Director, Clinical Affairs

Blackrock Neurotech•Salt Lake City, UT

67d•Remote

About The Position

The Director, Clinical Affairs will build and lead Blackrock Neurotech’s clinical function, advance near-term clinical programs, and establish a scalable clinical strategy for the broader product portfolio. The role assesses program readiness, strengthens clinical processes and cross-functional inputs, and personally drives critical clinical work as the organization develops longer-term capabilities. Working with R&D, Regulatory Affairs, Quality, Product Management, clinical investigators, and executive leadership, the Director balances clinical milestones with patient safety, regulatory compliance, and high-quality clinical evidence. The role establishes the clinical strategy, operating model, and evidence foundation for products at increasingly consequential development stages, shaping how programs are designed, prioritized, and executed while building capabilities for future regulatory and commercial milestones. The position leads clinical strategy and development; design and execution of investigations involving implantable neural interfaces and BCI technologies; clinical evidence and data strategy; clinical input to regulatory, quality, and risk-management activities; scientific and investigator relationships; and development of the Clinical organization. Salt Lake City, Utah is the ideal home base, but remote work will be considered. Remote employees are expected to make regular on-site visits for routine work and departmental events. The role is described as high-ownership but not always-on, with an emphasis on sustained, high-quality work and life outside work.

Requirements

Bachelor’s degree in a relevant field.
10 or more years of progressively responsible clinical development or clinical affairs experience in the medical device industry.
At least 3 years of demonstrated leadership experience.
Demonstrated experience building and leading a team from the ground up, including defining organizational structure, hiring key talent, and establishing processes and infrastructure to scale.
Experience advancing Class III and/or permanently implantable medical devices through meaningful stages of clinical development.
Proven ability to design and execute clinical investigations, including IDE/EFS programs and clinical evidence generation.
Ability to work effectively across Clinical, R&D, Regulatory, Quality, and executive leadership, translating clinical requirements into actionable development strategies.
Experience building and appropriately scaling teams in smaller organizations, while operating strategically and personally driving critical activities when needed.
The ability to establish productive clinical partnerships with investigators, academic medical centers, and research institutions.
The role requires regular on-site visits for remote employees; Salt Lake City, Utah is the ideal home base.

Nice To Haves

Experience with BCI, neuroscience, DBS, intracranial recording or stimulation, or another implantable neurotechnology; experience with other complex Class III or permanently implantable medical devices will also be considered.
Experience advancing devices through pivotal development, regulatory approval, or commercialization.
Experience interacting directly with FDA and other global regulatory authorities to advance Class III devices through clinical development, regulatory submission, approval, and commercialization across multiple jurisdictions.
Familiarity with FDA submission processes and global requirements such as EU MDR.
Familiarity with eQMS and design-control platforms such as MasterControl, Ketryx, TrackWise, or comparable systems.

Responsibilities

Develop and execute the company’s clinical development strategy in alignment with R&D, regulatory, and commercial objectives.
Translate product-development objectives into 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.
Partner with Regulatory Affairs on clinical strategies supporting FDA and global regulatory submissions, aligned with product intended use, risk profile, regulatory classification, and development stage.
Lead development and execution of clinical investigations involving implantable neural interfaces and BCI technologies.
Provide strategic input on study design, protocols, endpoints, patient populations, sample sizes, inclusion and exclusion criteria, follow-up requirements, and statistical considerations.
Develop clinically meaningful and scientifically defensible endpoints and assess the suitability of patient populations and clinical-use scenarios for evaluating device safety and performance.
Work with investigators and cross-functional teams to develop 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, and establish clinical-monitoring and study-management processes.
Lead study closeout, post-study assessment, lessons learned, and downstream clinical deliverables, incorporating findings into future clinical and product-development decisions.
Establish systematic approaches for collecting, analyzing, and communicating clinical evidence across the product portfolio.
Evaluate clinical data for safety, performance, efficacy, feasibility, usability, and long-term device performance.
Develop clinical evidence packages for regulatory submissions, investor communications, scientific publications, and internal decisions; distinguish preliminary performance and feasibility data from statistically supported efficacy claims.
Identify clinical evidence gaps and develop strategies to address them; work with Data Science, Biostatistics, and Engineering to translate neural-recording and clinical datasets into meaningful evidence.
Work with Regulatory Affairs on FDA IDE, EFS, 510(k), De Novo, PMA, Breakthrough Device, and other applicable strategies; provide clinical input for Q-Subs, IDE submissions, FDA meetings, and responses to regulatory questions.
Partner with Quality to incorporate clinical processes into the QMS, maintain clinical procedures and work instructions, and ensure investigations comply with applicable regulations, standards, protocols, and ethical requirements.
Contribute clinical input to hazard identification, risk estimation, clinical risk, and residual-risk assessment.
Develop relationships with neurosurgeons, BCI researchers, investigators, key opinion leaders, clinical sites, research institutions, strategic partners, and regulatory authorities.
Monitor developments in BCI, neuroscience, intracranial recording, DBS, neuroprosthetics, and related fields, and incorporate relevant developments into clinical strategy.
Support scientific publications, conference presentations, investigator meetings, and other external scientific activities.
Build and strengthen the Clinical organization by defining roles, capabilities, processes, and infrastructure for the evolving product portfolio.
Set expectations for clinical inputs and deliverables across functions and coach partners in R&D, Engineering, Quality, and Product Management to strengthen clinical readiness and execution.
Assess existing clinical capabilities, processes, and cross-functional inputs, prioritizing improvements for near-term programs and long-term growth.
Establish scalable processes that support transition from early-stage clinical development to larger clinical programs.