Director Clinical Affairs
Director of Clinical Affairs - Structural Heart
USA - Confidential Search
A rapidly growing Structural Heart company is entering a pivotal stage in its clinical and regulatory journey and is seeking a Director of Clinical Affairs to help guide the next phase of development. Backed by strong investors and led by experienced innovators in cardiovascular intervention, the organization is advancing a differentiated therapy with the potential to significantly improve outcomes for patients with structural heart disease.
Why This Role Matters
This is an opportunity to step into a high‑visibility role at a time when your leadership will shape global pivotal studies and influence key regulatory milestones. You'll be joining a company where clinical strategy sits at the center of decision‑making, and where the work you do will directly impact timelines, data quality, and access for patients who currently have limited treatment options.
For candidates looking to build a track record in leading major submissions, driving global evidence generation programs, and partnering closely with senior leadership, this role offers substantial growth and résumé‑defining experience.
The Opportunity
In this position, you'll guide the strategy and execution of the company's most important clinical programs. You will:
- Lead global pivotal trials from concept through delivery
- Shape study design, protocol development, and site strategy
- Work closely with cross‑functional teams across R&D, Regulatory, Medical Affairs, and executive leadership
- Partner with leading investigators and global clinical sites
- Provide clinical insights that influence product development and risk management
- Represent Clinical Affairs with investigators, advisory boards, and regulatory stakeholders
The role combines hands‑on leadership with strategic impact and is ideal for someone looking to be closely involved in shaping a therapy through the final stages of development.
What You Bring
The strongest candidates will bring:
- 10+ years of clinical research experience in medical devices
- Experience leading global, multi‑center pivotal trials
- Background in Structural Heart or Interventional Cardiology (preferred but not required)
- Strong understanding of FDA, EU, and international regulatory pathways for high‑risk devices
- Ability to manage external partners, CROs, and global study stakeholders
- Clear communication, leadership presence, and sound judgment
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