Director, Clinical Affairs

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October 30

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INSIGHTEC

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Healthcare • Pharmaceuticals • Science

INSIGHTEC is a company pioneering the use of incisionless focused ultrasound technology to treat neurological disorders such as Essential Tremor and Tremor-Dominant Parkinson’s Disease. Their Exablate Neuro platform allows for precision treatment that is incision-free, guided by MRI and offers real-time safety monitoring, often with immediate results and minimal risks. By targeting specific areas of the brain with acoustic energy, they provide a non-invasive alternative to traditional neurosurgery, promoting life-changing transformations for patients all over the world. INSIGHTEC is committed to advancing healthcare innovation and improving patient care through this transformative technology.

201 - 500 employees

💊 Pharmaceuticals

🔬 Science

💰 $100M Debt Financing on 2022-08

📋 Description

• Provide strategic leadership and oversight of global clinical development programs across multiple therapy platforms and geographies. • Serve as the clinical research authority within cross-functional and global teams, driving the successful execution of clinical strategies that support regulatory approvals, commercialization, and long-term growth. • Build and scale organizational capabilities to conduct clinical programs under responsibility. • Mentor high-performing teams and shape the company’s global clinical affairs vision. • Ensure excellence in design, execution, data integrity, and compliance across global clinical programs.

🎯 Requirements

• 10+ years of progressive experience in clinical research development, expertise in clinical trial strategy within medical device, drug-device combination, or pharmaceutical industries including execution, and regulatory submissions (Class III devices, IDEs/INDs, global pivotal trials). • Minimum of 5 years of experience in drug development studies including submissions to FDA. • Solid track record in successfully designing and executing Phase I – III clinical trials. • Background in Oncology/Neuro-Oncology or Neuro-functional preferred • Strong track record of successful interactions with FDA and OUS (FDA, ISO, ICH/GCP, HIPAA, EU MEDDEV) regulatory agencies, including leading responses to complex regulatory questions. • Experience leading the writing of protocols, investigator brochures, clinical study reports, and manuscripts. • Proven ability to translate clinical data into regulatory and commercial claims and outcomes. • Exceptional communication and presentation skills with experience engaging executive leadership, regulatory authorities, and scientific audiences. • Demonstrated success in building, scaling, and leading high-performance teams. • Minimum of five years of direct line management experience.

🏖️ Benefits

• competitive perks and benefits