the Head of Clinical Affairs typically receives a comprehensive suite of benefits, including:
- Health, dental, and vision insurance
- 401(k) or pension plans with company contributions
- Executive retirement plans
- Travel allowances and company-provided vehicles
- Executive wellness programs
- Expense accounts for business development and clinical research needs
Signing Bonuses & Relocation Assistance
For highly sought-after candidates, companies may offer signing bonuses or relocation assistance to attract top talent. These incentives typically range from $20,000 to $100,000, depending on the company’s relocation needs and the candidate’s experience.

Total Compensation Potential

When factoring in the base salary, performance bonuses, stock options, and other incentives, total compensation for the Head of Clinical Affairs role can range from $200,000 to $400,000 annually, with the potential for significant increases based on company performance and individual achievements. High-growth companies in the diagnostic devices sector may offer even more lucrative packages.

How to Apply

If you are an experienced and visionary leader with a strong background in clinical affairs, regulatory compliance, and diagnostic devices, we invite you to apply for the Head of Clinical Affairs position in St. Petersburg, FL. This is a unique opportunity to lead clinical strategy and operations, shape the future of diagnostic device development, and drive innovative clinical initiatives.

To apply, please submit the following:

Resume: Detailing your professional experience in clinical affairs, clinical trial management, regulatory compliance, and leadership in the medical or diagnostic device sector.
Cover Letter: Highlighting your expertise in clinical affairs leadership, successful management of clinical trials, and regulatory approval processes. Provide examples of your experience in the diagnostic device industry and demonstrate your ability to lead cross-functional teams and engage with regulatory bodies.
References: A list of professional references who can speak to your experience in clinical affairs and leadership within the diagnostic devices space.

This role offers an exciting opportunity to lead the clinical strategy for innovative diagnostic devices and make a significant impact on the company’s growth and success. Apply today to take the next step in your career as the Head of Clinical Affairs in St. Petersburg, FL!

For more information or to explore similar opportunities, visit our Medical Device Careers Page.

Job Category: Diagnostic Devices

Job Type: Full Time

Job Location: St. Petersburg

Head of Clinical Affairs – St. Petersburg, FL | Diagnostic Devices