USAVeterinary Pathologist
1 мес. назад
USAJunior
Provide histopathologic analysis and diagnostic pathology services to evaluate brain-computer interface device safety and tissue responses in preclinical studies.
Обязанности
- The Veterinary Pathologist will provide critical diagnostic, analytical, and regulatory pathology support for ’s preclinical programs. This role ensures high-quality histopathologic data generation and compliance for all research activities supporting the development of medical devices. Responsibilities include:
- Perform necropsies, tissue collection, and tissue examinations for preclinical studies; ensure high-quality samples for histopathologic evaluation of device implantation sites and other non-target tissues.
- Conduct thorough gross and microscopic (histopathologic) examination of tissues with emphasis on device-tissue interfaces, foreign body responses, inflammation, gliosis, neuronal viability, other changes in the central nervous system and surrounding structures relevant to implanted brain-computer interfaces.
- Interpret pathological findings, establish diagnoses, and prepare comprehensive, regulatory-quality pathology reports documenting methods, observations, interpretations, diagnoses, and recommendations suitable for internal leadership review, external peer review, and inclusion in GLP study reports for FDA premarket submissions (IDE, PMA, etc.)
- Collaborate with Preclinical study directors, veterinarians, and researchers on the design and execution of safety studies in accordance with FDA guidance and relevant standards; contribute pathology expertise to protocol development, endpoint selection, and study governance.
- Ensure all pathology activities comply with GLP regulations (21 CFR Part 58), including accurate specimen tracking, chain of custody, documentation, SOP adherence, equipment calibration/maintenance, and quality control; support QA audits and potential inspections of pathology data and processes.
- Lead or actively participate in investigations of unexpected tissue findings, adverse events, and device-related abnormalities; perform root cause analysis and contribute pathology data for device design refinements.
- Provide pathology consultation and subject matter expertise to cross-functional teams (Engineering, Clinical, Regulatory, Animal Care) regarding tissue collection best practices, fixation methods, handling of implanted devices, and interpretation of challenging histopathology findings.
- Maintain laboratory equipment, develop and update pathology SOPs and protocols, perform routine quality control, and ensure a safe, organized, and compliant laboratory environment (including BSL-2 practices for handling animal tissues and potentially hazardous materials).
- Stay current with advancements in veterinary pathology, digital pathology, medical device regulatory science, biocompatibility assessment, and CNS histopathology; participate in continuing education and contribute to scientific knowledge through publications or presentations where appropriate.
- Support training and mentorship of technical staff, research associates, and junior team members on necropsy techniques, tissue handling/processing, histopathology slide reading, digital pathology tools, and GLP-compliant documentation practices.
Требования
- Doctor of Veterinary Medicine (DVM/VMD) or equivalent degree.
- Board certification (Diplomate) or board eligibility to sit for the ACVP certifying examination in Anatomic Pathology.
- Strong knowledge of veterinary anatomy, physiology, and pathology with demonstrated proficiency in gross necropsy, tissue trimming/processing, and microscopic histopathologic examination across common laboratory animal species.
- Experience working in or supporting a GLP-regulated (or similarly quality-controlled) preclinical environment, with understanding of 21 CFR Part 58 requirements for nonclinical laboratory studies.
- Excellent diagnostic skills, attention to detail, and ability to interpret complex and subtle pathological changes, particularly those associated with implanted medical devices, foreign body reactions, and CNS tissue responses.
- Proven ability to author clear, thorough, well-organized, and defensible pathology reports suitable for regulatory review and inclusion in GLP final study reports.
- Strong written, verbal, and interpersonal communication skills with ability to convey complex pathology findings and recommendations effectively to diverse audiences (veterinarians, engineers, researchers, regulatory specialists, leadership).
- Physical capability to perform necropsies and handle animal specimens (including lifting/manipulating carcasses as needed), work in a BSL-2 or appropriate laboratory environment, and tolerate exposure to chemicals, fixatives, and potentially hazardous biological materials while following safe work practices.
Будет плюсом
- 1+ years of relevant post-residency or industry experience in veterinary pathology, ideally in a medical device, biotechnology, pharmaceutical, or CRO setting supporting preclinical safety assessment of implanted devices, combination products, or neurotechnologies.
- Experience evaluating histopathology in the ovine (sheep) model, particularly for large animal preclinical studies of implanted neurodevices.
- Direct experience evaluating histopathology of implanted medical devices, with strong preference for experience assessing CNS or neural tissue responses to microelectrodes, threads, or similar BCI components (e.g., gliosis, neuronal loss, device migration).
- Prior experience contributing pathology endpoints and reports to regulatory submissions (IDE, GLP study reports, premarket applications) or participating in FDA interactions/audits related to pathology data.
- Familiarity with FDA guidance documents on animal studies for medical devices, biocompatibility evaluation (ISO 10993 series), and toxicologic pathology principles.
- Experience developing, validating, or optimizing tissue processing/histology pipelines, SOPs, or high-throughput workflows in a regulated preclinical setting.
- Subspecialty training, interest, or certification in neuropathology, toxicologic pathology, or related fields.
- Experience supporting or leading pathology aspects of GLP studies, including coordination with external peer review pathologists and preparation of reports for regulatory agencies.
Условия
- The anticipated base salary for this position is expected to be within the following range. Your actual base pay will be determined by your job-related skills, experience, and relevant education or training. We also believe in aligning our employees’ success with the company's long-term growth. As such, in addition to base salary, offers equity compensation (in the form of Restricted Stock Units (RSU)) for all full-time employees.
- Full-time employees are eligible for the following benefits listed below.
- An opportunity to change the world and work with some of the smartest and 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
- Paid holidays
- Commuter benefits
- Meals provided
- Equity (RSUs) *Temporary Employees & Interns excluded
- 401(k) plan *Interns initially excluded until they work 1,000 hours
- Parental leave *Temporary Employees & Interns excluded
- Flexible time off *Temporary Employees & Interns excluded
Другое
- We are creating devices that enable a bi-directional interface with the brain. These devices allow us to restore movement to the paralyzed, restore sight to the blind, and revolutionize how humans interact with their digital world.
- Join the Preclinical team at , where our mission is to generate high-quality safety, biocompatibility, and performance data for cutting-edge brain-computer interface (BCI) technologies through rigorous, ethical, and GLP-compliant research studies. The Veterinary Pathologist plays a critical role in this mission by delivering expert histopathologic analysis, diagnostic pathology services, and pathology expertise to evaluate device-tissue interactions, tissue responses to implanted BCI components (such as microelectrode arrays and threads), and overall device safety. This role works closely with Veterinary Medicine, Animal Care, Engineering, Translational Research, and Regulatory teams to support study design, data interpretation, regulatory submissions, and continuous device refine