Director, Clinical Affairs

The Role

The Director, Clinical Affairs will build and lead Blackrock Neurotech’s clinical function while advancing near-term clinical programs and establishing a scalable clinical strategy for the broader product portfolio. You will assess program readiness, strengthen the clinical processes and cross-functional inputs required for successful execution, and personally drive critical clinical work as the organization builds its longer-term capabilities.

Working closely with R&D, Regulatory Affairs, Quality, Product Management, clinical investigators, and executive leadership, you will balance the urgency of near-term clinical milestones with the rigor required to support patient safety, regulatory compliance, and high-quality clinical evidence. You will also help strengthen the organization's clinical and risk-management capabilities without creating unnecessary barriers to product development.

This is an opportunity to establish the clinical strategy, operating model, and evidence foundation for a portfolio approaching increasingly consequential stages of development. You will shape how clinical programs are designed, prioritized, and executed while building the capabilities needed to support future regulatory and commercial milestones. With direct access to executive decision-makers, you will have meaningful influence over the development of Blackrock Neurotech’s clinical function.

What You'll Do
Clinical Strategy & Development

• Develop and execute the company's overall clinical development strategy aligned with R&D, regulatory and commercial objectives
• Translate product-development objectives into appropriate clinical evidence strategies for investigational and commercial-stage products
• Develop clinical strategies for early feasibility studies (EFS), IDE programs, pivotal investigations, and post-market clinical activities, as appropriate
• Define clinical development plans, evidence requirements, milestones, timelines, and resource requirements for individual products
• Work with Regulatory Affairs to develop clinical strategies that support FDA and global regulatory submissions
• Ensure clinical strategies are appropriately aligned with the intended use, risk profile, regulatory classification, and stage of product development

  Clinical Study Design & Execution

• Lead the development and execution of clinical investigations involving implantable neural interfaces and BCI technologies
• Lead study closeout, post-study assessment, lessons learned, and downstream clinical deliverables to ensure findings are incorporated into future clinical and product-development decisions
• Provide strategic input into study design, protocols, endpoints, patient populations, sample sizes, inclusion/exclusion criteria, follow-up requirements, and statistical considerations
• Develop clinically meaningful and scientifically defensible primary and secondary endpoints
• Assess the appropriateness of proposed patient populations and clinical-use scenarios for evaluating device safety and performance
• Work with investigators and cross-functional teams to develop practical clinical workflows for implantation, recording, stimulation, device management, follow-up, and explantation where applicable
• Oversee clinical research organizations, clinical vendors, and other external partners as required
• Establish appropriate clinical-monitoring and study-management processes

  Clinical Evidence & Data Strategy

• Establish a systematic approach for collecting, analyzing, and communicating clinical evidence across the company's product portfolio
• Evaluate clinical data for safety, performance, efficacy, feasibility, usability, and long-term device performance
• Develop clinical evidence packages supporting regulatory submissions, investor communications, scientific publications, and internal decision-making
• Ensure appropriate distinction between preliminary clinical performance, feasibility data, and statistically supported efficacy claims
• Identify gaps in clinical evidence and develop strategies to address them
• Work with Data Science, Biostatistics, and Engineering teams to translate neural-recording and clinical datasets into meaningful clinical evidence

  Regulatory & Quality Interface

• Work closely with Regulatory Affairs to support FDA IDE, EFS, 510(k), De Novo, PMA, Breakthrough Device, and other applicable regulatory strategies
• Provide clinical input into regulatory interactions, including Q-Subs, IDE submissions, FDA meetings, and responses to regulatory questions
• Partner with Quality to ensure clinical processes are appropriately incorporated into the company's QMS
• Ensure clinical investigations are conducted in accordance with applicable regulations, standards, protocols, and ethical requirements
• Support development and maintenance of clinical procedures (SOPs), work instructions, and clinical quality systems
• Contribute to risk-management activities by providing clinical input into hazard identification, risk estimation, clinical risk, and residual-risk assessment

  Clinical & Scientific Leadership

• Develop relationships with leading neurosurgeons, BCI researchers, and other key clinical stakeholders
• Establish and manage a network of clinical investigators and key opinion leaders
• Identify appropriate clinical sites and investigators for early and later-stage studies
• Serve as a clinical representative with investigators, research institutions, strategic partners, and regulatory authorities
• Monitor developments in BCI, neuroscience, intracranial recording, DBS, neuroprosthetics, and related fields and translate relevant developments into the company's clinical strategy
• Support scientific publications, conference presentations, investigator meetings, and other external scientific activities

  Clinical Organization Development

• Build and strengthen the company’s Clinical organization by defining the roles, capabilities, processes, and infrastructure needed to support the evolving product portfolio
• Establish clear expectations for clinical inputs and deliverables across functions, coaching partners in R&D, Engineering, Quality, and Product Management to strengthen clinical readiness and execution
• Assess the maturity of existing clinical capabilities, processes, and cross-functional inputs, prioritizing the improvements required to support near-term programs and long-term growth
• Establish scalable processes that can transition from early-stage clinical development to larger clinical programs

The Experience You'll Need

• Bachelor’s degree in a relevant field and 10+ years of progressively responsible clinical development or clinical affairs experience within the medical device industry
• 3+ years of demonstrated leadership experience, demonstrated experience building and leading a team from the ground up, including defining the organizational structure, hiring key talent, and establishing the processes and infrastructure needed to scale
• Demonstrated experience advancing Class III and/or permanently implantable medical devices through meaningful stages of clinical development, ideally including pivotal development, regulatory approval, or commercialization
• Proven ability to design and execute clinical investigations, including experience with IDE/EFS programs and clinical evidence generation
• Experience with BCI, neuroscience, DBS, intracranial recording or stimulation, or another implantable neurotechnology is strongly preferred; experience with other complex Class III or permanently implantable medical devices will also be considered
• Ability to work effectively across Clinical, R&D, Regulatory, Quality, and executive leadership while translating clinical requirements into actionable development strategies
• Experience building and appropriately scaling teams in smaller organizations, with the ability to operate strategically while personally driving critical activities when required
• Experience interacting directly with FDA and other global regulatory authorities to advance Class III medical devices through clinical development, regulatory submission, approval, and commercialization across multiple jurisdictions, including familiarity with applicable FDA submission processes and global requirements such as EU MDR, is preferred
• Experience establishing productive clinical partnerships with leading investigators, academic medical centers, and research institutions
• Familiarity with eQMS and design-control platforms such as MasterControl, Ketryx, TrackWise, or comparable systems is preferred

Working Location:

Making Salt Lake City, UT your home base is ideal; however, we will consider remote work for this position. We ask that remote employees commit to regular on-site visits for routine work and departmental events.

How We Work

We are a small, experienced team working on consequential problems.

• We take ownership of outcomes and follow through with clarity and accountability
• We prioritize sustained, high-quality work over performative urgency
• We value rigor, sound judgement and thoughtful decision-making
• We collaborate deliberately: low ego, high trust and high context

This is a high-ownership role, but it is not an "always-on" one. We expect strong work and our people to have a life outside of it.