Surgical Delivery Liaison

Description:

The SDL is a field-based scientific expert who offers medical oversight and management for a team dedicated to closely engaging with clinical sites. This encompasses all aspects related to protocol adherence, surgical procedures, medical guidance, and scientific support for the program.

Key Responsibilities:

• Collaborate with internal stakeholders, including Clinical Operations, Global Therapeutics, and Medical Affairs, to:

• Support the development and implementation of surgical training plans and strategies.
• Assist in the creation of study materials pertaining to surgical procedures.

• Contribute to the training and qualification of investigators at study sites. Evaluate procedures, provide written feedback to the team, and conduct retraining when necessary.

• Conduct surgical training sessions for study investigators and offer support and oversight for surgeons based in Europe.

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

• Work closely with Clinical Operations to plan and execute study wet lab training sessions, taking the lead when necessary.

• Provide accurate, non-promotional scientific information related to the scientific rationale and study criteria to study sites using approved resources.

• Offer high-quality support for inquiries regarding protocol, enrollment, education, and surgical matters.

• Stay up-to-date with clinical knowledge, published data, and trial progress and competitive product studies.

• Support relevant education initiatives at Investigator Meetings (IMs) as per clinical study plans when requested.

• Establish strong communication channels with Principal Investigators (PI), study physicians, and their teams for peer-to-peer scientific exchanges on disease, clinical unmet needs, and clinical trials.

• Ensure ongoing compliance with Standard Operating Procedures (SOPs), Good Clinical Practice

(GCP), and other relevant guidelines and processes.

Requirements:

• Minimum of a graduate-level degree (BSc, BS) or higher.

• A minimum of 5 years of relevant experience in the pharmaceutical industry or equivalent academic background.

• Experience in a CRO health-related company, hospital Operating Room, or surgical training is required (or a combination of the above).

• Preferably, expertise in therapeutic areas such as Ophthalmology/Retina and/or gene therapy delivery.

• Understanding of clinical trial methodology and management is essential.

• Excellent communication and interpersonal skills.

• Quick assimilation of information, clear presentation of clinical data, and effective discussion of program's surgical requirements.

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

• Willingness to travel, primarily within the European region, with an expected field presence of 50-75%.