Senior Surgical Specialist, Gene Therapy Delivery, CNS

The
*** Senior Surgical Specialist, Gene Therapy Delivery, Central Nervous System (CNS)
*** will be primarily responsible for supporting clinical neurosurgeons and their staff with carrying out safe and effective delivery of Ask Bio gene therapies as part of therapeutic clinical trials. The Senior Surgical Specialist will work closely with the Senior Director, CNS Gene Therapy Delivery s individual will receive technical training, and all job-related knowledge required through training provided from these team members.

The Senior Surgical Specialist will work to establish strong relationships with other CNS Gene Therapy Team members, as well as the Site Neurosurgical Principal Investigators (PIs) and their site support staff who are participating in Ask Bio Gene Therapy Trials. Past clinical experience and the ability to build trust quickly will allow for effective integration withing the Delivery Team. The chosen candidate will also identify and routinely use the most optimal, cost-efficient best practices and will continually evaluate the efficacy and appropriateness of relevant advances in the field of CNS Gene Therapy.

The Senior Surgical Specialist will work collaboratively with regulatory affairs in support of device-related regulatory filings associated with multinational clinical investigations.
* Support surgical delivery of Ask Bio gene therapies at participating neurosurgical sites in Europe, collaborating with Surgical Site PIs to execute safe and effective gene therapies aligned to study protocols and CNS Gene Therapy Team trainings
* Assist CNS Gene Therapy Delivery Team in formulating and instituting educational programs for surgeons and operating room staff at selected surgical sites regarding CNS gene therapy delivery methods and technologies
* Support development of efficient site-specific surgical workflows for delivery of CNS gene therapies
* Create, update, and deploy educational modules and materials alongside CNS Gene Therapy leadership
* Facilitate the coordination and implementation of novel medical devices, methods, and imaging protocols to advance surgical safety during gene therapy delivery
* Deliver training to Neurosurgical PIs, providing technical input on surgical delivery aspects during CNS Gene Therapy procedures
* Assist in identifying and evaluating future neurosurgical sites and investigators to participate in Ask Bio CNS gene therapy trials
* Build and maintain relationships with site PIs and other neurosurgical KOLs
* Attend neurosurgical procedures to support Ask Bio gene therapy studies and provide feedback to Ask Bio teams regarding the quality of site personnel and the deployment of technologies and surgical procedures at specific sites
* Support Senior Director with clinical evaluation of novel gene therapy devices
* Collect and study information about new and existing products and share learnings with clinical team members
* Work on internal integrated product teams (IPTs) to support the development of new devices and procedures and provide technical support to Ask Bio Team members
* Ensure consistent practices with the highest ethical standards in compliance with internal SOPs, local laws and regulations
* Maintain expertise and continuing clinical and technical proficiency in product use that goes beyond features and benefits, focusing also on design, development, and clinical application
* Follow developments and trends in the scientific literature and foster relationships with external experts to gain strategic insights into further development of Ask Bio programs
* Bachelor’s degree in science, nursing, biomedical engineering or related field with 8+ years’ relevant work experience OR Master’s degree in science, nursing, biomedical engineering or related field with 6+ years’ relevant work experience
* Experience working with neurosurgical device(s)
* Familiarity with brain imaging modalities (MRI and CT)
* Expertise in partnering effectively with surgeons and staff in an operating room environment
* Strong instructional abilities with the capacity to train medical personnel on new techniques and technologies in a surgical environment
* Excellent relationship…