Head Of Clinical

Team Description:

The Neuralink Clinical team is at the heart of an ecosystem that merges neuroscience, engineering, and medicine. We work to shape the future of brain-computer interface (BCI) technology through the planning, launch, and execution of groundbreaking human clinical trials. Our team is built on a foundation of excellence, aiming to uphold the highest standards of Good Clinical Practice (GCP) while redefining what's possible and revolutionizing the way people interact with technology. Through strict compliance with ethical and regulatory protocols, we focus on ensuring the well-being of our trial participants while advancing the frontiers of neuroscience! Every day will bring fresh challenges and unprecedented opportunities to pioneer new approaches in the pursuit of our mission. From navigating clinical pathways, designing trial protocols and documentation, and executing clinical trials, our team is instrumental in translating Neuralink's BCI technology for use in people. 

As the Head of Clinical, you will be accountable for excellence in our clinical operations and execution of our trials. This position requires end-to-end understanding of Clinical trial processes, strong knowledge of regulatory requirements, and a proven track record in successful clinical trial management. You'll lead cross-functional efforts to drive the execution of Clinical trials and operations, ensuring compliance with all applicable regulations, and partner closely with engineering teams.

Job Responsibilities and Description:

• Oversee the planning, initiation, execution, and closure of Clinical trials, ensuring adherence to timelines, budgets, and quality standards
• Collaborate with internal stakeholders to design and optimize clinical trial protocols
• Build and lead a high-performing clinical team dedicated to the highest standards of Clinical trial design and management to achieve the company's objectives and meet all regulatory requirements
• Collaborate with engineering, regulatory, and preclinical leads on US and international regulatory filings
• Ensure compliance with Neuralink SOPs and all applicable regulatory requirements, including FDA regulations, Good Clinical Practice (GCP) guidelines, and international standards
• Oversee the collection, management, and analysis of Clinical trial data, ensuring accuracy, integrity, and compliance with data protection regulations
• Develop and implement robust safety monitoring plans and proactively identify and mitigate potential risks related to clinical trial operations or participant safety

Key Qualifications:

• 7+ years of professional experience in clinical trial management in the medical device industry
• Understanding of the clinical trial process from beginning to end, including: experience managing interactions with regulatory bodies, site identification through closeout, CRO management experience both within the US and internationally
• Significant contributor to clinical protocol for either EFS or Pivotal Study for FDA Class III device OR Class II surgical device ("Class II Special Controls")
• Led or supported Pivotal Study or PMA for FDA Class III device
• Led or supported international study approval for a novel / significant risk device, like FDA Class III device OR Class II surgical device ("Class II Special Controls" or "de-novo 510k")
• Strong knowledge of FDA regulations, Good Clinical Practice (GCP) guidelines, and international regulatory requirements

Preferred Qualifications:

• Led or supported clinical strategy from early feasibility study (EFS) through Pivotal Study for Class III devices
• Demonstrated knowledge in medical device regulation and reimbursement pathways
• Experience with robotics, active implantable devices, software, and/or cybersecurity-related regulatory filings