Director Clinical Affairs

Fractional Clinical Study Strategy Consultant (Cardiovascular Medical Devices)

Location: Remote (Europe)

Contract Type: Fractional Consultant / Contractor

Start Date: ASAP

Reporting To: CEO

We are supporting an innovative medical device company developing Class III implantable cardiovascular technologies and are seeking an experienced Clinical Study Strategy Consultant to provide high-level clinical and regulatory leadership on a fractional basis.

This is a strategic role for a senior clinical professional with deep experience designing and executing clinical development programmes for implantable cardiovascular devices, including FDA approval pathways, European regulatory submissions, and reimbursement strategies.

Key Responsibilities

• Define the overall clinical evidence strategy for Class III implantable cardiovascular devices.
• Develop clinical study roadmaps to support regulatory approvals in both the US and Europe.
• Design clinical trial strategies, including:
• Primary and secondary endpoints
• Patient population selection
• Sample size recommendations
• Study duration and follow-up requirements
• Statistical considerations
• Advise leadership on FDA clinical requirements, PMA pathways, and interactions with regulatory authorities.
• Support European clinical and regulatory strategies under MDR requirements.
• Develop evidence-generation plans to support market access and reimbursement submissions.
• Provide guidance on clinical evaluation, post-market clinical follow-up, and health economic evidence requirements.
• Collaborate closely with executive leadership, regulatory affairs, clinical affairs, and external stakeholders.
• Act as a strategic advisor to the CEO on clinical development decisions and investment priorities.

Essential Experience

• Significant experience developing clinical strategies for Class III implantable cardiovascular medical devices.
• Proven track record supporting successful FDA approvals (PMA and/or IDE studies).
• Strong understanding of European MDR clinical evidence requirements.
• Experience defining clinical endpoints, study design, patient enrolment strategies, and statistical approaches.
• Experience preparing clinical evidence packages to support both regulatory approval and reimbursement/market access.
• Deep understanding of cardiovascular clinical trials and investigator engagement.
• Ability to operate at a strategic level with minimal oversight.

Desirable

• Experience with structural heart, cardiac rhythm management, vascular implants, heart failure, or other implantable cardiovascular technologies.
• Previous experience advising venture-backed, growth-stage, or start-up medical device companies.
• Experience presenting to investors, notified bodies, FDA reviewers, or reimbursement authorities.

What's on Offer

• Highly flexible fractional engagement.
• Fully remote position from anywhere in Europe.
• Direct access to executive leadership and significant influence on company strategy.
• Opportunity to shape the clinical and commercial success of an innovative cardiovascular technology.

If you have successfully guided implantable cardiovascular devices through clinical development, FDA approval, and reimbursement pathways, we would be keen to speak with you.