Clinical Delivery Liaison (Surgical Trainer)
Who we are
REGENXBIO is an exceptional place to work. You'll have the opportunity to collaborate with some of the best and the brightest people, touch amazing science, and be a part of extraordinary plans. Our core values: Trust, Accountability, Perseverance, and Innovation drive everything we do. We aim to bring these values to life every day with all that we do, and we believe that what we do matters - to patients, to their families, and to their communities.
The Opportunity
As the Clinical Delivery Liaison, you will be responsible for conducting the surgical training of study investigators, assisting the implementation of the surgical training plans and strategy, and assisting with the development of surgical training materials. Position is focused in Ophthalmology/ Retina with opportunities to cover other therapeutic areas. The position will require travel to study sites and must comply with study and site OR requirements.
What You'll Be Doing
- Assist with training and qualification of Investigators at study sites. Evaluate procedures, provide written feedback to the team and perform retraining if necessary.
- Work with internal team (Clinical, Operations and Medical Affairs) and CRO to prepare study related documents related to the surgical procedure.
- Work with internal team and CRO to ensure clinical site compliance with trial protocol, surgical procedure manual, GCP, and regulatory guidelines.
- Work to ensure appropriate documentation for the Clinical Trial Master File.
- Work with Clinical and Operations to plan and execute study wet lab training sessions and lead training.
- Assist with clinical trial site, Investigator training and retraining on delivery procedure and OR process.
- Build relationships with study Investigators and gain insight from the field for the team.
- Position is field-based, traveling 75% of the time.
- It is imperative that REGENXBIO employees embody our core values by working collaboratively, building strong relationships and using clear communication to meet shared objectives.
We set our employees up for success. To be successful in this role and help us achieve our goals, we are looking for someone with the following skills and qualifications:
- 5+ years of surgical training and OR experience required. Therapeutic area expertise in Ophthalmology/ Retina and/ or gene therapy delivery.
- 3+ years Biotechnology or biopharmaceutical industry strongly preferred; direct experience with gene therapy a plus
- Superior medical writing, project management, interpersonal skills.
- Excellent communication and presentation skills and the ability to lead interdisciplinary training.
- Ability to lead and manage high level projects.
- Ability to proactively predict issues and solve problems.
- Diplomacy and positive influencing abilities
- Ability to lift up to 50 lbs
- Ability to stand in place for at least 4 hours at a time.
- Ability to push/pull machines on wheels (up to 300 lbs)
- Must be able to perform detailed, delicate, and difficult manipulative skilled tasks such as loading of needles & syringes, and using the microjector
- Must be able to discern colors under microscope
Why Should You Apply?
By joining REGENXBIO, you will have the opportunity to be a part of a growing company and incredible team passionate about developing novel AAV gene therapy products to our patients. In addition, professional development is important to us. By joining our team, you’ll have the opportunity to be exposed to challenging projects and development resources to help you grow personally and professionally.
We are proud to offer a comprehensive rewards package which includes a market-competitive base salary, an annual performance-based bonus program, stock grants at all levels, and benefits such as health, dental, and vision insurance, retirement plan with 401(k) match, summer hours, and more! The estimated compensation range for this role is $151,000 to $204,000 annually. The actual salary offered to the final candidate depends on a number of factors such as relevant work experience, skills, education, and years of experience.
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