EPM Scientific · 3 days ago
Director Clinical Affairs
United States
Full-time
Remote
Director/Executive
$180K/yr - $230K/yr
10+ years expEPM Scientific is a rapidly growing Structural Heart company seeking a Director of Clinical Affairs to guide its clinical and regulatory journey. The role involves leading global pivotal trials, shaping study design, and working closely with cross-functional teams to influence product development and risk management.
BiotechnologyRecruiting
Hiring Manager
Luke Newton
Responsibilities
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
Qualification
Required
10+ years of clinical research experience in medical devices
Experience leading global, multi‑center pivotal trials
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
Preferred
Background in Structural Heart or Interventional Cardiology
Company
EPM Scientific
EPM Scientific is proud to be a leading specialist recruitment agency for the life sciences industry.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
S
Sean P.
Senior Vice President Commercial - Field at EPM Scientific
Recent News
BioSpectrum Asia
2023-12-23
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