Senior Surgical Specialist, Gene Therapy Delivery, CNS

AskBio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson’s disease, and Pompe disease. AskBio’s gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive array of capsids and promoters. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, Scotland, the company has generated hundreds of proprietary capsids and promoters, several of which have entered pre-clinical and clinical testing.

Our vision: Pioneering science to create transformative molecular medicines.

Our mission: Lead innovative science and drive clinical outcomes to transform people's lives.

Our principles:

• Advance innovative science by pushing boundaries. 

• Bring transformative therapeutics to patients in need.  

• Provide an environment for employees to reach their fullest potential.  

Our values:

• Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need.

• Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view.

• Embrace Responsibility. We are humbled by the enormity of our mission.  We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers.

• Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action.

• Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what’s right in every situation. Make clear commitments and follow through.

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 AskBio gene therapies as part of therapeutic clinical trials. The Senior Surgical Specialist will work closely with the Senior Director, CNS Gene Therapy Delivery at AskBio. This 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 AskBio 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.

This is a remote-based position ideally situated in Bristol, London, or Warsaw but can be flexible. This position reports to the Senior Director, Gene Therapy Delivery.

Job Responsibilities

• Support surgical delivery of AskBio 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 AskBio CNS gene therapy trials

• Build and maintain relationships with site PIs and other neurosurgical KOLs

• Attend neurosurgical procedures to support AskBio gene therapy studies and provide feedback to AskBio 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 AskBio 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 AskBio programs

Minimum Requirements

• 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 building skills across various levels and functions of an organization or site including nursing, medical, and surgical colleagues

• Ability to work both independently and as a trusted, supportive team member in a dynamic environment

• Positive and professional attitude with a passion for science and technology in the service of clinical study participants, site treatment teams, and sponsoring organizations

• Strong analytical skills, including quantitative skills and ability to work effectively with data, reviewing input and analyzing it effectively

• Must be willing to travel (domestically & internationally) greater than 50% with travel schedule fluctuating based on clinical trial enrollments and program needs

• Excellent written and verbal communication skills

Preferred Education, Experience and Skills

• Experience in pre-clinical and/or clinical research, including experience working with neurosurgical device(s)

• Experience with local drug delivery in the CNS

• Expertise in evaluation of various neurosurgical devices and image-guided neurosurgical products

• Proven ability and track record to work with cross-functional teams across multiple simultaneous projects 

• Excellent leadership skills with an ability to establish credibility across various functions

• Strong organizational and time management skills

• Expertise with Microsoft modules, neuronavigational and other technology applications

• High level of integrity with a mastery of relevant regulatory requirements for clinical trials

AskBio Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job‐related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at (919) 561-6210 or sending us an email at careers@askbio.com.

Agencies:  Please do not contact any employee at AskBio about this requisition.  Any resume submitted by a recruitment agency to any employee at AskBio, through any medium, will be deemed the sole property of AskBio unless the agency was engaged by AskBio Talent Acquisition team to recruit for that position.  All agencies must have a prior executed service agreement with AskBio prior to any search engagement.  If a candidate who was submitted outside of the AskBio agency process is hired by AskBio, no fee or payment of any kind will be paid to the agency.