Director Clinical Affairs

EPM Scientific; United States; On-site; USD 180,000 - 280,000; Full time

Job summary

A rapidly growing Structural Heart company is looking for a Director of Clinical Affairs. This high-visibility role involves leading global pivotal trials and influencing regulatory milestones. The candidate should have over 10 years of clinical research experience in medical devices and a strong grasp of regulatory pathways. This position is pivotal in shaping therapies for patients with structural heart disease, requiring excellent communication and leadership skills.

Qualifications

• 10+ years of clinical research experience in medical devices.
• Ability to manage external partners, CROs, and global study stakeholders.
• 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 stakeholders.
• Clear communication and leadership presence.

Responsibilities

• Lead global pivotal trials from concept through delivery.
• Shape study design, protocol development, and site strategy.
• Work closely with cross-functional teams.

Skills

Clinical research experience

Leadership presence

Clear communication

Regulatory strategy

Cross-functional leadership

Vendor management

Job description

Director of Clinical Affairs - Structural Heart

USA - Confidential Search

Why This Role Matters

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.

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