Director, Clinical Strategy & Evidence

Blackrock Neurotech LLC; Salt Lake City (UT); Híbrido; USD 190 000 - 270 000; Tempo integral

Resumo da oferta

Blackrock Neurotech LLC is seeking a Director of Clinical Affairs to lead and scale the clinical functions for a portfolio of neural interface products. You will shape near-term clinical programs, design robust evidence strategies, and collaborate with R&D, regulatory, and quality teams to ensure patient safety and regulatory readiness.

You will build relationships with investigators, sites, and regulatory authorities while guiding clinical development from early feasibility through pivotal

Qualificações

• Bachelor’s degree in a relevant field with 10+ years of clinical development experience in medical devices.
• Proven leadership of teams from the ground up and scaling clinical programs.

Responsabilidades

• Develop and execute the overall clinical development strategy aligned with R&D, regulatory and commercial goals.
• Lead clinical investigations involving implantable neural interfaces and BCI technologies.
• Establish systematic collection, analysis and communication of clinical evidence across product lines.
• Interface with Regulatory Affairs and Quality to support FDA IDE/EFS, submissions and compliance.
• Build and scale the Clinical organization with defined roles, processes and infrastructure.

Conhecimentos

Leadership

Clinical development

FDA regulatory

BCI/neural interfaces

Data analysis

Formação académica

Bachelor’s degree in a relevant field

Ferramentas

eQMS (MasterControl/Ketryx/TrackWise)

Descrição da oferta de emprego

Blackrock Neurotech LLC is seeking a Director of Clinical Affairs to lead and scale the clinical functions for a portfolio of neural interface products. You will shape near-term clinical programs, design robust evidence strategies, and collaborate with R&D, regulatory, and quality teams to ensure patient safety and regulatory readiness.

You will build relationships with investigators, sites, and regulatory authorities while guiding clinical development from early feasibility through pivotal