Surgical Delivery Liaison - Sponsor dedicated

The Surgical Delivery Liaison is responsible for assisting in developing and implementing the surgical training plans and strategy, assists with developing surgical training materials, and conducts surgical training of study Investigators, supporting the RGX-314 program clinical trials within the Eye Care portfolio.

The SDL is a field based scientific expert that provides field medical oversight and management for team responsible for high touch engagement with clinical sites for all protocol, surgical, medical and scientific related support for this program.

Main Responsibilities

• Works with internal stakeholders [Clinical Operations, Global Therapeutics, and Medical Affairs] to: Support develop and implement surgical training plans and strategy; and, assists in develop study material related to the study surgical procedure

• Assist with training and qualification of investigators at study sites.  Evaluate procedures, provide written feedback to team and perform retraining if necessary.

• Conducts surgical training of study investigators, support and oversight for Europe based surgeons

• Ensure clinical site compliance with trial protocol and surgical procedure manual

• Work with Clinical Operations to plan and execute study wet lab training sessions and lead training

• Ensure provision of accurate and non-promotional scientific information related to the scientific rationale and study criteria of studies to study sites using approved resources.

• Ensure high quality support for protocol/enrollment/education questions and surgical related items.

• Keep up to date with clinical knowledge, published data, and trial work for AbbVie and competitive product studies.

• Support relevant education at Investigator Meetings (IMs) in line with clinical study plans, as requested

• Ensure development of strong communication links with Principal Investigators (PI), study physicians and their staff to engage in peer-to-peer scientific exchange regarding disease, clinical unmet needs and clinical trials

• Ensure compliance with SOPs (Standard Operating Procedures), GCP (Good Clinical Practice), and other relevant guidelines/processes on an ongoing basis

Requirements

• Graduate level (BSc, BS) or higher

• Minimum 5 years relevant experience in pharmaceutical industry or equivalent academic background

• CRO health-related company, hospital Operating Room or surgical training experience (or a combination of above).  Surgical training and Operating Room experience required.

• Therapeutic area expertise preferred in: Ophthalmology/Retina and/or gene therapy delivery.

• Clinical trials experience and understanding of clinical trial methodology and managementCommunication and strong interpersonal skills

• In-depth knowledge of the applicable GXP regulations, Good Clinical Practices, ICH Guidelines and National and European Codes of Practice

• Ability to assimilate information quickly, present clinical data clearly and concisely and discuss the surgical needs of the program

• Ability to work autonomously, in a field-based setting, while contributing positively to the Clinical Site Management function

• Ability to drive performance of self and others

• Highest ethical standards

• Project management skills – to deliver on complex tasks within timeframe and manage milestones

• Ability to work in a matrix management environment

• Proactive problem-solving skills

• Willingness to travel, primarily within Europe region, expected time being on the field: 50-75%

• 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 and syringes, and using the microjector

• Must be able to discern colors under microscope