Director, Clinical Strategy & Trials

Blackrock Neurotech LLC; United States; Híbrido; USD 180 000 - 260 000; Tempo integral

Resumo da oferta

Blackrock Neurotech LLC seeks a Director of Clinical Affairs to build and lead the clinical function, advancing near-term programs while shaping a scalable strategy across the product portfolio.

You will partner with R&D, Regulatory, Quality and Product Management to ensure patient safety, regulatory compliance, and robust clinical evidence, while developing long-term capabilities and an evidence foundation for future milestones.

Qualificações

• Bachelor's degree in a relevant field; 10+ years clinical development or clinical affairs experience preferred.
• Proven leadership experience building or leading clinical teams.
• Experience advancing Class III or implantable medical devices through development, regulatory and ideally commercialization.

Responsabilidades

• Develop and execute the company's overall clinical development strategy aligned with R&D, regulatory and commercial objectives.
• Lead the design and execution of clinical investigations for implantable neural interfaces and BCI technologies.
• Collaborate with Regulatory, Quality and cross-functional teams to support FDA and global submissions and regulatory interactions.
• Establish clinical evidence packages for regulatory, investor, and internal decision-making.

Conhecimentos

Clinical leadership

Strategic planning

Cross-functional work

Regulatory collaboration

FDA interactions

Formação académica

Bachelor's degree in a relevant field

Ferramentas

MasterControl

Ketryx

TrackWise

Descrição da oferta de emprego

Blackrock Neurotech LLC seeks a Director of Clinical Affairs to build and lead the clinical function, advancing near-term programs while shaping a scalable strategy across the product portfolio.

You will partner with R&D, Regulatory, Quality and Product Management to ensure patient safety, regulatory compliance, and robust clinical evidence, while developing long-term capabilities and an evidence foundation for future milestones.