Voyager Therapeutics is seeking an experienced, highly motivated Senior Field Clinical Engineer to provide field procedural support of neurosurgical clinical research including clinical trials and new technology assessments. This role is newly created and will collaborate with our clinical development staff to provide education to investigators, research staff and institutional personnel at clinical trial/project sites. The individual will serve as a technical conduit between neurosurgeons and Voyager. S/he will maintain expert knowledge and consult on technical and clinical advancements. S/he will identify and routinely use the most effective, cost efficient and best practices and will continually evaluate the effectiveness and appropriateness of relevant field activities.
- Help with identification and evaluation of quality neurosurgical centers, appropriate Voyager Clinical Studies.
- Develop and assist with training of facility staff on the requirements of the study as directed and share best practices, while encouraging the site teams to adhere to GCP, regulations and norms, protocol and surgical / procedural manuals
- Attend procedures to support the study as required and provide feedback to clinical and Voyager organization on the evaluation of quality and deployment of technology and surgical procedures
- Continually work with clinical teams in support of study needs to meet corporate objectives. May assist in activities to help meet enrollment objectives, promote protocol and regulatory compliance, produce training documentation, and provide continuous technical support.
- Manage day-to day operations of the imaging core vendor to ensure efficient work process and deliverables are met according to study and corporate timelines.
- Work effectively on internal cross-function program teams in support of new technology including new surgical devices and provide support across functional areas to help develop new product and procedural iterations and technical support.
- Provide product feedback, comments and suggestions and work with clinical development and neurosurgeons to create and deploy educational modules and materials.
- Collaborate with the clinical research department as needed on clinical trial design, clinical data collection requirements, investigator training needs, and trial execution.
- Coordinates clinical evaluation of products. Collects and studies information about new and existing products and provides updates to clinical team.
- Maintains expert status and continuing clinical and technical proficiency in product expertise that goes beyond features and benefits, focusing also on design, development, clinical application.
- nterprets results in preparation for product applications by evaluating clinical and scientific and risk data and literature, stays abreast of current clinical practice.
- Participates in and supports audits as required.
- Participate in root cause analysis, preventive or corrective actions, effectiveness monitoring, and other quality metrics.
- Builds and maintains relationships with neurosurgical KOLs.
- Degree in Biomedical or related Engineering, Biological Sciences, Nursing, or a related field.
- 3+ years of relevant clinical experience in CNS Navigation Deep Brain Stimulation (DBS).
- Working knowledge of MRI imaging modalities and navigation systems
- Current knowledge of quality DBS centers in U.S. and beyond, ability to research and evaluate new centers.
- Excellent communication skills, including demonstrated written and verbal communication, interpersonal, facilitation, solid teaching and presentation skills
- Strong organizational skills including project management, personal organization organizational, time management and follow-up skills, with the ability to meet deadlines as well as the ability to help others work to shared deliverables and deadlines.
- Strong analytical skills, including good quantitative skills and ability to work effectively with data to review input and analyze effectively. Strong, hands-on computer skills with Microsoft modules and other applications
- Evaluation, originality and/or ingenuity required.
- Ability to travel (domestic and internationally) up to 50% and to travel flexibly, with travel schedule fluctuating based on patient enrollment and program needs.
- Excellent reputation for building relationships across various levels of an organization, including with clinical/medical/surgical KOLs.
- Positive and professional attitude, passionate about work, science and technology, in the service of clinical study subjects and site teams, as well as patients and their health care practitioners associated with relevant medical interventions
- Effectively represents Voyager as a technical clinical expert in the field.