Director Clinical Affairs
Director Clinical Affairs (medical device)
USA
Salary ($180,000 - $210,000)
Company Summary
We're partnered with a Structural Heart company redefining what's possible in cardiovascular intervention. Backed by world‑class investors and led by innovators in the space, this organization is rapidly emerging as a category leader with a highly differentiated technology poised to transform patient outcomes globally. As the company prepares to scale, we're seeking a Director of Clinical Affairs who can drive global pivotal studies and help bring this life‑changing therapy to market.
Responsibilities
- Lead strategy, planning, and execution of global pivotal clinical trials for novel structural heart technologies.
- Oversee study design, protocol development, clinical operations, site selection, enrollment, and data quality management.
- Partner cross‑functionally with R&D, Regulatory, and executive leadership to align clinical strategy with regulatory and commercial goals.
- Manage CROs, vendors, and global clinical partners to ensure on‑time, high‑quality study delivery.
Qualifications
- 10+ years of clinical research experience within medical devices; strong preference for Structural Heart or Interventional Cardiology.
- Proven track record leading global pivotal trials from concept through execution.
- Deep understanding of FDA, EU, and international regulatory pathways for high‑risk cardiovascular devices.
- Experience managing complex, multi‑center global studies and external partners.
- Exceptional leadership, communication, and strategic problem‑solving skills.
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