Clinical Trial Director

Regulatory       ·       Fremont, CA        ·       Full time

As the Clinical Trial Director, you’ll work closely with some of the most innovative doctors and top engineers, as well as working with Neuralink’s first Clinical Trial participants! You will lead and help build the team responsible for enabling Neuralink’s clinical research activities and developing the regulatory interactions that come with a fast-paced and ever-evolving environment. You are mission-driven and are able to meet tight deadlines with accuracy and efficiency.

About you

• Dedicated to the highest standards of clinical trial design and management
• Meticulous attention to detail and organizational skills
• Effective multitasking skills
• Great verbal and written communication skills
• Driven to see projects through to completion
• Resourceful, flexible, and adaptable; no task is too big or too small
• Ability to thrive in a dynamic and constantly changing environment
• Ability to work effectively and collaboratively in a cross-disciplinary team environment
• Willing and eager to go above and beyond/flexible schedule

Key Qualifications

• Understanding of the Clinical Trial process from beginning to end including: experience managing critical FDA interactions, trial site management, and have worked with CRO’s through the Early Feasibility and Pre-Market/Pivotal Investigational Device Exemption (IDE) process 
• Experience with implantable Class II or Class III medical devices 
• Work collaboratively and effectively with investigators, research site staff, and Neuralink teammates
• Experience and ability to work in the operating room environment
• Working knowledge of FDA regulations related to clinical studies
• Working knowledge of medical and scientific terminology
• Demonstrated communication and management skills
• Demonstrated problem-solving abilities in managing clinical sites and demonstrated tactfulness and diplomacy in communicating with investigators, participants, and study coordinators

Preferred Qualifications 

• Thorough knowledge of Good Clinical Practice 
• Understanding of Class III implantable neuromodulation devices 
• Experience in designing and leading IDE studies as a Sponsor or Investigator 
• Minimum 3 years of US medical device regulatory experience 

Examples of concrete duties

• Support Neuralink clinical studies, including selection of CRO, site qualification and initiation, training, monitoring, close-out activities, device accountability, etc. as well as ensuring compliance with regulations and standards for clinical research
• Interact directly with regulatory agencies and the site-responsible clinical trial investigator
• Ensure timely and thorough monitoring visits to review and assure the rights, welfare, and safety of study participants are protected, and ensure integrity of clinical data with respect to accuracy, accountability, documentation, and adherence to procedures through review of eCRFs, source documents, medical records, and regulatory documents.
• Support site initiation activities, audits and site audit preparation in anticipation of site inspections.
• Develop and author regulatory submissions and provide critical input on cross-functional project teams
• Develop and implement SOPs for clinical research/trials and related activities
• Maintain a working knowledge of and assure compliance with Good Clinical Practices, Federal Regulatory requirements, Risk‐Based Approach to Monitoring, and Neuralink SOPs
• Review Change Orders and assess regulatory impact of product changes on regulatory strategy and submissions per standard procedures
• Assist Community Engagement team with recruitment of study participants 

What we offer:

• An opportunity to change the world and work with some of the smartest and the most talented experts from different fields. 
• Growth potential. We rapidly advance team members who have an outsized impact. 
• Excellent medical, dental, and vision insurance through a PPO plan; parental leave.
• Flexible time off + paid holidays.
• Equity + 401(k) plan.
• Commuter Benefits.
• Meals provided.

Neuralink provides equal opportunity in all of our employment practices to all qualified employees and applicants without regard to race, color, religion, gender, national origin, age, disability, marital status, military status, genetic information or any other category protected by federal, state and local laws.  This policy applies to all aspects of the employment relationship, including recruitment, hiring, compensation, promotion, transfer, disciplinary action, layoff, return from layoff, training and social, and recreational programs. All such employment decisions will be made without unlawfully discriminating on any prohibited basis.