Surgical Specialist Gene Therapy Delivery- CNS

Asklepios BioPharmaceutical Inc. (AskBio) is a leading clinicalstage gene therapy company founded in 2001 based on the work of adenoassociated virus (AAV) gene therapy visionary and pioneer Jude Samulski PhD. Since that time our commitment to developing lifesaving medicines that can potentially cure genetic diseases has never wavered.

At AskBio weve built a foundation of therapeutic programs AAV manufacturing and a rich portfolio of patented technology. Our therapeutic focus includes neuromuscular central nervous system cardiovascular and metabolic diseases with clinical trials underway for Pompe disease Parkinsons disease and congestive heart failure. Our gene therapy platform includes Pro10 an industryleading proprietary cell line manufacturing process and an extensive AAV capsid and promoter library.

We became a whollyowned independently operated subsidiary of Bayer AG in late 2020 as a cornerstone of its newly formed Cell & Gene Therapy (CGT) platform. Our global headquarters is in Research Triangle Park NC. Additionally we have significant operations in Philadelphia PA Columbus OH Scotland France Germany and Spain.

Our vision: Pioneering science to create transformative molecular medicines.

Our mission: Lead innovative science and drive clinical outcomes to transform peoples 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 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 whats right in every situation. Make clear commitments and follow through.

Asklepios BioPharmaceutical Inc. (AskBio) is a leading clinicalstage gene therapy company founded in 2001 based on the work of adenoassociated virus (AAV) gene therapy visionary and pioneer Jude Samulski PhD. Since that time our commitment to developing lifesaving medicines that can potentially cure genetic diseases has never wavered.

At AskBio weve built a foundation of therapeutic programs AAV manufacturing and a rich portfolio of patented technology. Our therapeutic focus includes neuromuscular central nervous system cardiovascular and metabolic diseases with clinical trials underway for Pompe disease Parkinsons disease and congestive heart failure. Our gene therapy platform includes Pro10 an industryleading proprietary cell line manufacturing process and an extensive AAV capsid and promoter library.

We became a whollyowned independently operated subsidiary of Bayer AG in late 2020 as a cornerstone of its newly formed Cell & Gene Therapy (CGT) platform. Our global headquarters is in Research Triangle Park NC. Additionally we have significant operations in Philadelphia PA Columbus OH Scotland Germany and Spain.

Our vision: Pioneering science to create transformative molecular medicines.

Our mission: Lead innovative science and drive clinical outcomes to transform peoples 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 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 whats right in every situation. Make clear commitments and follow through.
• Champion continuous quality improvement by evaluating methods and approaches and recommending efficient and/or novel approaches.

Position Summary

The 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 Surgical Specialist will work closely with the Senior Director and Associate Director CNS Gene Therapy Delivery at AskBio. This individual will receive technical training and all jobrelated knowledge required through training provided from these team members.

The 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 costefficient best practices and will continually evaluate the efficacy and appropriateness of relevant advances in the field of CNS Gene Therapy.

The Surgical Specialist will work collaboratively with regulatory affairs in support of devicerelated regulatory filings associated with multinational clinical investigations.

This role will be based in the Edinburgh UK or Heidelberg Germany office and will report to the Senior Director CNS 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 sitespecific 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 and Associate 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
• Assist in interpreting results in preparation for product/device applications by evaluating clinical scientific and risk data in the literature staying abreast of current clinical neurosurgical practice norms

Minimum Requirements

• Bachelors degree in biology nursing or related field with 8 years relevant work experience
• Experience in preclinical and/or clinical research including experience working with neurosurgical device(s)
• Familiarity with brain imaging modalities including MRIguided brain delivery
• Expertise in partnering effectively with neurosurgeons and staff in the operating room environment
• Excellent written and verbal communication skills
• High level of integrity with a mastery of relevant regulatory requirements for neurosurgical clinical trials
• 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) at a minimum of 5070 with travel schedule fluctuating based on clinical trial enrollments and program needs

Preferred Education Experience and Skills

• Experience with gene therapy drug and/or device development

• Expertise in evaluation of various neurosurgical devices and imageguided neurosurgical products
• Proven ability and track record to work with crossfunctional 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

Asklepios BioPharmaceutical 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 jobrelated 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 ator sending us an email at .

Asklepios BioPharmaceutical 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 jobrelated 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 ator sending us an email at .

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.