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ClearPoint Neuro, Inc. · 16 hours ago

Scientist

San Diego, CA

Full-time

Onsite

Mid, Senior Level

$115K/yr - $155K/yr

ClearPoint Neuro is a device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine. The Scientist will primarily serve as a Study Director for nonclinical studies, ensuring the highest quality of study-related activities and collaborating with various teams to execute commissioned studies and develop novel medical devices and therapeutics.

BiotechnologyHealth CareHospitalMedical Device

H1B Sponsor Likely

Hiring Manager

Geary “Chip” Smith

Responsibilities

Primarily serves as a Study Director for nonclinical studies under Good Laboratory Practice (GLP) regulations

Serves as the primary customer-facing contact for commissioned studies from sponsors

May serve as a member of the Institutional Animal Care and Use Committee and/or Safety Committee

Ensures all study-related activities for nonclinical studies are carried out to the highest quality level achievable

Interfaces with Veterinary, Research Services, and Quality Assurance staff to ensure proper execution of all assigned commissioned studies

Understands all regulatory requirements, relevant Testing Facility standard operating procedures (SOPs), and other internal guidance applicable to all assigned commissioned studies

Independently and collaboratively generates novel study designs for internal research and development efforts for novel medical devices and therapeutics

Takes part in business development activities to expand opportunities for ClearPoint Neuro, Inc

Effectively communicates verbally and via writing to both study sponsors and internal staff

Demonstrates the leadership skills to efficiently and effectively complete complex cross-departmental projects

Serves as a Subject Matter Expert for internal controlled documents as appropriate

Generates data for publication and presentation at scientific conferences

Participates in the grant authoring process for funding projects collaboratively with study sponsors and for funding internal projects

Interfaces with the Regulatory team for submissions to appropriate governing bodies, including the FDA, EMA and other foreign entities

Develops the ability to execute the use of all medical devices and software products in the ClearPoint Neuro portfolio at the highest achievable level

Serves as a consulting expert on the use of all medical devices and software products in the ClearPoint Neuro portfolio

Provides scientific and technical leadership to disciplines related to image-guided technology, neuroanatomy, neurosurgery, and small and large animal studies

Collaborates with senior management to identify and evaluate new target opportunities for existing programs, as well as developing new initiatives

Collaborates closely with Engineering to design, develop, and implement medical device prototypes for targeted drug delivery to the central nervous system, including the spine

Responsible for developing clinically relevant neurosurgical approaches for drug delivery in large animals

Other duties and responsibilities as necessary

Qualification

Study Director experienceLaboratory Practice (GLP)Regulatory submissionsMedical device expertiseNeuroanatomy knowledgeScientific communicationLeadership skillsCollaboration skills

Required